Jens Ivar Brox

• Sveinall, Håkon; Røe, Cecilie; Engebretsen, Kaia Beck; Skatteboe, Sigrid; Pripp, Are Hugo & Brox, Jens Ivar [Show all 7 contributors for this article] (2026). Patient expectations assessed before randomisation and after the first treatment session, and their associations with pain outcome at 3 months in patients with tennis elbow: a secondary analysis of a randomised controlled feasibility trial in Norwegian secondary care. BMJ Open. 16(9). doi: 10.1136/bmjopen-2026-122686. Full text in Research Archive Show summary

  Objective: To evaluate patients' expectations of pain improvement before randomisation (T1) and after the first treatment (T2), and to examine how expectations at these two time points were associated with pain outcome measured at 3 months (T3). Design: Exploratory secondary analyses of a three-arm, randomised controlled feasibility trial in patients with tennis elbow comparing heavy slow resistance training, shock wave therapy and advice (1:1:1). Setting: Outpatient clinic at Oslo University Hospital. Participants: Adults with lateral epicondylalgia, commonly known as tennis elbow. Main outcome measures: Expected pain was rated on a Numeric Rating Scale (NRS, 0-10) at T1 and T2. Present pain (NRS, 0-10) was reported at 3 months (T3). Changes in expectations from T1 to T2 were summarised descriptively. Univariable linear regressions assessed associations between T3 pain and expectations at T1 and T2, treatment group and baseline factors. Explained variance was quantified by R2. Multivariable models including demographics and baseline pain were evaluated via adjusted R2. Results: Fifty-four participants were included. In the shock wave group, nine (47%) came to expect greater improvement from T1 to T2; by contrast, in the advice group, seven (41%) expected less improvement. Expectations at T1 were not associated with T3 pain, whereas expectations at T2 were positively associated with T3 pain (b=0.61, 95% CI 0.33 to 0.89, p<0.01, R2=0.27), suggesting that higher expected pain at T2 was associated with higher reported pain at T3. Adding education and baseline pain increased explained variance modestly (R2 from 0.27 to 0.32). Conclusion: In this study, expectations measured after randomisation and one treatment session were associated with pain at 3 months for patients with tennis elbow. Larger, prospectively designed studies should investigate how postrandomisation expectations relate to clinical outcomes in non-blinded musculoskeletal trials.

• Holtedahl, Robin; Hott, Alexandra Christine; Hansen, Inger Johanne Widding; Bjørneboe, John Andreas & Brox, Jens Ivar (2026). Magnitude of the placebo response across non-surgical treatment modalities used for knee osteoarthritis: A meta-analysis with meta-regression. Osteoarthritis and Cartilage Open. 8(3). doi: 10.1016/j.ocarto.2026.100861. Full text in Research Archive
• Bjorland, Siri; Bjørneboe, John Andreas; Røe, Cecilie; Taso, Mirad; Engebretsen, Kaia Beck & Skatteboe, Sigrid [Show all 9 contributors for this article] (2026). Cognitive functional therapy for persistent neck pain. Pain Management. p. 1–9. doi: 10.1080/17581869.2026.2625646. Full text in Research Archive Show summary

  Aims: Persistent neck pain is a leading cause of years lived with disability. The aim of the current study is to describe and evaluate cognitive functional therapy for patients with persistent neck pain. Methods: We recruited 74 patients (73% women) aged 22–76 years, with persistent neck pain. The outcomes were neck pain at activity and rest measured by 11-point numeric rating scales (NRS), disability by Neck Disability Index (NDI) (0–100), Fear Avoidance Beliefs Questionnaire (FABQ), Hopkin Symptom Check List (HSCL-10) at baseline and post-treatment. The treatment program included 5 sessions and focused on cognitive strategies and exposure to physical activities. Results: Sixty (81%) patients had follow-ups. Neck pain during activity was reduced by a mean of 3.3 (95% Confidence interval (CI) 2.6 to 3.2) and 2.5 (95% CI 1.9 to 3.1) at rest. NDI was reduced by 16.3 (95% CI 12.0–20.5). Similar large improvements were observed for FABQ and HSCL-10. Ninety-eight percent of the participants reported that they would recommend the program to other patients. Conclusions: Clinically relevant improvements were observed in pain, disability, fear-avoidance beliefs, and emotional distress following CFT in patients with persistent neck pain.

• Bjørneboe, John Andreas; Brox, Jostein Skranes; Myhre, Kjersti; Taso, Mirad; Werner, Erik Lønnmark & Røe, Cecilie [Show all 7 contributors for this article] (2025). Henvisninger til spesialisthelsetjenesten for pasienter med smerter i nakke og rygg. Tidsskrift for Den norske legeforening (Tidsskriftet). ISSN 0029-2001. 145(9). doi: 10.4045/tidsskr.24.0324. Full text in Research Archive
• Røe, Cecilie; Heide, Marte; Søberg, Helene Lundgaard; Brunborg, Cathrine; Hoksrud, Aasne Fenne & Myhre, Kjersti [Show all 8 contributors for this article] (2025). One-Year Trajectory of Pain, Function, and Health-Related Quality of Life in Patients With Plantar Fasciopathy. Journal of Foot and Ankle Research. 18(3). doi: 10.1002/jfa2.70067. Full text in Research Archive
• Taso, Mirad; Sommernes, Jon Håvard; Sundseth, Jarle Østberg; Pripp, Are Hugo; Bjorland, Siri & Engebretsen, Kaia Beck [Show all 9 contributors for this article] (2025). Surgical versus Nonsurgical Treatment for Cervical Radiculopathy. NEJM Evidence. 4(4). doi: 10.1056/evidoa2400404. Full text in Research Archive Show summary

  Background Cervical radiculopathy is typically caused by disc herniation or spondylosis. Few trials have compared the efficacy of surgical versus nonsurgical treatment for these conditions. Methods We conducted two randomized clinical trials among 180 patients presenting to the Oslo University Hospital in Norway with disabling radicular arm pain and cervical disc herniation (trial 1; n=89) or spondylosis (trial 2; n=91) proven by magnetic resonance imaging or computerized tomography. Patients were randomly assigned in a 1:1 ratio to receive either surgical or nonsurgical treatment. Surgery involved anterior cervical discectomy and fusion. Nonsurgical treatment involved three sessions with physical medicine/rehabilitation physicians and three sessions with physiotherapists for functional and cognitive behavioral support. The primary outcome in both trials was the Neck Disability Index (NDI) score (range, 0 to 100; higher scores indicate greater disability; minimal important difference is 15) at 12 months, which was self-reported by the patients. Results Among the 87 patients in the disc herniation trial with 12-month data (surgical group, n=45; nonsurgical group, n=42), the mean difference in NDI adjusted for baseline was 7.4 (95% confidence interval [CI], 1.6 to 13.3; P=0.01) in favor of surgical treatment. Among the 88 patients in the spondylosis trial with 12-month data (surgical, n=44; nonsurgical, n=44), the mean difference in NDI adjusted for baseline was 2.3 (95% CI, −4.9 to 9.6; P=0.52). In the disc herniation trial, two patients in the nonsurgical group crossed over to have surgery. In the spondylosis trial, 11 patients in the nonsurgical group crossed over to have surgery. There were no serious adverse events. Conclusions In patients with cervical radiculopathy, we found a statistically significant difference for NDI at 12 months in favor of surgical versus nonsurgical treatment in the disc herniation trial, but no difference in the spondylosis trial. (Funded by the Southern and Eastern Norway Regional Health Authority; HSØ#2017057; ClinicalTrials.gov number, NCT03674619.)

• Bjørneboe, John Andreas; Røe, Cecilie; Brox, Jens Ivar; Sveinall, Håkon; Ignatius, Janica Sofia & Wilhelmsen, Maja [Show all 7 contributors for this article] (2025). Responsiveness and minimal important change of neck disability index and numeric pain rating scale for neck patients in the Norwegian neck and back register. European spine journal. ISSN 0940-6719. 34(6), p. 2219–2226. doi: 10.1007/s00586-025-08836-7. Full text in Research Archive Show summary

  Purpose To evaluate the responsiveness and the minimal important change (MIC) of Neck Disability Index (NDI) and pain during activity by the numeric rating scale (NRSa) in the Norwegian neck and back registry (NNRR). Materials and methods Participants with neck pain responding to baseline, 6 and 12-months follow-up in the NNRR were included. Responsiveness was calculated using the area under the receiver operating characteristic (ROC). The minimal important change (MIC) was calculated with an anchor-based method and distribution-based methods. For the anchor-based method we used the Patient Global Impression of Change (PGIC) as the anchor. The PGIC was on a 7-point Likert scale, and trichotomized into three ordinal categories. Results A total of 551 patients with neck pain were included. Among these patients, 60% were women with an average age of 48, and 63% had experienced neck pain for more than one year. For improved patients NDI and NRSa had adequate responsiveness at both follow-ups. MIC calculations using an anchor-based method were more accurate than those using a distribution-based method, which fell below the measurement error for the instruments. Using anchor-based calculation of MIC, the MIC for NDI was 17 at the 6-months follow-up and 9 at 12-months follow-up. Correspondingly, NRSa had a MIC of 2.5 at both follow-ups. Conclusion NDI and NRSa were responsive at both 6-months and 12-months follow-up and can be used in registries following patients with neck pain over time.

• Sveinall, Håkon; Brox, Jens Ivar; Engebretsen, Kaia Beck; Hoksrud, Aasne Fenne; Røe, Cecilie & Johnsen, Marianne Bakke (2025). Measurement properties of core outcomes in patients with tennis elbow. Shoulder & Elbow. ISSN 1758-5732. 0(0), p. 1–14. doi: 10.1177/17585732251344264. Full text in Research Archive
• Seip, Andreas Ottersen; Hellum, Christian; Fagerland, Morten; Solberg, Tore; Brox, Jens Ivar & Storheim, Kjersti [Show all 14 contributors for this article] (2025). Surgeon Recommendation and Outcomes of Decompression With vs Without Fusion in Patients With Degenerative Spondylolisthesis. JAMA Network Open. 8(1), p. 1–13. doi: 10.1001/jamanetworkopen.2024.53466. Full text in Research Archive Show summary

  Importance: The ability of surgeons to choose the right patient for fusion in addition to decompression when operating for degenerative spondylolisthesis with symptomatic spinal stenosis is debated. The addition of fusion increases risk, morbidity, and costs but has been claimed to give better results for selected patients. Objective: To investigate whether following surgeons’ opinions regarding fusion was associated with clinical outcomes. Design, Setting, and Participants: This cohort study was conducted alongside the Norwegian Degenerative Spondylolisthesis and Spinal Stenosis randomized clinical trial, which showed noninferiority for decompression alone compared with decompression with fusion. From February 12, 2014, to December 18, 2017, trial surgeons from 16 Norwegian departments denoted their preferred treatment for 222 of 267 patients with symptomatic spinal stenosis and degenerative spondylolisthesis. For this analysis, the clinical outcomes of the patients who were and were not randomized to the recommended treatment were compared. Main Outcome and Measures: The primary outcome was a reduction of at least 30% from baseline to 2 years after surgery on the Oswestry Disability Index, ranging from 0 (no impairment) to 100 (maximum impairment). Secondary outcomes included the Zürich Claudication Questionnaire, leg and back pain scores, and the EuroQol 5-Dimension score. Results: Among 222 patients (155 [70%] female; mean [SD] age, 66.2 [7.7] years), decompression alone was recommended for 112 patients, of whom 59 received only decompression, and additional fusion for 110 patients, of whom 57 received fusion. At 2-year follow-up, 87 of 116 patients (75%) who received surgery in agreement with the surgeons’ recommendations and 77 of 106 (73%) who received surgery in disagreement with the surgeons’ recommendations reached the primary outcome (difference, 2.4 percentage points; 95% CI, −9.1 to 13.9 percentage points). All secondary outcomes were in the same direction as the primary outcome. Conclusions and Relevance: In this cohort study of 222 patients with degenerative spondylolisthesis who participated in a randomized clinical trial, surgeons’ recommendations were not associated with better outcomes than a random allocation when deciding between decompression alone and decompression with instrumented fusion. The results suggest that surgeons performing degenerative spondylolisthesis surgery could rely safely on evidence of operating with decompression alone, despite the conflict of expert opinion.

• Melås, Thea Morin; Bjørneboe, John Andreas; Juel, Niels Gunnar; Wefring, Maren Lunder; Skatteboe, Sigrid & Killingmo, Rikke Munk [Show all 13 contributors for this article] (2025). Self-management versus usual care for greater trochanteric pain syndrome (the HIPS trial): Study protocol for a randomised controlled trial. BMJ Open. 15(4). doi: 10.1136/bmjopen-2024-090688. Full text in Research Archive
• Gjefsen, Elisabeth; Bråten, Lars Christian Haugli; Ponzi, Erica; Dagestad, Magnhild Hammersland; Marchand, Gunn Hege & Kadar, Thomas Istvan Edelsvärd [Show all 22 contributors for this article] (2025). Efficacy of a Tumor Necrosis Factor Inhibitor in Chronic Low-Back Pain With Modic Type 1 Changes: A Randomized Controlled Trial. Arthritis & Rheumatology. ISSN 2326-5191. 77(5), p. 615–623. doi: 10.1002/art.43073. Full text in Research Archive Show summary

  Objective: The efficacy of tumor necrosis factor inhibitors for treating chronic low-back pain with Modic changes is uncertain. This study investigated the superiority of infliximab over placebo in patients with Modic type 1 changes. Methods: In this multicenter, randomized, triple-blind, placebo-controlled trial, patients aged 18 to 65 years with moderate to severe chronic low-back pain and Modic type 1 changes were enrolled from five Norwegian public hospitals between January 2019 and October 2022. Participants were randomly assigned to four intravenous infusions of 5 mg/kg infliximab or placebo. The primary outcome was difference in change in the Oswestry Disability Index (ODI) score from baseline to five months. Secondary outcomes included changes in low-back pain intensity, disability, and health-related quality of life. A linear mixed model was used for efficacy analyses. Results: A total of 128 patients (mean age 43 years, 65.6% women) participated (64 in each group). All patients who received at least one dose of the allocated infusion were included in the primary analyses. The average ODI score (±SD) change was −7.0 (±9.7) in the group who received infliximab and −6.4 (±10.4) in the group who received placebo. The difference in the ODI score change between the two groups was 1.3 ODI points (95% confidence interval −2.1 to 4.6, P = 0.45). Analyses showed no effect of infliximab compared to placebo on secondary outcomes. Adverse event rates were similar between groups. Conclusion: Infliximab did not demonstrate superiority over placebo in reducing pain-related disability in patients with moderate to severe chronic low-back pain with Modic type 1 changes at five months.

• Busse, Jason W; Genevay, Stéphane; Agarwal, Arnav; Standaert, Christopher J; Carneiro, Kevin & Friedrich, Jason [Show all 26 contributors for this article] (2025). Commonly used interventional procedures for non-cancer chronic spine pain: a clinical practice guideline. The BMJ. 388. doi: 10.1136/bmj-2024-079970. Full text in Research Archive Show summary

  Clinical question: What is the comparative effectiveness and safety of commonly used interventional procedures (such as spinal injections and ablation procedures) for chronic axial and radicular spine pain that is not associated with cancer or inflammatory arthropathy? Current practice: Chronic spine pain is a common, potentially disabling complaint, for which clinicians often administer interventional procedures. However, clinical practice guidelines provide inconsistent recommendations for their use. Recommendations: For people living with chronic axial spine pain (≥3 months), the guideline panel issued strong recommendations against: joint radiofrequency ablation with or without joint targeted injection of local anaesthetic plus steroid; epidural injection of local anaesthetic, steroids, or their combination; joint-targeted injection of local anaesthetic, steroids, or their combination; and intramuscular injection of local anaesthetic with or without steroids. For people living with chronic radicular spine pain (≥3 months), the guideline panel issued strong recommendations against: dorsal root ganglion radiofrequency with or without epidural injection of local anaesthetic or local anaesthetic plus steroids; and epidural injection of local anaesthetic, steroids, or their combination. How this guideline was created: An international guideline development panel including four people living with chronic spine pain, 10 clinicians with experience managing chronic spine pain, and eight methodologists, produced these recommendations in adherence with standards for trustworthy guidelines using the GRADE approach. The MAGIC Evidence Ecosystem Foundation provided methodological support. The guideline panel applied an individual patient perspective when formulating recommendations. The evidence: These recommendations are informed by a linked systematic review and network meta-analysis of randomised trials and a systematic review of observational studies, summarising the current body of evidence for benefits and harms of common interventional procedures for axial and radicular, chronic, non-cancer spine pain. Specifically, injection of local anaesthetic, steroids, or their combination into the cervical or lumbar facet joint or sacroiliac joint; epidural injections of local anaesthetic, steroids, or their combination; radiofrequency of dorsal root ganglion; radiofrequency denervation of cervical or lumbar facet joints or the sacroiliac joint; and paravertebral intramuscular injections of local anaesthetic, steroids, or their combination. Understanding the recommendations: These recommendations apply to people living with chronic spine pain (≥3 months duration) that is not associated with cancer or inflammatory arthropathy and do not apply to the management of acute spine pain. Further research is warranted and may alter recommendations in the future: in particular, whether there are differences in treatment effects based on subtypes of chronic spine pain, establishing the effectiveness of interventional procedures currently supported by low or very low certainty evidence, and effects on poorly reported patient-important outcomes (such as opioid use, return to work, and sleep quality).

• Hermansen, Erland; Franssen, Eric; Myklebust, Tor Åge; Indrekvam, Kari; Austevoll, Ivar Magne & Hellum, Christian [Show all 14 contributors for this article] (2025). No long term benefit of decompression of a borderline lumbar spinal stenosis level adjacent to a more stenotic index level. European spine journal. ISSN 0940-6719. 34, p. 5715–5724. doi: 10.1007/s00586-025-09113-3. Full text in Research Archive Show summary

  Purpose: Lumbar spinal stenosis (LSS) frequently involves multiple levels of the spine. Whether to perform single-level decompression (SLD) or multi-level decompression (MLD) in patients with at least one borderline stenotic level adjacent to the primary (index) level, remains debated. Short-term follow-up studies show comparable outcomes for both strategies. This study aimed to assess five-year outcomes in patients with adjacent borderline stenosis. Material: All participants were recruited from the NORDSTEN-SST. Patients with a preoperative adjacent borderline stenosis, defined as Schizas grade B or C, in addition to the index level, were included in the study. The cohort was divided into two groups based on the type of surgical intervention: SLD or MLD. Baseline characteristics and clinical outcomes were recorded for both groups, with follow-up conducted five years postoperatively. Subgroup analysis based on the Schizas grade in the adjacent level were also performed. Results: Out of 437 patients in the NORDSTEN-SST, the 222 with borderline adjacent stenosis were included. Among these, 114 underwent SLD, while 108 underwent MLD. Baseline characteristics were comparable between groups. Mean change in ODI-score was − 16.0 (95% CI -18.9—12.9) for the SLD group and − 18.6 (95% CI -22.1—15.1) for the MLD group, p = 0.26. Subgroup analyses revealed no significant differences between groups in clinical outcomes or need for subsequent spinal surgeries. Conclusion: In this observational study, five-year clinical outcomes in patients operated for lumbar spinal stenosis with a significant stenotic index level were not influenced by additional decompression of preoperative adjacent borderline stenotic levels.

• Enger, Martine Merete; Schmidt, Malte; Nordsletten, Lars; Moosmeyer, Stefan; Pripp, Are Hugo & Melhuus, Knut [Show all 7 contributors for this article] (2025). Physical examination tests in the acute phase of shoulder injuries with negative radiographs: a diagnostic accuracy study. BMC Musculoskeletal Disorders. 26(1). doi: 10.1186/s12891-025-08754-1. Full text in Research Archive Show summary

  Background Rotator cuff tears may easily be missed in patients with acute shoulder trauma. The evidence in support of shoulder physical examination tests has been considered insufficient in reviews and meta-analyses. The purpose of this study was to explore whether physical examination tests can effectively predict or rule out acute full-thickness rotator cuff tears in soft tissue shoulder injuries in emergency departments and primary health care. Methods In a combined primary care walk-in clinic and secondary care orthopaedic emergency department, 120 consecutive patients aged ≥ 40 years with acute shoulder injury without fracture on plain x-rays were enrolled prospectively at the first follow-up within three weeks of the injury. Thirteen physical examination tests and ultrasound screening as reference standard, were performed blinded to each other. Results The median age was 55 years, 51% were female. The prevalence of the target condition rotator cuff full-thickness tear and/or occult fracture of the insertion was 38% (n = 46; 38 tears and 8 occult avulsion fractures). Almost all tears involved the supraspinatus tendon (n = 36). The highest test accuracy was observed for the inability to abduct above 90°, resisted abduction pain and external rotation strength. The sensitivity, specificity and diagnostic odds ratio of the inability to abduct the arm above 90 ° was 84% (95% CI 69–93), 71% (95% CI 59–82) and 12.9 (95% CI 4.8–34.2), respectively, and 66% (51–80), 86% (77–93) and 12.4 (5.0–30.8) for external rotation strength assessed by the small finger test. Combining the inability to abduct above 90° and weakness in external rotation improved the sensitivity to above 90% and the diagnostic odds ratio to above 22, but specificity decreased. Conclusions The present study suggests that two simple tests, the inability to abduct above 90° and weakness in external rotation may effectively predict full-thickness tears of the supra- and infraspinatus and/or occult fracture at their insertion in the acute phase of soft tissue shoulder injuries. The test combination may be useful for selecting patients for advanced imaging and for diagnostic purposes when such imaging is not available. Trial registration The Norwegian Regional Ethics Committee South East (2015/195) on 24th March 2015, and retrospectively registered on ClinicalTrials.gov (NCT02644564) on 31st December 2015.

• Tronstad, Sara; Haug, Knut Jørgen; Myklebust, Tor Åge; Weber, Clemens; Brisby, Helena & Austevoll, Ivar Magne [Show all 16 contributors for this article] (2024). Do patients with lumbar spinal stenosis benefit from decompression of levels with adjacent moderate stenosis? A prospective cohort study from the NORDSTEN study. The spine journal. ISSN 1529-9430. 24(6), p. 1015–1021. doi: 10.1016/j.spinee.2024.01.010. Full text in Research Archive Show summary

  Background: Lumbar spinal stenosis (LSS) is characterized by pain that radiates to the buttocks and/or legs, aggravated by walking and relieved by forward flexion. There is poor correlation between clinical symptoms and severity of stenosis on MRI, and multilevel stenosis has not been described to present worse symptoms or treatment outcomes, compared with patients with single-level stenosis. In patients with one level with severe stenosis combined with an adjacent level with moderate stenosis, the surgeon must decide whether to decompress only the narrowest level or both, to achieve the best possible outcome. The potential benefits of performing surgery on an adjacent moderate stenosis is debated, and the scientific evidence in scarce. Purpose: The aim of the present study was to investigate whether patients with a level of adjacent moderate stenosis, along with an index stenosis, benefitted from a dual-level decompression (DLD) compared with a single-level decompression (SLD). Furthermore, to investigate whether DLD patients had longer duration of surgery and hospital stay, higher rates of complications and/or lower rate of reoperations compared with SLD patients. Study design: Prospective cohort study. Patient sample: We analyzed data from the Norwegian Degenerative Spondylisthesis and Spinal Stenosis study- Spinal Stenosis Trial (NORDSTEN-SST). In this randomized multicenter study, 437 patients were included, evaluating clinical outcomes of three different surgical treatment options for LSS. Patients with degenerative spondylolisthesis were excluded. Method: Based on preoperative MRI, the present analysis included all patients who had a moderate stenosis (defined as Schizas B or C) in addition to a predefined index stenosis (the level with the smallest cross-sectional area). We compared patients who, based on the surgeons` choice, received a dual-level decompression, with those receiving a single-level decompression. Outcome measures: The primary outcome was mean change in the Oswestry Disability Index (ODI) score from baseline to 2-year follow up. Secondary outcomes were proportion of success (30% reduction in ODI score), the Numeric Rating Scales for back and leg pain (NRS), the EuroQol 5-dimensional questionnaire utility index (EQ-5D), the Zurich Claudication Questionnaire (ZCQ), the Global Perceived Effect (GPE)-scale, duration of surgery, duration of hospital stay, perioperative complications and reoperation rates. Results: Among the 222 patients, included in the analysis, 108 underwent DLD and 114 underwent SLD. There was no difference in change scores for any of the investigated patient-reported outcomes between the groups after 2 years. However, the DLD group had longer duration of surgery and longer length of hospital stay. There was no difference in reoperation rates or perioperative complications. Conclusion: This study, alongside the NORDSTEN-LSS trial on patients with adjacent moderate stenosis as well as an index stenosis, showed no superior clinical effectiveness for dual-level surgery compared with single-level surgery.

• Hagerup, Sondre; Brox, Jens Ivar; Banitalebi, Hasan; Indrekvam, Kari; Myklebust, Tor Åge & Hermansen, Erland (2024). The Influence of Spinous Process Union on Clinical Outcomes After Spinous Process Osteotomy for Lumbar Spinal Stenosis After 2 Years: A Secondary Analysis From the NORDSTEN-Study. International Journal of Spine Surgery (IJSS). 18(1), p. 47–53. doi: 10.14444/8576. Full text in Research Archive Show summary

  Background Lumbar spinal stenosis is a prevalent and increasingly important cause of low back pain, leg pain, and walking impairment. Minimally invasive decompressive techniques such as spinous process (SP) osteotomy have become more common in recent years. The main aim of this study was to investigate the proportion of complete SP union and whether complete radiological healing after the osteotomy is associated with superior clinical outcome after 2 years. Methods In this retrospective cohort study, 149 patients were included from the Spinal Stenosis Trial, a part of the NORwegian Degenerative spondylolisthesis and spinal STENosis study. Computed tomography imaging was performed 2 years postoperatively. The number of osteotomies and the number of SP unions were recorded. Patients were divided into groups based on the degree of union: nonunion, partial union, and complete union. Rate of success (>30% improvement in Oswestry Disability Index [ODI]) and mean change in ODI were the primary outcome measures. We compared the differences between baseline and follow-up between the Degree of Union groups. Results The study included 102 of 149 eligible patients. Ten patients (9.8%) were classified as having nonunion, 15 (14.7%) as having partial union, and 77 (75.5%) as having complete union. Of the 155 osteotomies, there were 122 classified as union (77%). The success rate was 74%, with no influence of SP union. The mean change in the ODI was −20.1 (95% CI −37.0, 14.2) with no influence of SP union. Conclusions We found no influence of SP union, classified by computed tomography, on clinical outcome 2 years after SP osteotomy in patients with lumbar spinal stenosis. Clinical Relevance Supplying useful information about SPO to assist surgeons in the choice of decompressive technique. Level of Evidence 2.

• Kgomotso, Eric Loratang; Hellum, Christian; Fagerland, Morten; Solberg, Tore; Brox, Jens Ivar & Storheim, Kjersti [Show all 16 contributors for this article] (2024). Decompression alone or with fusion for degenerative lumbar spondylolisthesis (Nordsten-DS): five year follow-up of a randomised, multicentre, non-inferiority trial. The BMJ. 386, p. 1–11. doi: 10.1136/bmj-2024-079771. Full text in Research Archive Show summary

  Objective: To assess whether decompression alone is non-inferior to decompression with instrumented fusion five years after primary surgery in patients with degenerative lumbar spondylolisthesis. Design: Five year follow-up of a randomised, multicentre, non-inferiority trial (Nordsten-DS). Setting: 16 public orthopaedic and neurosurgical clinics in Norway. Participants: Patients aged 18-80 years with symptomatic lumbar spinal stenosis and a spondylolisthesis of 3 mm or more at the stenotic level. Interventions: Decompression surgery alone and decompression with additional instrumented fusion (1:1). Main outcome measures: The primary outcome was a 30% or more reduction in Oswestry disability index from baseline to five year follow-up. The predefined non-inferiority margin was a -15 percentage point difference in the proportion of patients who met the primary outcome. Secondary outcomes included the mean change in Oswestry disability index, Zurich claudication questionnaire, numeric rating scale for leg and back pain, and EuroQol Group 5-Dimension (EQ-5D-3L) questionnaire. Results: From 12 February 2014 to 18 December 2017, 267 participants were randomly assigned to decompression alone (n=134) and decompression with instrumented fusion (n=133). Of these, 230 (88%) responded to the five year questionnaire: 121 in the decompression group and 109 in the fusion group. Mean age at baseline was 66.2 years (SD 7.6), and 69% were women. In the modified intention-to-treat analysis with multiple imputation of missing data, 84 (63%) of 133 people in the decompression alone group and 81 (63%) of 129 people in the fusion group had a at least a 30% reduction in Oswestry disability index, a difference of 0.4 percentage points. (95% confidence interval (CI) -11.2 to 11.9). The respective results of the per protocol analysis were 65 (65%) of 100 in the decompression alone group and 59 (66%) of 89 in the fusion group, a difference of -1.3 percentage points (95% CI -14.5 to 12.2). Both 95% CIs were higher than the predefined non-inferiority margin of -15%. The mean change in Oswestry disability index from baseline to five years was -17.8 in both groups (mean difference 0.02 (95% CI -3.8 to 3.9)). Results of the other secondary outcomes were in the same direction as the primary outcome. From two to five year follow-up, a new lumbar operation occurred in six (5%) of 123 people in the decompression group and 11 (10%) of 113 people in the fusion group, with a total from baseline to five years of 21 (16%) of 129 people and 23 (18%) of 125, respectively. Conclusions: In participants with degenerative spondylolisthesis, decompression alone was non-inferior to decompression with instrumented fusion five years after primary surgery. Proportions of subsequent surgeries at the index level or an adjacent lumbar level were no different between the groups. Trial registration: ClinicalTrials.gov NCT02051374.

• Sveinall, Håkon; Brox, Jens Ivar; Engebretsen, Kaia Beck; Hoksrud, Aasne Fenne; Røe, Cecilie & Johnsen, Marianne Bakke (2024). Heavy slow resistance training, radial extracorporeal shock wave therapy or advice for patients with tennis elbow in the Norwegian secondary care: a randomised controlled feasibility trial. BMJ Open. 14(12). doi: 10.1136/bmjopen-2024-085916. Full text in Research Archive Show summary

  Objectives To evaluate the feasibility of recruitment, appointment adherence, intervention compliance, acceptance and comprehensibility, in addition to retention rate and data completeness. An ancillary aim was to describe within-group changes in the secondary outcome measures (patient-reported and performance-based). Design A single-centre, three-armed, randomised controlled feasibility trial with a parallel design, with follow-up after 3 and 6 months. Setting Participants were recruited from the outpatient clinic at Oslo University Hospital. Participants Patients with lateral epicondylalgia, commonly known as tennis elbow. Interventions Participants were randomised in a 1:1:1 ratio to heavy slow resistance training, radial extracorporeal shock wave therapy or information and advice. Main outcome measures Feasibility was assessed according to a priori criteria for success. Results In total, 89 patients were screened for eligibility, and 69 (78%) patients were eligible for randomisation. 60 (92%) participants were randomised which gave a recruitment rate of 3.4 per month (against an a priori success cut-off of 3.75). The participants rated all the interventions as acceptable and comprehensive. Only 6 of 19 (32%) did comply with heavy slow resistance training. Retention rate and completeness of data were successful at 3 months. At 6 months, the retention rate was below the criteria for success. Patient-reported and performance-based outcomes improved in all groups. Conclusion The current study shows that the process of recruitment and the retention rate at follow-up can be feasible with minor amendments. Participants had low compliance with heavy slow resistance training mainly due to pain aggravation, which suggests that this intervention was not suitable for patients with tennis elbow. Shock wave therapy and information and advice should be investigated further in a full-scale randomised controlled trial including sham shock wave therapy.

• Heide, Marte; Røe, Cecilie; Mørk, Marianne; Myhre, Kjersti; Brunborg, Cathrine & Brox, Jens Ivar [Show all 7 contributors for this article] (2024). Is radial extracorporeal shock wave therapy (rESWT), sham-rESWT or a standardised exercise programme in combination with advice plus customised foot orthoses more effective than advice plus customised foot orthoses alone in the treatment of plantar fasciopathy? A double-blind, randomised, sham-controlled trial. British Journal of Sports Medicine. ISSN 0306-3674. 58(16), p. 910–918. doi: 10.1136/bjsports-2024-108139. Full text in Research Archive Show summary

  Objectives To assess whether radial extracorporeal shock wave therapy (rESWT), sham-rESWT or a standardised exercise programme in combination with advice plus customised foot orthoses is more effective than advice plus customised foot orthoses alone in alleviating heel pain in patients with plantar fasciopathy. Methods 200 patients with plantar fasciopathy were included in a four-arm, parallel-group, sham-controlled, observer-blinded, partly patient-blinded trial. At baseline, before randomisation, all patients received advice plus customised foot orthoses. Patients were randomised to rESWT (n=50), sham-rESWT (n=50), exercise (n=50) or advice plus customised foot orthoses alone (n=50). Patients in the rESWT and sham-rESWT groups received three treatments. The exercise programme comprised two exercises performed three times a week for 12 weeks, including eight supervised sessions with a physiotherapist. Patients allocated to advice plus customised foot orthoses did not receive additional treatment. The primary outcome was change in heel pain during activity in the previous week per Numeric Rating Scale (0–10) from baseline to 6-month follow-up. The outcome was collected at baseline, and 3, 6 and 12 months. Results The primary analysis showed no statistically significant between-group differences in mean change in heel pain during activity for rESWT versus advice plus customised foot orthoses (−0.02, 95% CI −1.01 to 0.96), sham-rESWT versus advice plus customised foot orthoses (0.52, 95% CI −0.49 to 1.53) and exercise versus advice plus customised foot orthoses (−0.11, 95% CI −1.11 to 0.89) at 6 months. Conclusion In patients with plantar fasciopathy, there was no additional benefit of rESWT, sham-rESWT or a standardised exercise programme over advice plus customised foot orthoses in alleviating heel pain.

• Hermansen, Erland; Indrekvam, Kari; Franssen, Eric; Myklebust, Tor Åge; Austevoll, Ivar Magne & Hellum, Christian [Show all 16 contributors for this article] (2024). A randomized trial on three different minimally invasive decompression techniques for lumbar spinal stenosis. Five years follow-up from the NORDSTEN-SST. European spine journal. ISSN 0940-6719. doi: 10.1007/s00586-024-08514-0. Full text in Research Archive Show summary

  Purpose: The short-term clinical outcome for midline-preserving posterior decompression techniques was comparable. The aim of this study was to evaluate long-term clinical results after three different midline-preserving posterior decompression techniques. Material: In the NORDSTEN spinal stenosis trial (NORDSTEN-SST) 437 patients were randomized to three different midline-retaining posterior decompression techniques: Unilateral laminotomy with crossover (UL), bilateral laminotomy (BL) and spinous process osteotomy (SPO). Primary outcome was the mean change in Oswestry disability index (ODI) score at five-years follow-up. Secondary outcomes were the proportion of patients classified as success, mean change in EQ-5D, ZCQ-score, NRS-score for leg and low back pain, a seven-point Global Perceived Effect (GPE) Scale and proportion of subsequential spinal surgery. Results: The number of patients that completed follow-up data after five years was 358 (82%): In the UL, BL and SPO group the numbers were 122, 119 and 117, respectively. Mean age at baseline was 66.7 (SD 8.2) years, mean BMI was 27.8 (SD 4.1), and 172/358 (48%) were female. In the UL group the mean change was  −18.2 (95% CI  −21.0  −5.4), in the BL group it was  −19.0 (95% CI -21.9–16.1) and in the SPO it was  −18.6 (95% CI  −21.6–15.7) (p = 0.917). No significant differences in the secondary outcomes between the three surgical groups were found, also the subsequent spinal surgery rates were similar. Conclusion: There were no significant differences in patient reported outcomes and subsequent spinal surgery rates after the three different decompression techniques at five-year follow-up.

• Holtedahl, Robin & Brox, Jens Ivar (2024). Compliance with requirements for registration and reporting of results in trials of mesenchymal stromal cells for musculoskeletal disorders: A systematic review. BMJ Open. 14(6). doi: 10.1136/bmjopen-2023-081343. Full text in Research Archive Show summary

  Objective To assess compliance with statutory requirements to register and report outcomes in interventional trials of mesenchymal stromal cells (MSCs) for musculoskeletal disorders and to describe the trials’ clinical and design characteristics. Design A systematic review of published trials and trials submitted to public registries. Data sources The databases Medline, Cochrane Library and McMaster; six public clinical registries. All searches were done until 31 January 2023. Eligibility criteria Trials submitted to registries and completed before January 2021. Prospective interventional trials published in peer-reviewed journals. Data extraction and synthesis The first author searched for trials that had (1) posted trial results in a public registry, (2) presented results in a peer-reviewed publication and (3) submitted a pretrial protocol to a registry before publication. Other extracted variables included trial design, number of participants, funding source, follow-up duration and cell type. Results In total 124 trials were found in registries and literature databases. Knee osteoarthritis was the most common indication. Of the 100 registry trials, 52 trials with in total 2 993 participants had neither posted results in the registry nor published results. Fifty-two of the registry trials submitted a protocol retrospectively. Forty-three of the 67 published trials (64%) had registered a pretrial protocol. Funding source was not associated with compliance with reporting requirements. A discrepancy between primary endpoints in the registry and publication was found in 16 of 25 trials. In 28% of trials, the treatment groups used adjuvant therapies. Only 39% of controlled trials were double-blinded. Conclusions A large proportion of trials failed to comply with statutory requirements for the registration and reporting of results, thereby increasing the risk of bias in outcome assessments. To improve confidence in the role of MSCs for musculoskeletal disorders, registries and medical journals should more rigorously enforce existing requirements for registration and reporting.

• Skatteboe, Sigrid; Røe, Cecilie; Heide, Marte; Brox, Jens Ivar; Ignatius, Janica Sofia & Bratsberg, Andrea Mathisen [Show all 8 contributors for this article] (2024). Responsiveness and minimal important change of specific and generic patient-reported outcome measures for back patients: the Norwegian Neck and Back Register. European spine journal. ISSN 0940-6719. 33(8), p. 2960–2968. doi: 10.1007/s00586-024-08394-4. Full text in Research Archive Show summary

  Purpose To evaluate responsiveness and minimal important change (MIC) of Oswestry Disability Index (ODI), pain during activity on a numeric rating scale (NRSa) and health related quality of life (EQ-5D) based on data from the Norwegian neck and back registry (NNRR). Methods A total of 1617 patients who responded to NNRR follow-up after both 6 and 12 months were included in this study. Responsiveness was calculated using standardized response mean and area under the receiver operating characteristic (ROC) curve. We calculated MIC with both an anchor-based and distribution-based method. Results The condition specific ODI had best responsiveness, the more generic NRSa and EQ-5D had lower responsiveness. We found that the MIC for ODI varied from 3.0 to 9.5, from 0.4 to 2.5 for NRSa while the EQ5D varied from 0.05 to 0.12 depending on the method for calculation. Conclusion In a register based back pain population, the condition specific ODI was more responsive to change than the more generic tools NRSa and EQ5D. The variations in responsiveness and MIC estimates also indicate that they should be regarded as indicative, rather than fixed estimates.

• Franssen, Eric; Weber, Clemens; Myklebust, Tor Åge; Austevoll, Ivar Magne; Brisby, Helena & Hellum, Christian [Show all 12 contributors for this article] (2024). Clinical importance of redundant nerve roots in patients with symptomatic lumbar spinal stenosis: A secondary analysis of NORDSTEN spinal stenosis trial data. Spine. ISSN 0362-2436. 50(14), p. 941–947. doi: 10.1097/BRS.0000000000005160. Full text in Research Archive Show summary

  Study Design. Post-hoc analysis of data from a randomized clinical trial. Objective. To compare preoperative symptoms of patients with lumbar spinal stenosis (LSS) with and without redundant nerve roots (RNR), and to compare the change in clinical outcomes between those two groups 2 years after decompression surgery. Summary of Background Data. RNR are often seen on MRI in patients with spinal stenosis. Previous studies have reported that patients with RNR are older and have worse symptoms at baseline. A meta-analysis from 2018 concluded that this radiological sign could be seen as a negative predictor of outcome. High quality prospective studies are lacking. Methods. Patient characteristics and reported pain and function scores were compared between LSS groups with (RNR+) and without RNR (RNR-) at baseline and after 2 years follow-up. Primary outcome was the mean change in the Oswestry Disability Score (ODI). Secondary outcomes included mean change in scores of the Zurich Claudication Questionnaire (ZCQ) and the numeric rating scale (NRS) for leg and back pain. Results. Out of 416 patients included in the present analysis, 163 (39%) had RNR at baseline. Both groups were similar in regard to patient age, smoking habits, BMI and duration of symptoms. Both groups also showed similar pain and function scores at baseline. The RNR+ group contained a significantly higher proportion of men, patients with severe stenosis and multiple stenotic levels on MRI. At 2-year follow-up the mean change of ODI was −22.1 in the RNR+ group and −17.4 in RNR- group (mean difference 4.7 (95%CI 1.3-8.2) P=0.007). Statistically significant differences were also found for secondary outcomes ZCQ, and NRS leg and back pain favouring the RNR+ group. Conclusion. Patients with RNR had similar baseline characteristics and similar symptoms as patients without. RNR before surgery were associated with better clinical improvement 2 years after decompression.

• Weber, Clemens; Hermansen, Erland; Myklebust, Tor Åge; Banitalebi, Hasan; Brisby, Helena & Brox, Jens Ivar [Show all 14 contributors for this article] (2024). Comparison of Patients Operated for Lumbar Spinal Stenosis with and Without Spondylolisthesis: A Secondary Analysis of the NORDSTEN Trials. Spine. ISSN 0362-2436. 49(19), p. 1332–1338. doi: 10.1097/BRS.0000000000005038. Full text in Research Archive Show summary

  Surgery Comparison of Patients Operated for Lumbar Spinal Stenosis With and Without Spondylolisthesis​​​​​ A Secondary Analysis of the NORDSTEN Trials Weber, Clemens MD, PhDa,b; Hermansen, Erland MD, PhDc,d; Myklebust, Tor Åge PhDe; Banitalebi, Hasan MDf,g; Brisby, Helena MD, PhDh,i; Brox, Jens I. MD, PhDj,k; Franssen, Eric MDl; Hellum, Christian MD, PhDm; Indrekvam, Kari MD, PhDd,n; Harboe, Knut MD, PhDd,l; Rekeland, Frode MDd,o; Solberg, Tore MD, PhDp,q; Storheim, Kjersti PhDr,s; Austevoll, Ivar M. MD, PhDd,o Author Information Spine 49(19):p 1332-1338, October 1, 2024. | DOI: 10.1097/BRS.0000000000005038 Buy SDC Metrics Abstract AI Summary Study Design. Observational cohort study (secondary analysis of two randomized trials). Objective. The aim of this study was to investigate whether function, disability, pain, and quality of life before surgery and patient-reported outcome as well as complication and reoperation rates up to 2 years after surgery differ between lumbar spinal stenosis patients with and

• Engebretsen, Kaia Beck; Taso, Mirad; Bjorland, Siri; Jenssen, Hanne Krogstad; Skaara, Helene Engberg & Brox, Jens Ivar (2024). A functional intervention within a cognitive approach to chronic cervical radiculopathy: Description of the non-surgical treatment arm in a randomised controlled trial evaluating the effectiveness of surgery. BMC Musculoskeletal Disorders. 25(1). doi: 10.1186/s12891-024-07743-0. Full text in Research Archive
• Ignatius, Janica Sofia; Røe, Cecilie; Perrin, Paul B.; Skatteboe, Sigrid; Brox, Jens Ivar & Kielland, Maja Garnaas [Show all 7 contributors for this article] (2024). Influence of nationality on the trajectories of pain, disability and health related quality of life in neck and back patients – The Norwegian Neck and Back Registry. Musculoskeletal Science and Practice. ISSN 2468-8630. 74. doi: 10.1016/j.msksp.2024.103193. Full text in Research Archive Show summary

  Purpose The aim of the current study was to examine differences in trajectories of pain, disability, and health related quality of life (HRQOL) between non-Norwegian and Norwegian patients with neck and back pain over 12 months. Methods The study is based on data from the Norwegian Neck and Back Registry (NNRR). The data include demographics and patient-reported outcome measures such as pain rating, the Oswestry Disability Index and HRQOL. Data were collected at baseline, 6 and 12 months after consultation for neck and back pain in specialist health care. Results A total of 5012 patients were included. We found a significant main effect of nationality. Non-Norwegian patients showed higher levels of pain and disability and lower HRQOL than Norwegian patients. Both patient groups exhibited an improvement in all three outcomes at 6- and 12-month follow-ups. The improvement was similar for pain with the greatest improvement taking place during the first 6 months and then slightly flattening out. For disability and HRQOL, we observed a differential effect over time as a function of nationality. Both groups reported an improvement the first 6 months, however, while the Norwegian patients continued their improvement to 12 months, non-Norwegian patients had increasing disability and lower HRQOL at 12 months. Conclusion Both patient groups improved over the 12-month period. Non-Norwegian patients showed an overall higher level of pain, disability and lower HRQOL compared to Norwegian patients, with a differential effect over time as a function of nationality for disability and HRQOL. Suggesting that future studies should focus on potential systemic barriers that may affect the recovery of neck and back patients based on nationality.

• Grøvle, Lars; Hasvik, Eivind Olay; Holst, Rene; Sætre, Anders; Brox, Jens Ivar & Mathiassen, Ståle [Show all 9 contributors for this article] (2024). Efficacy of naproxen in patients with sciatica: multicentre, randomized, double-blind, placebo-controlled trial. Pain. ISSN 0304-3959. 165(11), p. 2606–2614. doi: 10.1097/j.pain.0000000000003280. Full text in Research Archive Show summary

  This trial assessed the efficacy of naproxen in patients with sciatica in outpatient clinics across 4 Norwegian hospitals. A total of 123 adults with radiating pain below the knee (≥4 on a 0-10 numeric rating scale) and signs consistent with nerve root involvement were included. Participants were randomized to receive either naproxen 500 mg or a placebo twice daily for 10 days. The primary outcome, daily leg pain intensity measured on a 0 to 10 numeric rating scale throughout the treatment period, revealed a statistically significant difference in favor of naproxen, with an adjusted mean difference of -0.5 (95% CI -0.8 to -0.1, P = 0.015). In the naproxen group, the treatment effect was significantly related to time, and over the whole 10-day period, the average adjusted difference was -0.6 (95% CI -0.8 to -0.5). Mean numbers needed to treat for 30% and 50% improvement were 9.9 (95% CI 4.7-15.0) and 20.7 (8.7-32.7), respectively. The adjusted mean difference for back pain was -0.4 (95% CI -0.8 to 0.0), and for Roland Morris Disability Questionnaire for Sciatica, it was -1.5 (95% CI -3.0 to 0.0). No differences were found for sciatica bothersomeness or consumption of rescue medication or opioids. Participants in the naproxen group exhibited an adjusted odds ratio of 4.7 (95% CI 1.3-16.2) for improvement by 1 level on the global perceived change scale. In conclusion, naproxen treatment showed small, likely clinically unimportant benefits compared with placebo in patients with moderate-to-severe sciatica.

• Bjørneboe, John Andreas; Bratsberg, Andrea Mathisen; Brox, Jens Ivar; Skatteboe, Sigrid; Wilhelmsen, Maja & Samuelsen, Kjetil Magne [Show all 10 contributors for this article] (2024). Symptom burden and follow-up of patients with neck and back complaints in specialized outpatient care: a national register study. Scientific Reports. 14(1). doi: 10.1038/s41598-024-53879-3. Full text in Research Archive Show summary

  Back and neck pain are common in the population, especially among immigrants. In Norway’s specialist care system, treating these patients typically involves a multidisciplinary approach based on the biopsychosocial model. However, language and cultural differences may create barriers to participation. Immigrants are often underrepresented in clinical studies, but a register‑based approach can enhance their participation in research. This study aimed to compare both the symptom burden, and treatment, among Norwegians, non‑Norwegians, and patients requiring translator service for back and neck pain within the Norwegian specialist care system. The Norwegian neck and back registry is a National Quality Register, established in 2012 and fully digitized in late 2020. The baseline data includes demographics and patient recorded outcome measures including Oswestry Disability Index, Fear‑Avoidance Beliefs, pain rating on a numeric rating scale, Hopkins Symptom Checklist and EuroQol five‑dimensional questionnaire on health related quality of life. During the two‑year study period, a total of 14,124 patients were invited, and 10,060 (71%) participated. Norwegian patients reported less pain, better function assessed by Oswestry Disability Index, lower fear avoidance beliefs, less emotional distress, and higher health related quality of life compared to non‑Norwegians. We found that patients with female gender, who were younger, more educated and exhibited fear‑ avoidance behavior were significantly more likely to receive multidisciplinary treatment. We found no difference in the proportion of Norwegian and non‑Norwegian patients receiving multidisciplinary treatment [odds ratio (OR) 1.02 (95% confidence interval (CI) 0.90–1.16)]. However, patients needing a translator were less likely to receive multidisciplinary treatment compared to those who didn’t require translation [OR 0.41 (95% CI (0.25–0.66)]. We found that non‑Norwegian patients experience a higher symptom burden compared to Norwegian. We found that both non‑Norwegians and patient in need of translator were to a greater extent recommended treatment in primary health care. The proportion of non‑Norwegians patients receiving multidisciplinary treatment was similar to Norwegians, but those needing a translator were less likely to receive such treatment.

• Indrekvam, Kari; Myklebust, Tor Åge; Austevoll, Ivar Magne; Hermansen, Erland; Banitalebi, Hasan & Bånerud, Ingrid Fjeldheim [Show all 11 contributors for this article] (2024). Responsiveness of the Oswestry Disability Index and Zurich Claudication Questionnaire in patients with lumbar spinal stenosis: evaluation of surgically treated patients from the NORDSTEN study. European spine journal. ISSN 0940-6719. 33(11), p. 4270–4280. doi: 10.1007/s00586-024-08440-1. Full text in Research Archive Show summary

  Purpose To evaluate the responsiveness of the original low back pain specific Oswestry Disability Index (ODI) and the spinal stenosis specific Zürich Claudication Questionnaire (ZCQ), and to investigate cut-off values for clinical “success” for ODI and ZCQ in surgically treated patients with lumbar spinal stenosis (LSS). Methods We included 601 LSS patients (218 with, 383 without degenerative spondylolisthesis) from the NORDSTEN trials. Outcome measures included ODI and ZCQ (symptom severity and physical function scales) with three alternative response parameters: scores at follow-up, absolute and relative changes from baseline to two-year follow-up. Effect size and standardised response mean evaluated internal responsiveness. External responsiveness was assessed by the Spearman rank correlation between patient-reported global perceived effect scale (GPE) and ODI and ZCQ, and receiver operating characteristics (ROC). We evaluated which cut-off values could maximise the percentage of correctly classified pati

• Hellum, Christian; Rekeland, Frode Gurvin; Småstuen, Milada Cvancarova; Solberg, Tore; Hermansen, Erland & Storheim, Kjersti [Show all 17 contributors for this article] (2023). Surgery in Degenerative Spondylolisthesis: Does fusion improve outcome in subgroups? A secondary analysis from a randomized trial (NORDSTEN trial). The spine journal. ISSN 1529-9430. 23(11), p. 1613–1622. doi: 10.1016/j.spinee.2023.06.386. Full text in Research Archive Show summary

  Background context: Patients with spinal stenosis and degenerative spondylolisthesis are treated surgically with decompression alone or decompression with fusion. However, there is debate regarding which subgroups of patients may benefit from additional fusion. Purpose: To investigate possible treatment effect modifiers and prognostic variables among patients operated for spinal stenosis and degenerative spondylolisthesis. Design: A secondary exploratory study using data from the Norwegian Degenerative Spondylolisthesis and Spinal Stenosis (NORDSTEN-DS) trial. Patients were randomized to decompression alone or decompression with instrumented fusion. Patient sample: The sample in this study consists of 267 patients from a randomized multicenter trial involving 16 hospitals in Norway. Patients were enrolled from February 12, 2014, to December 18, 2017. The study did not include patients with degenerative scoliosis, severe foraminal stenosis, multilevel spondylolisthesis, or previous surgery. Outcome measures: The primary outcome was an improvement of ≥ 30% on the Oswestry Disability Index score (ODI) from baseline to 2-year follow-up. Methods: When investigating possible variables that could modify the treatment effect, we analyzed the treatment arms separately. When testing for prognostic factors we analyzed the whole cohort (both treatment groups). We used univariate and multiple regression analyses. The selection of variables was done a priori, according to the published trial protocol. Results: Of the 267 patients included in the trial (183 female [67%]; mean [SD] age, 66 [7.6] years), complete baseline data for the variables required for the present analysis were available for 205 of the 267 individuals. We did not find any clinical or radiological variables at baseline that modified the treatment effect. Thus, none of the commonly used criteria for selecting patients for fusion surgery influenced the chosen primary outcome in the two treatment arms. For the whole cohort, less comorbidity (American Society of Anesthesiologists Classification [ASA], OR = 4.35; 95% confidence interval (CI [1.16-16.67]) and more preoperative leg pain (OR = 1.23; CI [1.02-1.50]) were significantly associated with an improved primary outcome. Conclusions: In this study on patients with degenerative spondylolisthesis, neither previously defined instability criteria nor other pre-specified baseline variables were associated with better clinical outcome if fusion surgery was performed. None of the analyzed variables can be applied to guide the decision for fusion surgery in patients with degenerative spondylolisthesis. For both treatment groups, less comorbidity and more leg pain were associated with improved outcome 2 years after surgery. Trial registration: NORDSTEN-DS ClinicalTrials.gov, NCT02051374.

• Heide, Marte; Mørk, Marianne; Hoksrud, Aasne Fenne; Brox, Jens Ivar & Røe, Cecilie (2023). Responsiveness of specific and generic patient-reported outcome measures in patients with plantar fasciopathy. Disability and Rehabilitation. ISSN 0963-8288. doi: 10.1080/09638288.2023.2267438. Full text in Research Archive Show summary

  Purpose To evaluate and compare responsiveness characteristics for the Foot Function Index revised short form (FFI-RS), RAND-12 Health Status Inventory (RAND-12), and Numeric Rating Scale (NRS), in patients with plantar fasciopathy receiving non-surgical treatment. Materials and methods This study was conducted on a sub-group of patients from an ongoing randomised controlled trial. One-hundred fifteen patients were included. The patient-reported outcome measures (PROMs) were applied at baseline and after 6 months. Responsiveness was calculated using standardised response mean and area under the receiver operating characteristic (ROC) curve. ROC curves were used to compute the minimal important change (MIC) for the outcome measures. Results The region specific FFI-RS had best responsiveness and the NRS at rest had lowest responsiveness. Conclusion FFI-RS were marginally more responsive than the other PROMs. Responsiveness and MIC estimates should be regarded as indicative rather than fixed estimates. Implications for Rehabilitation - The region-specific Foot Function Index Revised Short Form could, based on responsiveness perspectives, be recommended as an outcome measurement for patients with plantar fasciopathy. - Responsiveness and minimal important change estimates are indicative and should be interpreted with caution.

• Hermansen, Erland; Myklebust, Tor Åge; Weber, Clemens; Brisby, Helena; Austevoll, Ivar Magne & Hellum, Christian [Show all 15 contributors for this article] (2023). Postoperative Dural Sac Cross-Sectional Area as an Association for Outcome After Surgery for Lumbar Spinal Stenosis: Clinical and Radiological Results From the NORDSTEN-Spinal Stenosis Trial. Spine. ISSN 0362-2436. 48(10), p. 688–694. doi: 10.1097/BRS.0000000000004565. Full text in Research Archive Show summary

  Study Design. Prospective cohort study. Objective. The aim was to investigate the association between postoperative dural sac cross-sectional area (DSCA) after decompressive surgery for lumbar spinal stenosis and clinical outcome. Furthermore, to investigate if there is a minimum threshold for how extensive a posterior decompression needs to be to achieve a satisfactory clinical result. Summary of Background Data. There is limited scientific evidence for how extensive lumbar decompression needs to be to obtain a good clinical outcome in patients with symptomatic lumbar spinal stenosis. Materials and Methods. All patients were included in the Spinal Stenosis Trial of the NORwegian Degenerative spondylolisthesis and spinal STENosis (NORDSTEN)-study. The patients underwent decompression according to three different methods. DSCA measured on lumbar magnetic resonance imaging at baseline and at three months follow-up, and patient-reported outcome at baseline and at two-year follow-up were registered in a total of 393 patients. Mean age was 68 (SD: 8.3), proportion of males were 204/393 (52%), proportion of smokers were 80/393 (20%), and mean body mass index was 27.8 (SD: 4.2). The cohort was divided into quintiles based on the achieved DSCA postoperatively, the numeric, and relative increase of DSCA, and the association between the increase in DSCA and clinical outcome were evaluated. Results. At baseline, the mean DSCA in the whole cohort was 51.1 mm2 (SD: 21.1). Postoperatively the area increased to a mean area of 120.6 mm2 (SD: 46.9). The change in Oswestry disability index in the quintile with the largest DSCA was −22.0 (95% CI: −25.6 to −18), and in the quintile with the lowest DSCA the Oswestry disability index change was −18.9 (95% CI: −22.4 to −15.3). There were only minor differences in clinical improvement for patients in the different DSCA quintiles. Conclusion. Less aggressive decompression performed similarly to wider decompression across multiple different patient-reported outcome measures at two years following surgery.

• Riksaasen, Anniken; Kaur, Simran; Solberg, Tore; Austevoll, Ivar Magne; Brox, Jens Ivar & Dolatowski, Filip Celestyn [Show all 11 contributors for this article] (2023). Impact of the number of previous lumbar operations on patient-reported outcomes after surgery for lumbar spinal stenosis or lumbar disc herniation. The Bone & Joint Journal. ISSN 2049-4394. 105-B(4), p. 422–430. doi: 10.1302/0301-620X.105B4.BJJ-2022-0704.R1. Full text in Research Archive Show summary

  Repeated lumbar spine surgery has been associated with inferior clinical outcomes. This study aimed to examine and quantify the impact of this association in a national clinical register cohort. This is a population-based study from the Norwegian Registry for Spine surgery (NORspine). We included 26,723 consecutive cases operated for lumbar spinal stenosis or lumbar disc herniation from January 2007 to December 2018. The primary outcome was the Oswestry Disability Index (ODI), presented as the proportions reaching a patient-acceptable symptom state (PASS; defined as an ODI raw score ≤ 22) and ODI raw and change scores at 12-month follow-up. Secondary outcomes were the Global Perceived Effect scale, the numerical rating scale for pain, the EuroQoL five-dimensions health questionnaire, occurrence of perioperative complications and wound infections, and working capability. Binary logistic regression analysis was conducted to examine how the number of previous operations influenced the odds of not reaching a PASS. The proportion reaching a PASS decreased from 66.0% (95% confidence interval (CI) 65.4 to 66.7) in cases with no previous operation to 22.0% (95% CI 15.2 to 30.3) in cases with four or more previous operations (p < 0.001). The odds of not reaching a PASS were 2.1 (95% CI 1.9 to 2.2) in cases with one previous operation, 2.6 (95% CI 2.3 to 3.0) in cases with two, 4.4 (95% CI 3.4 to 5.5) in cases with three, and 6.9 (95% CI 4.5 to 10.5) in cases with four or more previous operations. The ODI raw and change scores and the secondary outcomes showed similar trends. We found a dose-response relationship between increasing number of previous operations and inferior outcomes among patients operated for degenerative conditions in the lumbar spine. This information should be considered in the shared decision-making process prior to elective spine surgery. © 2023 Author(s) et al.

• Holtedahl, Robin; Bøe, Berte Marie Grimsmo & Brox, Jens Ivar (2023). The clinical impact of retears after repair of posterosuperior rotator cuff tears: a systematic review and meta-analysis. Journal of shoulder and elbow surgery. ISSN 1058-2746. 32(6), p. 1333–1346. doi: 10.1016/j.jse.2023.01.014. Full text in Research Archive Show summary

  Background Structural integrity after rotator cuff repair is frequently not achieved, but the clinical consequences of a retear remain disputed. The purpose of this meta-analysis was to analyze the relationships between postoperative cuff integrity and shoulder pain and function. Methods We searched the literature for studies of surgical repair of full-thickness rotator cuff tears published after 1999 describing rates of retear and clinical outcomes and providing sufficient data to estimate effect sizes (standardized mean differences [SMDs]). Baseline and follow-up data of healed and failed repairs were extracted, including shoulder-specific scores, pain, muscle strength, and health-related quality of life. Pooled SMDs, mean differences, and overall change from baseline to follow-up according to structural integrity at follow-up were calculated. Subgroup analysis was performed to assess the influence of study quality on differences. Results This analysis included 43 study arms with 3350 participants. The average age of the participants was 62 years (range, 52-78 years). The median number of participants per study was 65 (interquartile range, 39-108). At a median of 18 months’ follow-up (interquartile range, 12-36 months), 844 repairs (25%) were described as retorn on imaging. The pooled SMD between healed repairs and retears at follow-up was 0.49 (95% confidence interval [CI], 0.37 to 0.61) for the Constant-Murley score, 0.49 (95% CI, 0.22 to 0.75) for the American Shoulder and Elbow Surgeons score, 0.55 (95% CI, 0.31 to 0.78) for other shoulder-specific outcomes combined, 0.27 (95% CI, 0.07 to 0.48) for pain, 0.68 (95% CI, 0.26 to 1.11) for muscle strength, and –0.001 (95% CI, –0.26 to 0.26) for health-related quality of life. The pooled mean differences were 6.12 (95% CI, 4.65 to 7.59) for the Constant-Murley score, 7.13 (95% CI, 3.57 to 10.70) for the American Shoulder and Elbow Surgeons score, and 0.49 (95% CI, 0.12 to 0.87) for pain, all below the commonly suggested minimal clinically important differences. The differences were not significantly affected by study quality and were generally modest compared with overall improvements from baseline to follow-up for both healed and failed repairs. Conclusions The negative impact of retears on pain and function was statistically significant but judged to be of minor clinical importance. The results indicate that most patients may expect satisfactory outcomes despite retears.

• Moosmeyer, Stefan; Ekeberg, Ole Marius; Hallgren, Hanna Bjørnsson; Heier, Ingar; Kvalheim, Synnøve Kristin & Juel, Niels Gunnar [Show all 9 contributors for this article] (2023). Ultrasound guided lavage with corticosteroid injection versus sham lavage with and without corticosteroid injection for calcific tendinopathy of shoulder: randomised double blinded multi-arm study. The BMJ. 383. doi: 10.1136/bmj-2023-076447. Full text in Research Archive
• Olsen, Unni; Lindberg, Maren Falch; Rose, Christopher James; Denison, Eva Marie-Louise; Gay, Caryl & Aamodt, Arild [Show all 11 contributors for this article] (2023). Factors correlated with pain after total knee arthroplasty: A systematic review and meta-analysis. PLOS ONE. 18(3). doi: 10.1371/journal.pone.0283446. Full text in Research Archive Show summary

  Main objective: Systematically review and synthesize preoperative and intraoperative factors associated with pain after total knee arthroplasty (TKA) in patients with osteoarthritis. Methods: Based on a peer-reviewed protocol, we searched Medline, Embase, CINAHL, Cochrane Library, and PEDro for prospective observational studies (January 2000 to February 2023) investigating factors associated with pain after TKA. The primary outcome was pain twelve months after TKA. Pain at three and six months were secondary outcomes. Multivariate random-effects meta-analyses were used to estimate mean correlation (95% CIs) between factors and pain. Sensitivity analysis was performed for each risk of bias domain and certainty of evidence was assessed. Results: Of 13,640 studies, 29 reports of 10,360 patients and 61 factors were analysed. The mean correlation between preoperative factors and more severe pain at twelve months was estimated to be 0.36 (95% CI, 0.24, 0.47; P < .000; moderate-certainty evidence) for more catastrophizing, 0.15 (95% CI; 0.08, 0.23; P < .001; moderate-certainty evidence) for more symptomatic joints, 0.13 (95% CI, 0.06, 0.19; P < .001; very low-certainty evidence) for more preoperative pain. Mean correlation between more severe radiographic osteoarthritis and less pain was -0.15 (95% CI; -0.23, -0.08; P < .001; low-certainty evidence). In sensitivity analysis, the estimated correlation coefficient for pain catastrophizing factor increased to 0.38 (95% CI 0.04, 0.64). At six and three months, more severe preoperative pain was associated with more pain. Better preoperative mental health was associated with less pain at six months. Conclusion and relevance: More pain catastrophizing, more symptomatic joints and more pain preoperatively were correlated with more pain, while more severe osteoarthritis was correlated with less pain one year after TKA. More preoperative pain was correlated with more pain, and better mental health with less pain at six and three months. These findings should be further tested in predictive models to gain knowledge which may improve TKA outcomes.

• Sveinall, Håkon; Wenstad, Per Kristian; Fearon, Angela M.; Skyttemyr, Gjermund; Thornes, Elisabeth & Skaara, Helene Engberg [Show all 10 contributors for this article] (2023). The reliability and validity of the Norwegian version of the Victorian Institute of Sports Assessment for gluteal tendinopathy questionnaire (VISA-G-Norwegian) for patients with greater trochanteric pain syndrome. BMC Musculoskeletal Disorders. 24. doi: 10.1186/s12891-023-06901-0. Full text in Research Archive Show summary

  Background Greater Trochanteric Pain Syndrome (GTPS) is a common chronic musculoskeletal condition that may affect physical function, quality of life and sleep. The Victorian Institute of Sport Assessment-Gluteal questionnaire (VISA-G) has been developed as a Patient-Reported Outcome Measurement (PROM) to address pain, everyday activities, physical activities, and difficulty with weight bearing activities. The aim of the study was to test the reliability, validity and floor and ceiling effects of the Norwegian version of the VISA-G (VISA-G-Norwegian) in a population with GTPS in a specialist health care setting. Methods This psychometric evaluation of the VISA-G-Norwegian questionnaire were conducted with a prospective observational design. The VISA-G was translated into Norwegian following recommended guidelines. A subgroup repeated the VISA-G-Norwegian a week after the initial submission. For the reliability, the Intraclass Correlation Coefficient (ICC2.1), Standard Error of the Measurement (SEM) and the Smallest Detectable Change (SDC95%) were calculated. Internal consistency was measured using a Cronbach´s alpha. Floor and ceiling effects were evaluated, and construct validity was assessed with three a priori hypotheses. Results 78 participants were included in the study of which 47 stable participants undertook the test-retest reliability arm of the study. The ICC2.1 for the total score was 0.85 (95% CI 0.68, 0.92), SEM was 6.6 points and SDC95% 18.4 points. Cronbach`s alpha was 0.77 (95% CI 0.69, 0.84). No floor or ceiling effects were found in the total score, but ceiling effect was found in three of the eight items. For construct validity, one of the three hypotheses were confirmed. VISA-G-Norwegian correlated to the modified Harris Hip Score (mHHS), Oswestry Disability Questionnaire (ODI) and Numeric Pain Rating Scale (NPRS), 0.64, -0.75 and − 0.63 respectively. Conclusion The VISA-G-Norwegian has acceptable reliability and validity, despite ceiling effect of individual items. The large SDC95% should be considered when measuring change in similar cohorts with GTPS. For a potential future version, it would be recommended to consider response options for questions with ceiling effect and the comprehensibility of question eight. Trial registration Registered at ClinicalTrials.gov the 28/02/2020 (NCT04289922).

• Bråten, Lars Christian Haugli; Gjefsen, Elisabeth; Gervin, Kristina; Pripp, Are Hugo; Skouen, Jan Sture & Schistad, Elina Iordanova [Show all 16 contributors for this article] (2023). Cytokine Patterns as Predictors of Antibiotic Treatment Effect in Chronic Low Back Pain with Modic Changes: Subgroup Analyses of a Randomized Trial (AIM Study). Journal of Pain Research. 16, p. 1713–1724. doi: 10.2147/JPR.S406079. Full text in Research Archive Show summary

  Objective: Randomized trials testing the effect of antibiotics for chronic low back pain (LBP) with vertebral bone marrow changes on MRI (Modic changes) report inconsistent results. A proposed explanation is subgroups with low grade discitis where antibiotics are effective, but there is currently no method to identify such subgroups. The objective of the present study was to evaluate whether distinct patterns of serum cytokine levels predict any treatment effect of oral amoxicillin at one-year follow-up in patients with chronic low back pain and Modic changes at the level of a previous lumbar disc herniation. Design: We used data from an overpowered, randomized, placebo-controlled trial (the AIM study) that tested 100 days of oral 750 mg amoxicillin vs placebo three times daily in hospital outpatients with chronic (> 6 months) LBP with pain intensity ≥ 5 on a 0– 10 numerical rating scale and Modic changes type 1 (oedema type) or 2 (fatty type). We measured serum levels of 40 inflammatory cytokines at baseline and analysed six predefined potential predictors of treatment effect based on cytokine patterns in 78 randomized patients; three analyses with recursive partitioning, one based on cluster analysis and two based on principal component analyses. The primary outcome was the Roland–Morris Disability Questionnaire score at one-year follow-up in the intention to treat population. The methodology and overall results of the AIM study were published previously. Results: The 78 patients were 25– 62 years old and 47 (60%) were women. None of the three recursive partitioning analyses resulted in any suggested subgroups. Of all main analyses, the largest effect estimate (mean difference between antibiotic and placebo groups) was seen in a subgroup not predefined as of main interest (Cluster category 3+4; − 2.0, 95% CI: − 5.2– 1.3, RMDQ points; p-value for interaction 0.54). Conclusion: Patterns of inflammatory serum cytokine levels did not predict treatment effect of amoxicillin in patients with chronic LBP and Modic changes.

• Indrekvam, Kari; Bånerud, Ingrid Fjeldheim; Hermansen, Erland; Austevoll, Ivar Magne; Rekeland, Frode Gurvin & Guddal, Maren Hjelle [Show all 10 contributors for this article] (2023). The Norwegian degenerative spondylolisthesis and spinal stenosis (NORDSTEN) study: study overview, organization structure and study population. European spine journal. ISSN 0940-6719. 32(12), p. 4162–4173. doi: 10.1007/s00586-023-07827-w. Full text in Research Archive Show summary

  Purpose To provide an overview of the The Norwegian Degenerative spondylolisthesis and spinal stenosis (NORDSTEN)-study and the organizational structure, and to evaluate the study population. Methods The NORDSTEN is a multicentre study with 10 year follow-up, conducted at 18 public hospitals. NORDSTEN includes three studies: (1) The randomized spinal stenosis trial comparing the impact of three different decompression techniques; (2) the randomized degenerative spondylolisthesis trial investigating whether decompression surgery alone is as good as decompression with instrumented fusion; (3) the observational cohort tracking the natural course of LSS in patients without planned surgical treatment. A range of clinical and radiological data are collected at defined time points. To administer, guide, monitor and assist the surgical units and the researchers involved, the NORDSTEN national project organization was established. Corresponding clinical data from the Norwegian Registry for Spine Surgery (NORspine) were used to assess if the randomized NORDSTEN-population at baseline was representative for LSS patients treated in routine surgical practice. Results A total of 988 LSS patients with or without spondylolistheses were included from 2014 to 2018. The clinical trials did not find any difference in the efficacy of the surgical methods evaluated. The NORDSTEN patients were similar to those being consecutively operated at the same hospitals and reported to the NORspine during the same time period. Conclusion The NORDSTEN study provides opportunity to investigate clinical course of LSS with or without surgical interventions. The NORDSTEN-study population were similar to LSS patients treated in routine surgical practice, supporting the external validity of previously published results.

• Mikkelsen, Eirik; Ingebrigtsen, Tor; Thyrhaug, Anette Moltu; Olsen, Lena Ringstad; Nygaard, Øystein Petter & Austevoll, Ivar Magne [Show all 11 contributors for this article] (2023). The Norwegian registry for spine surgery (NORspine): cohort profile. European spine journal. ISSN 0940-6719. 32(11). doi: 10.1007/s00586-023-07929-5. Full text in Research Archive Show summary

  Purpose: To review and describe the development, methods and cohort of the lumbosacral part of the Norwegian registry for spine surgery (NORspine). Methods: NORspine was established in 2007. It is government funded, covers all providers and captures consecutive cases undergoing operations for degenerative disorders. Patients' participation is voluntary and requires informed consent. A set of baseline-, process- and outcome-variables (3 and 12 months) recommended by the International Consortium for Health Outcome Measurement is reported by surgeons and patients. The main outcome is the Oswestry disability index (ODI) at 12 months. Results: We show satisfactory data quality assessed by completeness, timeliness, accuracy, relevance and comparability. The coverage rate has been 100% since 2016 and the capture rate has increased to 74% in 2021. The cohort consists of 60,647 (47.6% women) cases with mean age 55.7 years, registered during the years 2007 through 2021. The proportions > 70 years and with an American Society of Anaesthesiologists' Physical Classification System (ASA) score > II has increased gradually to 26.1% and 19.3%, respectively. Mean ODI at baseline was 43.0 (standard deviation 17.3). Most cases were operated with decompression for disc herniation (n = 26,557, 43.8%) or spinal stenosis (n = 26,545, 43.8%), and 7417 (12.2%) with additional or primary fusion. The response rate at 12 months follow-up was 71.6%. Conclusion: NORspine is a well-designed population-based comprehensive national clinical quality registry. The register's methods ensure appropriate data for quality surveillance and improvement, and research.

• Hott, Alexandra Christine; Pripp, Are Hugo; Juel, Niels Gunnar; Liavaag, Sigurd & Brox, Jens Ivar (2022). Self-efficacy and Emotional Distress in a Cohort With Patellofemoral Pain. Orthopaedic Journal of Sports Medicine (OJSM). 10(3), p. 1–10. doi: 10.1177/23259671221079672. Full text in Research Archive Show summary

  Background: Patellofemoral pain (PFP) is commonly described and approached in biomechanical terms despite strong evidence that psychosocial factors such as kinesiophobia, emotional distress, and self-efficacy are important in long-standing musculoskeletal pain. Purpose: To describe levels of self-efficacy, emotional distress, kinesiophobia, and widespread pain in a cohort with long-standing PFP and determine their association with measures of pain, function, and health-related quality of life. Study Design: Cross-sectional study; Level of evidence, 3. Methods: Included were 112 patients with PFP (age range, 16-40 years) who had been recruited to a randomized controlled trial. Seven baseline factors (patient sex, pain duration, number of pain sites throughout the body, kinesiophobia [Tampa Scale of Kinesiophobia], emotional distress [Hopkins Symptom Checklist], self-efficacy, and knee extension strength) were investigated for associations with the following outcomes: symptoms of PFP (Anterior Knee Pain Scale), pain (worst and usual), and health-related quality of life (5-level EuroQol-5 Dimensions [EQ-5D-5L]). We used bivariate models and multivariable linear regression models with a stepwise backward removal method to find associations with the outcomes. Internal validation was conducted, and adjusted coefficients after shrinkage are presented. Results: Of the study patients, 28% reported emotional distress (Hopkins Symptom Checklist ≥1.75), 69% reported multiple pain sites, and 33% had widespread pain. The kinesiophobia score was elevated, with a mean score of 35.4 ± 8.2. Self-efficacy was strongly associated with better function (Anterior Knee Pain Scale) and health-related quality of life (EQ-5D-5L) as well as lower pain scores in bivariate and multivariable models. Self-efficacy and emotional distress explained 50% of the variance in health-related quality of life (EQ-5D-5L). Conclusion: Our findings support other studies of PFP suggesting elevated levels of kinesiophobia and emotional distress and higher rates of widespread pain compared with the general population or pain-free controls. Higher self-efficacy was associated with better function and health-related quality of life. Together with emotional distress, it explained half the variance of health-related life quality. The results underline the importance of approaching these patients in a biopsychosocial model. Registration: NCT02114294 (ClinicalTrials.gov identifier).

• Bråten, Lars Christian Haugli; Grøvle, Lars; Wigemyr, Monica; Wilhelmsen, Maja; Gjefsen, Elisabeth & Espeland, Ansgar [Show all 13 contributors for this article] (2022). Minimal important change was on the lower spectrum of previous estimates and responsiveness was sufficient for core outcomes in chronic low back pain. Journal of Clinical Epidemiology. ISSN 0895-4356. 151, p. 75–87. doi: 10.1016/j.jclinepi.2022.07.012. Full text in Research Archive Show summary

  Objectives: The objective of this study was to estimate the minimal important change (MIC) and responsiveness of core patient reported outcome measures for chronic low back pain (LBP) and Modic changes. Study Design and Setting: In the Antibiotics in Modic changes (AIM) trial we measured disability (RMDQ, ODI), LBP intensity (NRS) and health-related quality of life (EQ5D) electronically at baseline, three- and 12-month follow-up. MICs were estimated using Receiver Operating Curve (ROC) curve and Predictive modeling analyses against the global perceived effect. Credibility of the estimates was assessed by a standardized set of criteria. Responsiveness was assessed by a construct and criterion approach according to COSMIN guidelines. Results: The MIC estimates of RMDQ, ODI and NRS scores varied between a 15–40% reduction, depending on including “slightly improved” in the definition of MIC or not. The MIC estimates for EQ5D were lower. The credibility of the estimates was moderate. For responsiveness, five out of six hypotheses were confirmed and AUC was >0.7 for all PROMs. Conclusion: When evaluated in a clinical trial of patients with chronic LBP and Modic changes, MIC thresholds for all PROMs were on the lower spectrum of previous estimates, varying depending on the definition of MIC. Responsiveness was sufficient.

• Banitalebi, Hasan; Aaen, Jørn Ståle; Storheim, Kjersti; Negård, Anne; Myklebust, Tor Åge & Grotle, Margreth [Show all 14 contributors for this article] (2022). A novel MRI index for paraspinal muscle fatty infiltration: reliability and relation to pain and disability in lumbar spinal stenosis: results from a multicentre study. European Radiology Experimental. 6(1), p. 1–10. doi: 10.1186/s41747-022-00284-y. Full text in Research Archive Show summary

  Background Fatty infiltration of the paraspinal muscles may play a role in pain and disability in lumbar spinal stenosis. We assessed the reliability and association with clinical symptoms of a method for assessing fatty infiltration, a simplified muscle fat index (MFI). Methods Preoperative axial T2-weighted magnetic resonance imaging (MRI) scans of 243 patients aged 66.6 ± 8.5 years (mean ± standard deviation), 119 females (49%), with symptomatic lumbar spinal stenosis were assessed. Fatty infiltration was assessed using both the MFI and the Goutallier classification system (GCS). The MFI was calculated as the signal intensity of the psoas muscle divided by that of the multifidus and erector spinae. Observer reliability was assessed in 102 consecutive patients for three independent investigators by intraclass correlation coefficient (ICC) and 95% limits of agreement (LoA) for continuous variables and Gwet’s agreement coefficient (AC1) for categorical variables. Associations with patient-reported pain and disability were assessed using univariate and multivariate regression analyses. Results Interobserver reliability was good for the MFI (ICC 0.79) and fair for the GCS (AC1 0.33). Intraobserver reliability was good or excellent for the MFI (ICC range 0.86–0.91) and moderate to almost perfect for the GCS (AC1 range 0.55–0.92). Mean interobserver differences of MFI measurements ranged from -0.09 to -0.04 (LoA -0.32 to 0.18). Adjusted for potential confounders, none of the disability or pain parameters was significantly associated with MFI or GCS. Conclusion The proposed MFI demonstrated high observer reliability but was not associated with preoperative pain or disability.

• Kristoffersen, Per Martin; Vetti, Nils; Grøvle, Lars; Brox, Jens Ivar; Bråten, Lars Christian Haugli & Grotle, Margreth [Show all 17 contributors for this article] (2022). Amoxicillin did not Reduce Modic Change Oedema in Patients with Chronic Low Back pain - subgroup Analyses of a Randomised Trial (the AIM study). Spine. ISSN 0362-2436. 48(3). doi: 10.1097/BRS.0000000000004513. Full text in Research Archive Show summary

  Study Design - Exploratory subgroup analyses of a randomised trial [Antibiotics in Modic changes (AIM) study]. Objective - The aim was to assess the effect of amoxicillin versus placebo in reducing Modic change (MC) edema in patients with chronic low back pain. Summary of Background Data - The AIM study showed a small, clinically insignificant effect of amoxicillin on pain-related disability in patients with chronic low back pain and MC type 1 (edema type) on magnetic resonance imaging (MRI). Materials and Methods - A total of 180 patients were randomised to receive 100 days of amoxicillin or placebo. MC edema was assessed on MRI at baseline and one-year follow-up. Per-protocol analyses were conducted in subgroups with MC edema on short tau inversion recovery (STIR) or T1/T2-weighted MRI at baseline. MC edema reductions (yes/no) in STIR and T1/T2 series were analyzed separately. The effect of amoxicillin in reducing MC edema was analyzed using logistic regression adjusted for prior disk surgery. To assess the effect of amoxicillin versus placebo within the group with the most abundant MC edema on STIR at baseline (“STIR3” group), we added age, STIR3 (yes/no), and STIR3×treatment group (interaction term) as independent variables and compared the marginal means (probabilities of edema reduction). Results - Compared to placebo, amoxicillin did not reduce MC edema on STIR (volume/intensity) in the total sample with edema on STIR at baseline (odds ratio 1.0, 95% CI: 0.5, 2.0; n=141) or within the STIR3 group (probability of edema reduction 0.69, 95% CI: 0.47, 0.92 with amoxicillin and 0.61, 95% CI: 0.43, 0.80 with placebo; n=41). Compared with placebo, amoxicillin did not reduce MC edema in T1/T2 series (volume of the type 1 part of MCs) (odds ratio: 1.0, 95% CI: 0.5, 2.3, n=104). Edema declined in >50% of patients in both treatment groups. Conclusions - From baseline to one-year follow-up, amoxicillin did not reduce MC edema compared with placebo.

• Brox, Jens Ivar & Werner, Erik Lønnmark (2022). Placebomanipulation or manipulation in acute neck pain? Tidsskrift for Den norske legeforening (Tidsskriftet). ISSN 0029-2001. 142(6). doi: 10.4045/tidsskr.22.0222. Full text in Research Archive
• Dagestad, Magnhild Hammersland; Vetti, Nils; Kristoffersen, Per M; Zwart, John Anker Henrik; Storheim, Kjersti & Bakland, Gunnstein [Show all 12 contributors for this article] (2022). Apparent diffusion coefficient values in Modic changes – interobserver reproducibility and relation to Modic type. BMC Musculoskeletal Disorders. 23, p. 1–12. doi: 10.1186/s12891-022-05610-4. Full text in Research Archive Show summary

  Background Modic Changes (MCs) in the vertebral bone marrow were related to back pain in some studies but have uncertain clinical relevance. Diffusion weighted MRI with apparent diffusion coefficient (ADC)-measurements can add information on bone marrow lesions. However, few have studied ADC measurements in MCs. Further studies require reproducible and valid measurements. We expect valid ADC values to be higher in MC type 1 (oedema type) vs type 3 (sclerotic type) vs type 2 (fatty type). Accordingly, the purpose of this study was to evaluate ADC values in MCs for interobserver reproducibility and relation to MC type. Methods We used ADC maps (b 50, 400, 800 s/mm2) from 1.5 T lumbar spine MRI of 90 chronic low back pain patients with MCs in the AIM (Antibiotics In Modic changes)-study. Two radiologists independently measured ADC in fixed-sized regions of interests. Variables were MC-ADC (ADC in MC), MC-ADC% (0% = vertebral body, 100% = cerebrospinal fluid) and MC-ADC-ratio (MC-ADC divided by vertebral body ADC). We calculated mean difference between observers ± limits of agreement (LoA) at separate endplates. The relation between ADC variables and MC type was assessed using linear mixed-effects models and by calculating the area under the receiver operating characteristic curve (AUC). Results The 90 patients (mean age 44 years; 54 women) had 224 MCs Th12-S1 comprising type 1 (n = 111), type 2 (n = 91) and type 3 MC groups (n = 22). All ADC variables had higher predicted mean for type 1 vs 3 vs 2 (p < 0.001 to 0.02): MC-ADC (10− 6 mm2/s) 1201/796/576, MC-ADC% 36/21/14, and MC-ADC-ratio 5.9/4.2/3.1. MC-ADC and MC-ADC% had moderate to high ability to discriminate between the MC type groups (AUC 0.73–0.91). MC-ADC-ratio had low to moderate ability (AUC 0.67–0.85). At L4-S1, widest/narrowest LoA were for MC-ADC 20 ± 407/12 ± 254, MC-ADC% 1.6 ± 18.8/1.4 ± 10.4, and MC-ADC-ratio 0.3 ± 4.3/0.2 ± 3.9. Difference between observers > 50% of their mean value was less frequent for MC-ADC (9% of MCs) vs MC-ADC% and MC-ADC-ratio (17–20%). Conclusions The MC-ADC variable (highest mean ADC in the MC) had best interobserver reproducibility, discriminated between MC type groups, and may be used in further research. ADC values differed between MC types as expected from previously reported MC histology.

• Taso, Mirad; Sommernes, Jon Håvard; Bjorland, Siri; Zwart, John Anker Henrik; Engebretsen, Kaia Beck & Sundseth, Jarle Østberg [Show all 9 contributors for this article] (2022). What is success of treatment? Expected outcome scores in cervical radiculopathy patients were much higher than the previously reported cut-off values for success. European spine journal. ISSN 0940-6719. doi: 10.1007/s00586-022-07234-7. Full text in Research Archive Show summary

  Purpose Treatment success can be defined by asking a patient how they perceive their condition compared to prior to treatment, but it can also be defined by establishing success criteria in advance. We evaluated treatment outcome expectations in patients undergoing surgery or non-operative treatment for cervical radiculopathy. Methods The first 100 consecutive patients from an ongoing randomized controlled trial (NCT03674619) comparing the effectiveness of surgical and nonsurgical treatment for cervical radiculopathy were included. Patient-reported outcome measures and expected outcome and improvement were obtained before treatment. We compared these with previously published cut-off values for success. Arm pain, neck pain and headache were measured by a numeric rating scale. Neck disability index (NDI) was used to record pain-related disability. We applied Wilcoxon signed-rank test to compare the expected outcome scores for the two treatments. Results Patients reported mean NDI of 42.2 (95% CI 39.6–44.7) at baseline. The expected mean NDI one year after the treatment was 4 (95% CI 3.0–5.1). The expected mean reduction in NDI was 38.3 (95% CI 35.8–40.8). Calculated as a percentage change score, the patients expected a mean reduction of 91.2% (95% CI 89.2–93.2). Patient expectations were higher regarding surgical treatment for arm pain, neck pain and working ability, P < 0.001, but not for headache. Conclusions The expected improvement after treatment of cervical radiculopathy was much higher than the previously reported cut-off values for success. Patients with cervical radiculopathy had higher expectations to surgical treatment.

• Banitalebi, Hasan; Espeland, Ansgar; Anvar, Masoud D; Hermansen, Erland; Hellum, Christian & Brox, Jens Ivar [Show all 14 contributors for this article] (2022). Reliability of preoperative MRI findings in patients with lumbar spinal stenosis. BMC Musculoskeletal Disorders. 23(1), p. 1–9. doi: 10.1186/s12891-021-04949-4. Full text in Research Archive Show summary

  Background Magnetic Resonance Imaging (MRI) is an important tool in preoperative evaluation of patients with lumbar spinal stenosis (LSS). Reported reliability of various MRI findings in LSS varies from fair to excellent. There are inconsistencies in the evaluated parameters and the methodology of the studies. The purpose of this study was to evaluate the reliability of the preoperative MRI findings in patients with LSS between musculoskeletal radiologists and orthopaedic spine surgeons, using established evaluation methods and imaging data from a prospective trial. Methods Consecutive lumbar MRI examinations of candidates for surgical treatment of LSS from the Norwegian Spinal Stenosis and Degenerative Spondylolisthesis (NORDSTEN) study were independently evaluated by two musculoskeletal radiologists and two orthopaedic spine surgeons. The observers had a range of experience between six and 13 years and rated five categorical parameters (foraminal and central canal stenosis, facet joint osteoarthritis, redundant nerve roots and intraspinal synovial cysts) and one continuous parameter (dural sac cross-sectional area). All parameters were re-rated after 6 weeks by all the observers. Inter- and intraobserver agreement was assessed by Gwet’s agreement coefficient (AC1) for categorical parameters and Intraclass Correlation Coefficient (ICC) for the dural sac cross-sectional area. Results MRI examinations of 102 patients (mean age 66 ± 8 years, 53 men) were evaluated. The overall interobserver agreement was substantial or almost perfect for all categorical parameters (AC1 range 0.67 to 0.98), except for facet joint osteoarthritis, where the agreement was moderate (AC1 0.39). For the dural sac cross-sectional area, the overall interobserver agreement was good or excellent (ICC range 0.86 to 0.96). The intraobserver agreement was substantial or almost perfect/ excellent for all parameters (AC1 range 0.63 to 1.0 and ICC range 0.93 to 1.0). Conclusions There is high inter- and intraobserver agreement between radiologists and spine surgeons for preoperative MRI findings of LSS. However, the interobserver agreement is not optimal for evaluation of facet joint osteoarthritis.

• Ekeberg, Ole Marius; Pedersen, Stein Jarle; Natvig, Bård; Brox, Jens Ivar; Biringer, Eva Aaker & Reme, Silje Endresen [Show all 10 contributors for this article] (2022). Making should erpa in simple in general practice: Implementing an evidence-based guideline for shoulder pain, protocol for a hybrid design stepped-wedge cluster randomised study (EASIER study). BMJ Open. 12(1). doi: 10.1136/bmjopen-2021-051656. Full text in Research Archive
• Olsen, Unni; Lindberg, Maren Falch; Rose, Christopher James; Denison, Eva Marie-Louise; Gay, Caryl & Aamodt, Arild [Show all 11 contributors for this article] (2022). Factors Correlated with Physical Function 1 Year after Total Knee Arthroplasty in Patients with Knee Osteoarthritis: A Systematic Review and Meta-analysis. JAMA Network Open. 5(7), p. 1–15. doi: 10.1001/jamanetworkopen.2022.19636. Full text in Research Archive Show summary

  Importance: More than 1 in 5 patients do not experience improved physical function after total knee arthroplasty (TKA). Identification of factors associated with physical function may be warranted to improve outcomes in these patients. Objective: To identify preoperative and intraoperative factors associated with physical function at 12 months after TKA in a systematic review and meta-analysis. Data Sources: Data from January 2000 to October 2021 were searched in Medline, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane Library, and Physiotherapy Evidence Database (PEDro). No language restrictions were applied. Study Selection: Prospective observational studies or randomized clinical trials on factors associated with physical function after TKA in adult patients with osteoarthritis were selected. A prespecified peer-reviewed protocol was followed. Data Extraction and Synthesis: Following the Preferred Reporting Items for Systematic Reviews and Meta-analyses guideline, 2 reviewers independently screened titles and abstracts and judged risk of bias using Quality in Prognosis Studies (QUIPS). Multivariate random-effects meta-analyses were performed to estimate mean correlations between factors and physical function with 95% CIs. Sensitivity analyses were conducted for each QUIPS domain. Certainty of evidence was evaluated using Grading of Recommendations, Assessment, Development and Evaluations (GRADE). This study was registered with the International Prospective Register of Systematic Reviews (PROSPERO). Main Outcomes and Measures: The primary outcome was physical function 12 months after TKA. Secondary outcomes were physical function 3 and 6 months after TKA. All estimates are mean correlations between factors and postoperative function. Positive correlations correspond to better function. Results: Among 12 052 articles, 20 studies (including 11 317 patients and 37 factors) were analyzed. Mean correlation with higher BMI was estimated to be −0.15 (95% CI, −0.24 to −0.05; P = .33; moderate-certainty evidence), while mean correlation with better physical function was estimated to be 0.14 (95% CI, 0.02 to 0.26; P = .03; low-certainty evidence) and mean correlation with more severe osteoarthritis was estimated to be 0.10 (95% CI, 0.01 to 0.19; P = .17; high-certainty evidence). In sensitivity analyses, mean correlation with better physical function was estimated to be 0.20 (95% CI, 0.04 to 0.36; P = .02), and so perhaps a larger coefficient than in the main analysis, while mean correlations were estimated to be similar for other factors (BMI: –0.17; 95% CI, –0.28 to –0.06; P < .001; osteoarthritis severity: 0.10; 95% CI, −0.01 to 0.20; P = .05). Conclusions and Relevance: This study found that higher presurgical BMI was correlated with worse physical function (with moderate certainty) and that better physical function (low certainty) and osteoarthritis severity (high certainty) were correlated with better physical function after TKA. These findings suggest that these factors should be included when testing predictive models of TKA outcomes.

• Hermansen, Erland; Austevoll, Ivar Magne; Hellum, Christian; Storheim, Kjersti; Myklebust, Tor Åge & Aaen, Jørn Ståle [Show all 17 contributors for this article] (2022). Comparison of 3 Different Minimally Invasive Surgical Techniques for Lumbar Spinal Stenosis: A Randomized Clinical Trial. JAMA Network Open. 5(3), p. 1–13. doi: 10.1001/jamanetworkopen.2022.4291. Full text in Research Archive Show summary

  Importance Operations for lumbar spinal stenosis is the most often performed surgical procedure in the adult lumbar spine. This study reports the clinical outcome of the 3 most commonly used minimally invasive posterior decompression techniques. Objective To compare the effectiveness of 3 minimally invasive posterior decompression techniques for lumbar spinal stenosis. Design, Setting, and Participants This randomized clinical trial used a parallel group design and included patients with symptomatic and radiologically verified lumbar spinal stenosis without degenerative spondylolisthesis. Patients were enrolled between February 2014 and October 2018 at the orthopedic and neurosurgical departments of 16 Norwegian public hospitals. Statistical analysis was performed in the period from May to June 2021. Interventions Patients were randomized to undergo 1 of the 3 minimally invasive posterior decompression techniques: unilateral laminotomy with crossover, bilateral laminotomy, and spinous process osteotomy. Main Outcomes and Measures Primary outcome was change in disability measured with Oswestry Disability Index (ODI; range 0-100), presented as mean change from baseline to 2-year follow-up and proportions of patients classified as success (>30% reduction in ODI). Secondary outcomes were mean change in quality of life, disease-specific symptom severity measured with Zurich Claudication Questionnaire (ZCQ), back pain and leg pain on a 10-point numeric rating score (NRS), patient perceived benefit of the surgical procedure, duration of the surgical procedure, blood loss, perioperative complications, number of reoperations, and length of hospital stay. Results In total, 437 patients were included with a median (IQR) age of 68 (62-73) years and 230 men (53%). Of the included patients, 146 were randomized to unilateral laminotomy with crossover, 142 to bilateral laminotomy, and 149 to spinous process osteotomy. The unilateral laminotomy with crossover group had a mean change of −17.9 ODI points (95% CI, −20.8 to −14.9), the bilateral laminotomy group had a mean change of −19.7 ODI points (95% CI, −22.7 to −16.8), and the spinous process osteotomy group had a mean change of –19.9 ODI points (95% CI, −22.8 to –17.0). There were no significant differences in primary or secondary outcomes among the 3 surgical procedures, except a longer duration of the surgical procedure in the bilateral laminotomy group. Conclusions and Relevance No differences in clinical outcomes or complication rates were found among the 3 minimally invasive posterior decompression techniques used to treat patients with lumbar spinal stenosis.

• Garratt, Andrew M.; Furunes, Håvard; Hellum, Christian; Solberg, Tore; Brox, Jens Ivar & Storheim, Kjersti [Show all 7 contributors for this article] (2021). Evaluation of the EQ-5D-3L and 5L versions in low back pain patients. Health and Quality of Life Outcomes. 19. doi: 10.1186/s12955-021-01792-y. Full text in Research Archive Show summary

  Background The EuroQol EQ-5D is one of the most widely researched and applied patient-reported outcome measures worldwide. The original EQ-5D-3L and more recent EQ-5D-5L include three and five response categories respectively. Evidence from healthy and sick populations shows that the additional two response categories improve measurement properties but there has not been a concurrent comparison of the two versions in patients with low back pain (LBP). Methods LBP patients taking part in a multicenter randomized controlled trial of lumbar total disc replacement and conservative treatment completed the EQ-5D-3L and 5L in an eight-year follow-up questionnaire. The 3L and 5L were assessed for aspects of data quality including missing data, floor and ceiling effects, response consistency, and based on a priori hypotheses, associations with the Oswestry Disability Index (ODI), Pain-Visual Analogue Scales and Hopkins Symptom Checklist (HSCL-25). Results At the eight-year follow-up, 151 (87%) patients were available and 146 completed both the 3L and 5L. Levels of missing data were the same for the two versions. Compared to the EQ-5D-5L, the 3L had significantly higher floor (pain discomfort) and ceiling effects (mobility, self-care, pain/discomfort, anxiety/depression). For these patients the EQ-5D-5L described 73 health states compared to 28 for the 3L. Shannon’s indices showed the 5L outperformed the 3L in tests of classification efficiency. Correlations with the ODI, Pain-VAS and HSCL-25 were largely as hypothesized, the 5L having slightly higher correlations than the 3L. Conclusion The EQ-5D assesses important aspect of health in LBP patients and the 5L improves upon the 3L in this respect. The EQ-5D-5L is recommended in preference to the 3L version, however, further testing in other back pain populations together with additional measurement properties, including responsiveness to change, is recommended. © The Author(s) 2021. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made.

• Holtedahl, Robin; Bøe, Berte Marie Grimsmo & Brox, Jens Ivar (2021). Better Short-Term Outcomes After Rotator Cuff Repair in Studies with Poorer Mean Shoulder Scores and Predominantly Small to Medium-Sized Tears at Baseline. A Systematic Review and Meta-Analysis. Arthroscopy: The Journal of Arthroscopy And Related. ISSN 0749-8063. doi: 10.1016/j.arthro.2021.08.019. Full text in Research Archive
• Aaen, Jørn; Austevoll, Ivar Magne; Hellum, Christian; Storheim, Kjersti; Myklebust, Tor Åge & Banitalebi, Hasan [Show all 14 contributors for this article] (2021). Clinical and MRI findings in lumbar spinal stenosis: baseline data from the NORDSTEN study. European spine journal. ISSN 0940-6719. doi: 10.1007/s00586-021-07051-4. Full text in Research Archive Show summary

  Purpose The aim was to describe magnetic resonance imaging fndings in patients planned for lumbar spinal stenosis surgery. Further, to describe possible associations between MRI fndings and patient characteristics with patient reported disability or pain. Methods The NORDSTEN spinal stenosis trial included 437 patients planned for surgical decompression of LSS. The following MRI fndings were evaluated before surgery: morphological (Schizas) and quantitative (cross-sectional area) grade of stenosis, disk degeneration (Pfrrmann), facet joint tropism and fatty infltration of the multifdus muscle. Patients were dichotomized into a moderate or severe category for each radiological parameter classifcation. A multivariable linear regression analysis was performed to investigate the association between MRI fndings and preoperative scores for Oswestry Disability Index, Zurich Claudication Questionnaire and Numeric rating scale for back and leg pain. The following patient characteristics were included in the analysis: gender, age, smoking and weight. Results The percentage of patients with severe scores was as follows: Schizas (C+D) 71.3%, cross-sectional area (<75 mm2 ) 86.8%, Pfrrmann (4+5) 58.1%, tropism (≥15°) 11.9%, degeneration of multifdus muscle (2–4) 83.7%. Regression coefcients indicated minimal changes in severity of symptoms when comparing the groups with moderate and severe MRI fndings. Only gender had a signifcant and clinically relevant association with ODI score. Conclusion In this cross-sectional study, the majority of the patients had MRI fndings classifed as severe LSS changes, but the fndings had no clinically relevant association with patient reported disability and pain at baseline. Patient characteristics have a larger impact on disability and pain than radiological fndings. Trial registration www.ClinicalTrials.gov identifer: NCT02007083, registered December 2013. Keywords Lumbar spinal stenosis · Schizas · DSCA · Pfrrmann · Tropism

• Austevoll, Ivar Magne; Hermansen, Erland; Fagerland, Morten Wang; Storheim, Kjersti; Brox, Jens Ivar & Solberg, Tore [Show all 16 contributors for this article] (2021). Decompression with or without Fusion in Degenerative Lumbar Spondylolisthesis. New England Journal of Medicine. ISSN 0028-4793. 385(6), p. 526–538. doi: 10.1056/NEJMoa2100990. Full text in Research Archive Show summary

  BACKGROUND In patients with lumbar spinal stenosis and degenerative spondylolisthesis, it is uncertain whether decompression surgery alone is noninferior to decompression with instrumented fusion. METHODS We conducted an open-label, multicenter, noninferiority trial involving patients with symptomatic lumbar stenosis that had not responded to conservative management and who had single-level spondylolisthesis of 3 mm or more. Patients were randomly assigned in a 1:1 ratio to undergo decompression surgery (decompressionalone group) or decompression surgery with instrumented fusion (fusion group). The primary outcome was a reduction of at least 30% in the score on the Oswestry Disability Index (ODI; range, 0 to 100, with higher scores indicating more impairment) during the 2 years after surgery, with a noninferiority margin of −15 percentage points. Secondary outcomes included the mean change in the ODI score as well as scores on the Zurich Claudication Questionnaire, leg and back pain, the duration of surgery and length of hospital stay, and reoperation within 2 years. RESULTS The mean age of patients was approximately 66 years. Approximately 75% of the patients had leg pain for more than a year, and more than 80% had back pain for more than a year. The mean change from baseline to 2 years in the ODI score was −20.6 in the decompression-alone group and −21.3 in the fusion group (mean difference, 0.7; 95% confidence interval [CI], −2.8 to 4.3). In the modified intentionto- treat analysis, 95 of 133 patients (71.4%) in the decompression-alone group and 94 of 129 patients (72.9%) in the fusion group had a reduction of at least 30% in the ODI score (difference, −1.4 percentage points; 95% CI, −12.2 to 9.4), showing the noninferiority of decompression alone. In the per-protocol analysis, 80 of 106 patients (75.5%) and 83 of 110 patients (75.5%), respectively, had a reduction of at least 30% in the ODI score (difference, 0.0 percentage points; 95% CI, −11.4 to 11.4), showing noninferiority. The results for the secondary outcomes were generally in the same direction as those for the primary outcome. Successful fusion was achieved with certainty in 86 of 100 patients (86.0%) who had imaging available at 2 years. Reoperation was performed in 15 of 120 patients (12.5%) in the decompression- alone group and in 11 of 121 patients (9.1%) in the fusion group. CONCLUSIONS In this trial involving patients who underwent surgery for degenerative lumbar spondylolisthesis, most of whom had symptoms for more than a year, decompression alone was noninferior to decompression with instrumented fusion over a period of 2 years. Reoperation occurred somewhat more often in the decompressionalone group than in the fusion group. (NORDSTEN-DS ClinicalTrials.gov number, NCT02051374.)

• Schmidt, Malte; Enger, Martine; Pripp, Are Hugo; Nordsletten, Lars; Moosmeyer, Stefan & Melhuus, Knut [Show all 7 contributors for this article] (2021). Interrater reliability of physical examination tests in the acute phase of shoulder injuries. BMC Musculoskeletal Disorders. 22(1), p. 1–9. doi: 10.1186/s12891-021-04659-x. Full text in Research Archive Show summary

  Background The physical examination is one of the cornerstones of the diagnostic process in patients with acute shoulder injuries. The discriminative properties of a given examination test depend both on its validity and reliability. The aim of the present study was to assess the interrater reliability of 13 physical examination manoeuvres for acute rotator cuff tears in patients with acute soft tissue shoulder injuries. Methods In a large walk-in orthopaedic emergency department, 120 consecutive patients ≥40 years of age were included in a diagnostic study. Patients who had follow-up within three weeks of an acute shoulder injury without fracture on radiographs were eligible. Four emergency department physicians participated as examiners. In a subset of 48 patients, the physical examination tests were performed by two physicians, randomly chosen by their work rotation. The physicians were blinded to the findings of each other and the results of the ultrasound screening. The interrater reliability was assessed by Cohen’s kappa, intraclass correlation coefficient (ICC), standard error of measurement (SEM) and Bland-Altman plots depending on whether the examination test result was registered as a binary, ordered categorical or continuous numerical variable. Results The median age was 55.5 years, 46% were female. Twenty-seven percent had a rotator cuff full-thickness tear on ultrasound screening; all but one involved the supraspinatus tendon. Cohen’s kappa for binary tests ranged from excellent to fair. Excellent agreement (kappa > 0.8) was found for the inability to abduct above 90° and abduction strength. External rotation strength expressed substantial agreement (kappa 0.7). The lowest scores were registered for Hawkins` test and the external rotation lag sign (kappa 0.25 and 0.40, respectively). The ICCs for active range of abduction and external rotation were 0.93 (0.88–0.96) and 0.84 (0.72–0.91), whereas the SEM was 15 and 9, respectively. Conclusions The results indicate that examination manoeuvres assessing abduction and external rotation range of motion and strength are more reliable than manoeuvres assessing pain in patients in the acute phase of traumatic shoulder injury. The poor agreement observed is likely to limit the validity in the present setting of two commonly used tests. Trial registration The Norwegian Regional Ethics Committee South East (2015/195).

• Major, Daniel Høgli; Grotle, Margreth; Littlewood, Chris; Brox, Jens Ivar; Matre, Dagfinn & Gallet, Heidi Marie Veeser [Show all 7 contributors for this article] (2021). Adherence to self-managed exercises for patients with persistent subacromial pain: The Ad-Shoulder feasibility study. Pilot and Feasibility Studies. 7(1). doi: 10.1186/s40814-021-00767-6. Full text in Research Archive Show summary

  Background Exercise is recommended for patients with subacromial pain. It has been suggested that good exercise adherence improves clinical outcomes. Despite this, little attention has been paid to the need for behavioural frameworks to enhance adherence to home exercise programmes for patients with subacromial pain. Methods A feasibility study with pre-post design was used. Participants aged > 18 years, with subacromial pain, who had received conservative treatment during the past 6 months, were recruited. The Ad-Shoulder intervention consisted of 1–5 individual sessions provided over 3 months and was based on 5 self-management skills, which aimed to enhance the patients’ self-efficacy and adherence to self-managed exercises. The primary objectives were assessed according to predefined progression criteria: (1) the recruitment rate (10 patients enrolled within 12 weeks), (2) follow-up rate (≥ 80% on all self-reported measures), (3) objective physical activity measures (≥ 80% of participants would contribute valid data at each time point), (4) adherence with the self-managed exercises (≥ 80% of the participants would adhere to ≥ 80% of the assigned home exercise programme), (5) fidelity of the delivery of the intervention (the therapists delivered the intervention according to the protocol) and (6) adverse events (< 30% would report adverse events (including mild)). The results were reported using descriptive statistics. Results Eleven patients were recruited during 16 weeks. Ten patients completed the self-reported measures at baseline and week 12. Objective physical activity measures were successfully obtained for 100% (11/11) at baseline, 64% (7/11) at week six and 82% at week 12. Fifty-five percent (6/11) of the participants satisfactorily completed at least 80% of their home exercise programme. All sessions were delivered according to the protocol. None of the patients reported any adverse events. Conclusions Objective physical activity data measures at baseline and week 12, follow-up, the physiotherapists’ fidelity to the intervention and adverse events met our pre-specified progression criteria. Recruitment and adherence to the self-managed exercise programme were both below the anticipated level. Further intervention development is necessary to understand whether adherence to the self-managed exercises could be enhanced and additional methods of recruitment would need to be considered, including additional recruitment sites, in any planning for a future main trial.

• Skare, Øystein; Brox, Jostein Skranes; Schrøder, Cecilie Piene & Brox, Jens Ivar (2021). Responsiveness of five shoulder outcome measures at follow-ups from 3 to 24 months. BMC Musculoskeletal Disorders. 22(1), p. 1–10. doi: 10.1186/s12891-021-04483-3. Full text in Research Archive Show summary

  Background To assess responsiveness of five outcome measures at four different follow-ups in patients with SLAP II lesions of the shoulder. Methods 119 patients with symptoms and signs, MRI arthrography and arthroscopic findings were included. The Western Ontario Shoulder Instability Index (WOSI), Oxford Instability Shoulder Score (OISS), EuroQol (EQ-5D3L), Rowe Score and Constant-Murley Score (CMS) were assessed at baseline, 3, 6, 12 and 24 months. The analysis contains both anchor-based and distribution-based methods, and hypothesis testing. Results Confidence intervals for ROC cut-off values, representing MID, for OISS, CMS and EQ-5D3L crossed zero at 3 months. Cut-off values were stable between 6- and 24-months follow-up. At 24-months ROC cut-off values (95% CI) were: Rowe 18 (13 to 24); WOSI 331 (289 to 442); OISS 9 (5 to 14); CMS 11 (9 to 15) and EQ-5D3L 0.123 (0.035 to 0.222). MID95%limit estimates were substantially higher than ROC cut-off values and MIDMEAN at all follow-ups for all instruments. The reliable change proportion (RCP) values in the improved group were highest for WOSI and the Rowe Score (ranging from 68 to 87%) and significantly lower for CMS. EQ-5D3L had the lowest values (13 to 16%). We found a moderate correlation between mean change scores of the outcome measures and the anchor, except for the EQ-5D3L. Conclusions In patients with SLAP II-lesions the patient reported OISS and WOSI and the clinical Rowe score had best responsiveness. Our results suggest that 3 months follow-up is too early for outcome evaluation.

• Grotle, Margreth; Bråten, Lars Christian Haugli; Brox, Jens Ivar; Espeland, Ansgar; Zolic-Karlsson, Zinajda & Killingmo, Rikke Munk [Show all 14 contributors for this article] (2020). Cost–utility analysis of antibiotic treatment in patients with chronic low back pain and Modic changes: results from a randomised, placebo-controlled trial in Norway (the AIM study). BMJ Open. 10(6), p. 1–10. doi: 10.1136/bmjopen-2019-035461. Full text in Research Archive Show summary

  Objective To evaluate the cost–utility of 100 days of antibiotics in patients with chronic low back pain (LBP) and type I or II Modic changes included in the Antibiotic treatment In patients with chronic low back pain and Modic changes (AIM) study. Design A cost–utility analysis from a societal and healthcare perspective alongside a double-blinded, parallel group, placebo, multicentre trial. Setting Hospital outpatient clinics at six hospitals in Norway. The main results from the AIM study showed a small effect in back-related disability in favour of the antibiotics group, and slightly larger in those with type I Modic changes, but this effect was below the pre-defined threshold for clinically relevant effect. Participants 180 patients with chronic LBP, previous disc herniation and Modic changes type I (n=118) or type II (n=62) were randomised to antibiotic treatment (n=89) or placebo-control (n=91). Interventions Oral treatment with either 750 mg amoxicillin or placebo three times daily for 100 days. Main outcome measures Quality-adjusted life years (QALYs) by EuroQoL-5D over 12 months and costs for healthcare and productivity loss measured in Euro (€1=NOK 10), in the intention-to-treat population. Cost–utility was expressed in incremental cost-effectiveness ratio (ICER). Results Mean (SD) total cost was €21 046 (20 105) in the amoxicillin group and €19 076 (19 356) in the placebo group, mean difference €1970 (95% CI; −3835 to 7774). Cost per QALY gained was €24 625. In those with type I Modic changes, the amoxicillin group had higher healthcare consumption than the placebo group, resulting in €39 425 per QALY gained. Given these ICERs and a willingness-to-pay threshold of €27 500 (NOK 275 000), the probability of amoxicillin being cost-effective was 51%. Even when the willingness-to-pay threshold increased to €55 000, the probability of amoxicillin being cost-effective was never higher than 53%. Conclusions Amoxicillin treatment showed no evidence of being cost-effective for people with chronic LBP and Modic changes during 1-year follow-up.

• Olsen, Unni Solveig Johansen; Lindberg, Maren Falch; Denison, Eva Marie-Louise; Rose, Christopher James; Gay, Caryl & Aamodt, Arild [Show all 11 contributors for this article] (2020). Predictors of chronic pain and level of physical function in total knee arthroplasty: a protocol for a systematic review and meta-analysis. BMJ Open. 10, p. 1–9. doi: 10.1136/bmjopen-2020-037674. Full text in Research Archive Show summary

  Abstract Introduction One in five patients undergoing total knee arthroplasty (TKA) experience unchanged or worse pain and physical function 1 year after surgery. Identifying risk factors for unfavourable outcomes is necessary to develop tailored interventions to minimise risk. There is a need to review more current literature with updated methodology that addresses the limitations of earlier systematic reviews and meta-analyses. We present a Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols compliant protocol for a systematic review and meta-analysis of predictors of chronic pain and impaired function after TKA. Methods and analysis This review will include prospective longitudinal observational studies, or randomised trials (including cluster and crossover designs) that report arm-wise predictors of chronic postsurgical pain or impaired physical function at 3 months, 6 months or 12 months. A comprehensive literature search of studies published between 2000 and 2019 will be performed in Medline, Embase, CINAHL, Cochrane Library and PEDro. Blinded assessment with consensus agreement will be applied for inclusion of studies, data extraction and assessment of bias risk (Quality in Prognosis Studies tool). The co-primary outcomes, pain and impaired function, at 12 months after TKA will be analysed separately. Estimates of association between each outcome and any preoperative or intraoperative factor that may predict chronic pain or impaired physical function will be extracted from the included studies, where possible. For randomised studies, results will only be extracted from TKA arms (or the first period of crossover trials). Estimates of association from the primary evidence will be synthesised narratively, and quantitatively using multivariate meta-analysis to provide ‘pooled’ estimates of association. Subgroup and sensitivity analyses will be performed. Certainty of evidence for each predictor will be derived from the Grading of Recommendations Assessment, Development and Evaluation framework. Ethics and dissemination No ethical issues are associated with this project. The results from this review will be published in peer-reviewed journals and presented at international conferences.

• Bråten, Lars Christian Haugli; Schistad, Ellina Iordanova; Espeland, Ansgar; Kristoffersen, Per M; Haugen, Anne Julsrud & Marchand, Gunn Hege [Show all 15 contributors for this article] (2020). Association of Modic change types and their short tau inversion recovery signals with clinical characteristics : a cross sectional study of chronic low back pain patients in the AIM-study. BMC Musculoskeletal Disorders. 21. doi: 10.1186/s12891-020-03381-4. Full text in Research Archive Show summary

  Background - Modic Changes (MCs, magnetic resonance imaging (MRI) signal changes in the vertebral bone marrow extending from the vertebral endplate) may represent a subgroup of nonspecific chronic low back pain that could benefit from a specific management. The primary aim was to compare clinical characteristics between patients with type 1 versus type 2 MCs. The secondary aim was to explore associations between clinical characteristics and MC related short tau inversion recovery (STIR) signals. Methods - This cross-sectional study used baseline data prospectively collected between 2015 and 2017 on the 180 patients included in the AIM-study (Antibiotics In Modic changes), a randomized controlled trial in a Norwegian hospital out-patient setting of patients with chronic low back pain, a lumbar disc herniation within the last 2 years, low back pain intensity score ≥ 5 (on a 0–10 scale) and current type 1 or type 2 MCs at the previously herniated lumbar disc level. We used prespecified clinical characteristics including self-report measures, physiologic measures and functional measures from clinical history and examination. The diagnostic accuracy of various clinical characteristics to discriminate between patients with type 1 MCs (with or without additional type 2 MCs) and patents with type 2 MCs only (not type 1) were assessed by calculating the area under the receiver-operating curve. We assessed the correlations of clinical characteristics with details of MC related STIR signal increase. Results - No clinical characteristic differed between patients with type 1 (n = 118) versus type 2 (but not type 1) (n = 62) MCs. The clinical characteristics showed no/minor differences or no/weak correlations with MC related STIR signal increase. Patients with a positive Springing test (at any lumbar level) had slightly less volume of STIR signal increase than those with a negative test (mean difference 1.3 on a 0–48 scale, 95% CI 0.3 to 2.3). Conclusion - Clinical characteristics were similar for patients with type 1 MCs and patients with type 2 MCs, and showed no clinically relevant correlations with MC related STIR signal increase.

• Bråten, Lars Christian Haugli; Grøvle, Lars; Espeland, Ansgar; Pripp, Are Hugo; Grotle, Margreth & Hellum, Christian [Show all 18 contributors for this article] (2020). Clinical effect modifiers of antibiotic treatment in patients with chronic low back pain and Modic changes - Secondary analyses of a randomised, placebo-controlled trial (the AIM study). BMC Musculoskeletal Disorders. 21, p. 1–11. doi: 10.1186/s12891-020-03422-y. Full text in Research Archive Show summary

  Background: Randomised trials on antibiotic treatment for patients with chronic low back pain and vertebral endplate changes visible on MRI (Modic changes) have shown mixed results. A possible explanation might be a real treatment effect in subgroups of the study populations. The purpose of the present study was to explore potential clinical effect modifiers of 3-months oral amoxicillin treatment in patients with chronic low back pain and type I or II Modic changes at the level of a previous lumbar disc herniation. Methods: We performed analyses of effect modifiers on data from AIM, a double-blind parallel-group multicentre trial. One hundred eighty patients with chronic low back pain, previous disc herniation, Modic change type I (n = 118) or type II (n = 62) were randomised to 3-months oral treatment with 750 mg amoxicillin (n = 89) or placebo (n = 91) three times daily. The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ) score (possible values 0–24) at 1-year follow-up in the intention-to-treat population. The predefined minimal clinically important between-group mean difference was 4 RMDQ points (not reached in the primary analysis of AIM). Predefined baseline characteristics were analysed as potential effect modifiers, four primary (type I Modic changes, previous disc surgery, positive pain provocation test, high CRP) and five exploratory (disturbed sleep, constant low back pain, short duration of low back pain, younger age, and male) using ANCOVA with interaction terms. Results: None of the four primary potential effect modifiers had strong evidence of modifying the treatment effect. In patients younger than 40 years the difference in mean RMDQ score between the treatment groups was − 4.0 (95%CI, − 6.9 to − 1.2), compared to − 0.5 (95%CI, − 2.3 to 1.3) in patients 40 years or older, both in favour of amoxicillin treatment (exploratory analysis). Conclusions: We did not find evidence for convincing clinical effect modifiers of antibiotic treatment in patients with chronic low back pain and Modic changes. Our results for younger age in these explorative analyses should not affect clinical treatment decisions without confirmation in future studies.

• Austevoll, Ivar Magne; Gjestad, Rolf; Solberg, Tore; Storheim, Kjersti; Brox, Jens Ivar & Hermansen, Erland [Show all 9 contributors for this article] (2020). Comparative effectiveness of microdecompression alone vs decompression plus instrumented fusion in lumbar degenerative spondylolisthesis. JAMA Network Open. 3:e2015015(9), p. 1–13. doi: 10.1001/jamanetworkopen.2020.15015. Full text in Research Archive Show summary

  Importance Conflicting evidence and large practice variation are present in the surgical treatment of degenerative spondylolisthesis. More than 90% of surgical procedures in the United States include instrumented fusion compared with 50% or less in other countries. Objective To evaluate whether the effectiveness of microdecompression alone is noninferior to decompression with instrumented fusion in a real-world setting. Design, Setting, and Participants This multicenter comparative effectiveness study with a noninferiority design assessed prospective data from the Norwegian Registry for Spine Surgery. From September 19, 2007, to December 21, 2015, 1376 patients at 35 Norwegian orthopedic and neurosurgical departments underwent surgery for lumbar spinal stenosis with degenerative spondylolisthesis without scoliosis. After excluding patients undergoing laminectomy alone, fusion without instrumentation, or surgery in more than 2 levels and those with a former operation at the index level, 794 patients were included in the analyses, regardless of missing or incomplete follow-up data, before propensity score matching. Data were analyzed from March 20 to October 30, 2018. Exposures Microdecompression alone or decompression with instrumented fusion. Main Outcomes and Measures A reduction from baseline of 30% or greater in the Oswestry Disability Index at 12-month follow-up. Results After propensity score matching, 570 patients (413 female [72%]; mean [SD] age, 64.7 [9.5] years) were included for comparison, with 285 undergoing microdecompression (mean [SD] age, 64.6 [9.8] years; 205 female [72%]) and 285 undergoing decompression with instrumented fusion (mean [SD] age, 64.8 [9.2] years; 208 female [73%]). The proportion of each type of procedure varied between departments. However, changes in outcome scores varied within patients but not between departments. The proportion of patients with improvement in the Oswestry Disability Index of at least 30% was 150 of 219 (68%) in the microdecompression group and 155 of 215 (72%) in the instrumentation group. The 95% CI (–12% to 5%) for the difference of −4% was above the predefined margin of noninferiority (–15%). Microdecompression alone was associated with shorter operation time (mean [SD], 89 [44] vs 180 [65] minutes; P < .001) and shorter hospital stay (mean [SD], 2.5 [2.4] vs 6.4 [3.0] days; P < .001). Conclusions and Relevance Among patients with degenerative spondylolisthesis, the clinical effectiveness of microdecompression alone was noninferior to that of decompression with instrumented fusion. Microdecompression alone was also associated with shorter durations of surgery and hospital stay, supporting the suggestion that the less invasive procedure should be considered for most patients.

• Gjefsen, Elisabeth; Bråten, Lars Christian Haugli; Goll, Guro Løvik; Wigemyr, Monica; Bolstad, Nils & Valberg, Morten [Show all 27 contributors for this article] (2020). The effect of infliximab in patients with chronic low back pain and Modic changes (the BackToBasic study): study protocol of a randomized, double blind, placebo-controlled, multicenter trial. BMC Musculoskeletal Disorders. 21:698, p. 1–14. doi: 10.1186/s12891-020-03720-5. Full text in Research Archive Show summary

  Low back pain is common and a significant number of patients experience chronic low back pain. Current treatment options offer small to moderate effects. Patients with vertebral bone marrow lesions visualized as Modic changes on magnetic resonance imaging may represent a subgroup within the low back pain population. There is evidence for inflammatory mediators being involved in development of Modic changes; hence, suppression of inflammation could be a treatment strategy for these patients. This study examines the effect of anti-inflammatory treatment with the TNF-α inhibitor infliximab in patients with chronic low back pain and Modic changes.Methods/design: The BackToBasic trial is a multicenter, double blind, randomized controlled trial conducted at six hospitals in Norway, comparing intravenous infusions with infliximab with placebo. One hundred twenty-six patients aged 18–65 with chronic low back pain and type 1 Modic changes will be recruited from secondary care outpatients’ clinics. The primary outcome is back pain-specific disability at day 154 (5 months). The study is designed to detect a difference in change of 10 (SD 18) in the Oswestry Disability Index at day 154/ 5 months. The study also aims to refine MRI-assessment, investigate safety and cost-effectiveness and explore the underlying biological mechanisms of Modic changes..Discussion: Finding treatments that target underlying mechanisms could pose new treatment options for patients with low back pain. Suppression of inflammation could be a treatment strategy for patients with low back pain and Modic changes. This paper presents the design of the BackToBasic study, where we will assess the effect of an anti-inflammatory treatment versus placebo in patients with chronic low back pain and type 1 Modic changes.

• Heide, Marte; Mørk, Marianne; Røe, Cecilie; Brox, Jens Ivar & Hoksrud, Aasne Fenne (2020). The effectiveness of radial extracorporeal shock wave therapy (rESWT), sham-rESWT, standardized exercise program or usual care for patients with plantar fasciopathy: study protocol for a double-blind, randomized, sham-controlled trial. Trials. 21. doi: 10.1186/s13063-020-04510-z. Full text in Research Archive Show summary

  Background Plantar fasciopathy is a common cause of plantar heel pain, with a reported prevalence of up to 10%. The choice of best practice in these patients is debated. Two randomised studies reported that radial extracorporeal shock wave therapy is effective, but a meta-analysis concluded that due to methodological limitations, the evidence is questionable. There are few studies reporting the effect of exercise programs with high-load strength training, despite widespread use. The objective of this placebo-controlled, observer-blinded and partly patient blinded trial is to compare rESWT, sham-rESWT, standardised exercise programme and usual care for alleviating heel pain at 6 and 12 months follow-up. Methods/design A double-blind, randomised, sham-controlled trial is conducted at a hospital outpatient clinic of physical medicine and rehabilitation. Patients with chronic (> 3 months) pain due to plantar fasciopathy, aged 18 to 70 years old, are eligible for inclusion in the trial. Patients will be randomly allocated in 1:1 ratio to receive rESWT, sham-rESWT, standardised exercises or usual care. The sample size is estimated to 200 patients, 50 in each group. rESWT or sham-rESWT will be given once a week for 3 weeks. A physiotherapist will supervise the exercises, with a total of 8 sessions over 12 weeks. The patients in the usual care group will receive information, advice and foot orthosis only. All patients, regardless of group, will receive the same information and get an individual customised foot orthosis made by an orthopaedic technician. The primary outcome measure is heel pain intensity during activity in the last week, using a numeric rating scale (NRS, 0 to 10) at the 6 months follow-up adjusted for baseline pain intensity. The secondary outcomes are at the 6- and 12-month follow-up and include Foot Functional Index Revised Short Version (FFI-RS), Patient Global Impression of Change Scale (7-point Likert scale), RAND-12 Health Status Inventory (RAND-12), NRS during rest and NRS during activity (12 months). The patients receiving rESWT/sham-rESWT and the outcome assessor will be blinded to the group assignment. Discussion This trial is designed in order to provide results important for future clinical practice. Trial registration ClinicalTrials.gov NCT03472989 . Registered on 14 March 2018

• Taso, Mirad; Sommernes, Jon Håvard; Kolstad, Frode; Sundseth, Jarle Østberg; Bjorland, Siri & Pripp, Are Hugo [Show all 8 contributors for this article] (2020). A randomised controlled trial comparing the effectiveness of surgical and nonsurgical treatment for cervical radiculopathy. BMC Musculoskeletal Disorders. 21(1), p. 1–9. doi: 10.1186/s12891-020-3188-6. Full text in Research Archive Show summary

  Background Cervical radiculopathy is usually caused by disc herniation or spondylosis. The prognosis is expected to be good in most patients, but there is limited scientific evidence on the indications for nonsurgical and surgical treatments. The aim of the present study is to evaluate and compare the effectiveness of surgical and nonsurgical treatment in two trials – including disc herniation and spondylosis, respectively, and to evaluate factors that contribute to better decision making. Methods/design Patients with disabling radicular arm pain and MRI-proven cervical disc herniation or spondylosis will be randomised to receive nonsurgical or surgical treatment. The follow-up period is one year and the sample size is estimated to be 50 for each arm in the two trials, giving a total of 200 patients. The primary outcomes are the Neck Disability Index and arm pain. Secondary outcomes include neck pain; EQ-5D and costs to evaluate cost-effectiveness; prognostic factors; CT and MRI scans, to estimate intervertebral foraminal area and nerve root compression; and the expected minimal improvement for willingness to undergo treatment. Discussion The outcomes of this study will contribute to better decision making in the treatment of cervical radiculopathy. Trial registration This study has been registered at ClinicalTrials.gov as NCT03674619, on September 17, 2018.

• Furunes, Håvard; Berg, Linda; Espeland, Ansgar; Thoresen, Hanne; Neckelmann, Gesche F & Brøgger, Helga Maria [Show all 10 contributors for this article] (2020). Facet arthropathy following disc replacement versus rehabilitation: A prospective study with 8-year follow-up. Spine. ISSN 0362-2436. 45(21), p. 1467–1475. doi: 10.1097/BRS.0000000000003600. Full text in Research Archive Show summary

  Study design: A prospective study of patients originally randomized to total disc replacement (TDR) or multidisciplinary rehabilitation. Objective: To assess the long-term development of facet arthropathy (FA) after TDR versus nonoperative treatment, and to analyze the association between FA and clinical outcome. Summary of background data: FA may appear or increase following TDR, but the natural course of FA is unclear, and no previous study has evaluated the long-term development of FA following TDR compared with nonoperative treatment. Methods: The study included 126 patients with chronic low back pain and degenerative changes in the lumbar intervertebral discs. The patients underwent pretreatment and 8-year follow-up magnetic resonance imaging (MRI) and 8-year follow-up computed tomography (CT) of the lumbar spine. The primary outcome measure was FA development (yes/no) on MRI at index level L4/L5 or L5/S1, defined as increased FA grade value from pretreatment to follow-up according to Weishaupt grading system. Secondary outcomes included the association between FA (on MRI and CT) and Oswestry Disability Index (ODI) or back pain as well as reoperations. Results: Increased index level FA grade was more frequent after TDR versus nonoperative treatment (36%, 25/69 vs. 2%, 1/57 of patients, P < 0.001), but was not related to change in ODI or back pain. At follow-up, index level FA grades were higher after TDR versus nonoperative treatment (odds ratio 4.0 MRI and 5.9 CT), but were not related to ODI less than or equal to 22. Four patients (6%) treated with TDR and no patients treated nonoperatively were operated for lateral recess stenosis with posterior decompression at the index level during follow-up. Conclusion: Index level FA development was more likely after TDR compared with nonoperative treatment but was not associated with the 8-year clinical outcome. Index level FA may have contributed to reoperations in the TDR group. Level of evidence: 2.

• Skjaker, Stein Arve; Enger, Martine; Engebretsen, Lars; Brox, Jens Ivar & Bøe, Berte Marie Grimsmo (2020). Young men in sports are at highest risk of acromioclavicular joint injuries: a prospective cohort study. Knee Surgery, Sports Traumatology, Arthroscopy. ISSN 0942-2056. doi: 10.1007/s00167-020-05958-x. Full text in Research Archive Show summary

  Purpose To study the incidence of acromioclavicular joint injuries in a general population. Methods All acute shoulder injuries admitted to an orthopaedic emergency department were registered prospectively, using electronic patient records and a patient-reported questionnaire. The regional area was the city of Oslo with 632,990 inhabitants. Patients with symptoms from the acromioclavicular joint without fracture were registered as a dislocation (type II–VI) if the radiologist described widening of the joint space or coracoclavicular distance on standard anteroposterior radiographs. Patients without such findings were diagnosed as sprains (type I). Results Acromioclavicular joint injuries constituted 11% of all shoulder injuries (287 of 2650). The incidence was 45 per 105 person-years (95% confidence interval [CI] 40–51). 196 (68%) were diagnosed as sprains and 91 (32%) as dislocations. Median age of all acromioclavicular joint injuries was 32 years (interquartile range 24–44), and 82% were men. Thirty percent of all acromioclavicular joint injuries were registered in men in their twenties. Sports injuries accounted for 53%, compared to 27% in other shoulder injuries [OR 3.1 (95% CI 2.4–4.0; p < 0.001)]. The most common sports associated with acromioclavicular joint injuries were football (24%), cycling (16%), martial arts (11%), alpine skiing and snowboarding (both 9%), and ice hockey (6%). Conclusion Our study suggests that in the general population, one in ten shoulder injuries involves the acromioclavicular joint and young men in sports are at highest risk. A prognostic level II cohort study.

• Engebretsen, Kaia B.; Brox, Jens Ivar & Juel, Niels Gunnar (2020). Patients with shoulder pain referred to specialist care; treatment, predictors of pain and disability, emotional distress, main symptoms and sick-leave: a cohort study with a six-months follow-up. Scandinavian Journal of Pain. ISSN 1877-8860. 20(4), p. 775–783. doi: 10.1515/sjpain-2020-0044. Full text in Research Archive
• Hermansen, Erland; Austevoll, Ivar Magne; Hellum, Christian; Storheim, Kjersti; Myklebust, Tor Åge & Aaen, Jørn Ståle [Show all 17 contributors for this article] (2020). Comparable increases in dural sac area after three different posterior decompression techniques for lumbar spinal stenosis: radiological results from a randomized controlled trial in the NORDSTEN study. European spine journal. ISSN 0940-6719. 29, p. 2254–2261. doi: 10.1007/s00586-020-06499-0. Full text in Research Archive Show summary

  Purpose: To investigate changes in dural sac area after three different posterior decompression techniques in patients undergoing surgery for lumbar spinal stenosis. Summary of background data: Decompression of the nerve roots is the main surgical treatment for lumbar spinal stenosis. The aim of this study was to radiologically investigate three commonly used posterior decompression techniques. Methods: The present study reports data from one of two multicenter randomized trials included in the NORDSTEN study. In the present trial, involving 437 patients undergoing surgery, we report radiological results after three different midline retaining posterior decompression techniques: unilateral laminotomy with crossover (UL) (n = 146), bilateral laminotomy (BL) (n = 142) and spinous process osteotomy (SPO) (n = 149). MRI was performed before and three months after surgery. The increase in dural sac area and Schizas grade at the most stenotic level was evaluated. Three different predefined surgical indicators of substantial decompression were used: (1) postoperative dural sac area of > 100 mm2, (2) increase in the dural sac area of at least 50% and (3) postoperative Schizas grade A or B. Results: No differences between the three surgical groups were found in the mean increase in dural sac area. Mean values were 66.0 (SD 41.5) mm2 in the UL-group, 71.9 (SD 37.1) mm2 in the BL-group and 68.1 (SD 41.0) mm2 in the SPO-group (p = 0.49). No differences in the three predefined surgical outcomes between the three groups were found. Conclusion: For patients with lumbar spinal stenosis, the three different surgical techniques provided the same increase in dural sac area.

• Steen, Harald; Pripp, Are Hugo; Lange, Johan Emil & Brox, Jens Ivar (2020). Predictors for long-term curve progression after Boston brace treatment of idiopathic scoliosis. European Journal of Physical and Rehabilitation Medicine. ISSN 1973-9087. p. 1–25. doi: 10.23736/S1973-9087.20.06190-0. Full text in Research Archive Show summary

  BACKGROUND: Identifying factors that predict successful bracing in patients with idiopathic scoliosis may help planning treatment. AIM: To assess predictors for long-term curve progression and health-related quality of life after Boston brace treatment. DESIGN: Observational retrospective cohort study with analysis of brace treated patients followed from start until at least 10 years after treatment. SETTING: Patients recruited from the country´s entire population consecutively treated at the National Hospital. POPULATION: 365 patients (339 girls/26 boys) with idiopathic scoliosis. Mean (SD) chronological age/bone age at start bracing was 13.2 (1.9)/12.6 (1.9) years. The primary major curve measured 33.2 (7.4)°, and the major levels were thoracic (n=248), thoracolumbar (n=78) and lumbar (n=39). Mean bracing time was 2.8 (1.5) years. Long-term follow-up was in average 23.3 (4.1) years after weaning with a mean major curve of 33.0 (13.1)°. OUTCOME MEASURES: Successful treatment was defined as a stable primary curve with progression ≤5°, and secondary the SRS-22 questionnaire assessed quality of life. METHODS: We applied linear or logistic regression with backward elimination. Internal validation was assessed by bootstrapping. 12 variables were included in the prediction models: age, bone age, scoliosis in close family, major curve size, level, shape, flexibility and in-brace redressement, compliance, curve magnitude after 1 year, treatment time and quality of life (SRS-22). The study was funded by an institutional grant. No authors had any conflicts of interest. RESULTS: 290 patients (79%) had rated good compliance using the brace >20 hours daily. Treatment failure was observed in 65 patients (18%), and 27 of them were operated. The best baseline predictors were age and brace redressement. During treatment compliance, major curve after 1 year, and treatment time were the best predictors, while thoracic major curve, curve size at start bracing and scoliosis in close family also contributed to the final model. The model’s ability to predict quality of life was low. CONCLUSIONS: The best predictors for a long-term success were good redressement and compliance, unchanged or reduced major curve after one year and short treatment time. CLINICAL REHABILITATION IMPACT: Predictors at baseline and during early treatment can help identifying patients who benefit from bracing.

• Brox, Jens Ivar; Skare, Øystein; Mowinckel, Petter; Brox, Jostein Skranes; Reikerås, Olav & Schrøder, Cecilie Piene (2020). Sick leave and return to work after surgery for type II SLAP lesions of the shoulder: a secondary analysis of a randomized sham-controlled study. BMJ Open. 10(4), p. 1–9. doi: 10.1136/bmjopen-2019-035259. Full text in Research Archive Show summary

  Objectives To compare days on sick leave and assess predictors of return to work following shoulder surgery. Design A secondary analysis of a randomised controlled trial. Setting Orthopaedic department. Participants 114 patients with type II superior labral tear from anterior to posterior of the shoulder. Interventions Labral repair, biceps tenodesis or sham surgery. Outcome measures Sick leave was obtained from national registers for the last year before and 2 years following surgery. Total and shoulder related number of days on sick leave were obtained, using international diagnostic codes. We applied the difference-in-difference approach to compare the differences in the change in mean work days on sick leave between groups over time, backwards logistic regression and lasso regression to evaluate predictors. Results Mean total number of work days on sick leave during the 2 years after surgery was 148 (range 0–460) days. More than 80% of the sick leave days were taken by 22% of the patients. Days on sick leave classified as shoulder-related constituted 80% of the total. In all three treatment groups, the mean total number of days on sick leave doubled the year after surgery. Sham surgery and labral repair had fewer postoperative sickness absence days compared with biceps tenodesis but differences were not significant when adjusted for days of sick leave the year before surgery. Predictors of return to work at 2 years analysed by logistic regression were no sick leave (OR 8.0, 95% CI 2.4 to 26.0) and moderate symptoms of anxiety or depression (OR 0.16, 95% CI 0.05 to 0.5) at inclusion. Similar results were obtained by lasso regression but manual work was an additional predictor. Conclusions Change in mean work days on sick leave comparing sham surgery, labral repair and biceps tenodesis, was not significantly different. Sick leave, symptoms of anxiety and depression, and manual work at inclusion predicted work status 2 years after surgery.

• Bråten, Lars Christian Haugli; Rolfsen, Mads Peder; Espeland, Ansgar; Wigemyr, Monica; Assmus, Jörg & Froholdt, Anne [Show all 28 contributors for this article] (2019). Efficacy of antibiotic treatment in patients with chronic low back pain and Modic changes (the AIM study): double blind, randomised, placebo controlled, multicentre trial. The BMJ. 367. doi: 10.1136/bmj.l5654. Full text in Research Archive Show summary

  Objective To assess the efficacy of three months of antibiotic treatment compared with placebo in patients with chronic low back pain, previous disc herniation, and vertebral endplate changes (Modic changes). Design Double blind, parallel group, placebo controlled, multicentre trial. Setting Hospital outpatient clinics at six hospitals in Norway. Participants 180 patients with chronic low back pain, previous disc herniation, and type 1 (n=118) or type 2 (n=62) Modic changes enrolled from June 2015 to September 2017. Interventions Patients were randomised to three months of oral treatment with either 750 mg amoxicillin or placebo three times daily. The allocation sequence was concealed by using a computer generated number on the prescription. Main outcome measures The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ) score (range 0-24) at one year follow-up in the intention to treat population. The minimal clinically important between group difference in mean RMDQ score was predefined as 4. Results In the primary analysis of the total cohort at one year, the difference in the mean RMDQ score between the amoxicillin group and the placebo group was −1.6 (95% confidence interval −3.1 to 0.0, P=0.04). In the secondary analysis, the difference in the mean RMDQ score between the groups was −2.3 (−4.2 to−0.4, P=0.02) for patients with type 1 Modic changes and −0.1 (−2.7 to 2.6, P=0.95) for patients with type 2 Modic changes. Fifty patients (56%) in the amoxicillin group experienced at least one drug related adverse event compared with 31 (34%) in the placebo group. Conclusions In this study on patients with chronic low back pain and Modic changes at the level of a previous disc herniation, three months of treatment with amoxicillin did not provide a clinically important benefit compared with placebo. Secondary analyses and sensitivity analyses supported this finding. Therefore, our results do not support the use of antibiotic treatment for chronic low back pain and Modic changes.

• Hott, Alexandra Christine; Brox, Jens Ivar; Pripp, Are Hugo; Juel, Niels Gunnar & Liavaag, Sigurd (2019). Predictors of Pain, Function, and Change in Patellofemoral Pain. American Journal of Sports Medicine. ISSN 0363-5465. 48(2), p. 351–358. doi: 10.1177/0363546519889623. Full text in Research Archive
• Austevoll, Ivar Magne; Hermansen, Erland; Fagerland, Morten; Rekeland, Frode; Solberg, Tore & Storheim, Kjersti [Show all 12 contributors for this article] (2019). Decompression alone versus decompression with instrumental fusion the NORDSTEN degenerative spondylolisthesis trial (NORDSTEN-DS); study protocol for a randomized controlled trial. BMC Musculoskeletal Disorders. 20:7, p. 1–10. doi: 10.1186/s12891-018-2384-0. Full text in Research Archive Show summary

  Background: Fusion in addition to decompression has become the standard treatment for lumbar spinal stenosis with degenerative spondylolisthesis (DS). The evidence for performing fusion among these patients is conflicting and there is a need for further investigation through studies of high quality. The present protocol describes an ongoing study with the primary aim of comparing the outcome between decompression alone and decompression with instrumented fusion. The secondary aim is to investigate whether predictors can be used to choose the best treatment for an individual. The trial, named the NORDSTEN-DS trial, is one of three studies in the Norwegian Degenerative Spinal Stenosis (NORDSTEN) study. Methods: The NORDSTEN-DS trial is a block-randomized, controlled, multicenter, non-inferiority study with two parallel groups. The surgeons at the 15 participating hospitals decide whether a patient is eligible or not according to the inclusion and exclusion criteria. Participating patients are randomized to either a midline preserving decompression or a decompression followed by an instrumental fusion. Primary endpoint is the percentage of patients with an improvement in Oswestry Disability Index version 2.0 of more than 30% from baseline to 2-year follow-up. Secondary outcome measurements are the Zürich Claudication Questionnaire, Numeric Rating Scale for back and leg pain, Euroqol 5 dimensions questionnaire, Global perceived effect scale, complications and several radiological parameters. Analysis and interpretation of results will also be conducted after 5 and 10years. Conclusion: The NORDSTEN/DS trial has the potential to provide Level 1 evidence of whether decompression alone should be advocated as the preferred method or not. Further on the study will investigate whether predictors exist and if they can be used to make the appropriate choice for surgical treatment for this patient group. Trial registration: ClinicalTrials.gov Identifier: NCT02051374. First Posted: January 31, 2014. Last Update Posted: February 14, 2018.

• Hermansen, Erland; Myklebust, Tor Åge; Austevoll, Ivar Magne; Rekeland, Frode; Solberg, Tore & Storheim, Kjersti [Show all 11 contributors for this article] (2019). Clinical outcome after surgery for lumbar spinal stenosis in patients with insignificant lower extremity pain. A prospective cohort study from the Norwegian registry for spine surgery. BMC Musculoskeletal Disorders. 20:36, p. 1–8. doi: 10.1186/s12891-019-2407-5. Full text in Research Archive Show summary

  Background: Spinal stenosis is a clinical diagnosis in which the main symptom is pain radiating to the lower extremities, or neurogenic claudication. Radiological spinal stenosis is commonly observed in the population and it is debated whether patients with no lower extremity pain should be labelled as having spinal stenosis. However, these patients is found in the Norwegian Registry for Spine Surgery, the main object of the present study was to compare the clinical outcomes after decompressive surgery in patients with insignificant lower extremity pain, with those with more severe pain. Methods: This study is based on data from the Norwegian Registry for Spine Surgery (NORspine). Patients who had decompressive surgery in the period from 7/1–2007 to 11/3–2013 at 31 hospitals were included. The patients was divided into four groups based on preoperative Numeric Rating Scale (NRS)-score for lower extremity pain. Patients in group 1 had insignificant pain, group 2 had mild or moderate pain, group 3 severe pain and group 4 extremely severe pain. The primary outcome was change in the Oswestry Disability Index (ODI). Successfully treated patients were defined as patients reporting at least 30% reduction of baseline ODI, and the number of successfully treated patients in each group were recorded. Results: In total, 3181 patients were eligible; 154 patients in group 1; 753 in group 2; 1766 in group 3; and 528 in group 4. Group 1 had significantly less improvement from baseline in all the clinical scores 12months after surgery compared to the other groups. However, with a mean reduction of 8 ODI points and 56% of patients showing a reduction of at least 30% in their ODI score, the proportion of patients defined as successfully treated in group 1, was not significantly different from that of other groups. Conclusion: This national register study shows that patients with insignificant lower extremity pain had less improvement in primary and secondary outcome parameters from baseline to follow-up compared to patients with more severe lower extremity pain.

• Vandvik, Per Olav; Lähdeoja, Tuomas; Ardern, Clare; Buchbinder, Rachelle; Moro, Jaydeep & Brox, Jens Ivar [Show all 20 contributors for this article] (2019). Subacromial decompression surgery for adults with shoulder pain: A clinical practice guideline. The BMJ. 364:I294, p. 1–8. doi: 10.1136/bmj.l294. Full text in Research Archive
• Hott, Alexandra Christine; Brox, Jens Ivar; Pripp, Are Hugo; Juel, Niels Gunnar; Paulsen, Gøran & Liavaag, Sigurd (2019). Effectiveness of Isolated Hip Exercise, Knee Exercise, or Free Physical Activity for Patellofemoral Pain: A Randomized Controlled Trial. American Journal of Sports Medicine. ISSN 0363-5465. 47(6), p. 1312–1322. doi: 10.1177/0363546519830644. Full text in Research Archive
• Austevoll, Ivar Magne; Gjestad, Rolf; Grotle, Margreth; Solberg, Tore; Brox, Jens Ivar & Hermansen, Erland [Show all 10 contributors for this article] (2019). Follow-up score, change score or percentage change score for determining clinical important outcome following surgery? An observational study from the Norwegian registry for Spine surgery evaluating patient reported outcome measures in lumbar spinal stenosis and lumbar degenerative spondylolisthesis. BMC Musculoskeletal Disorders. 20:31, p. 1–15. doi: 10.1186/s12891-018-2386-y. Full text in Research Archive Show summary

  Background: Assessment of outcomes for spinal surgeries is challenging, and an ideal measurement that reflects all aspects of importance for the patients does not exist. Oswestry Disability Index (ODI), EuroQol (EQ-5D) and Numeric Rating Scales (NRS) for leg pain and for back pain are commonly used patients reported outcome measurements (PROMs). Reporting the proportion of individuals with an outcome of clinical importance is recommended. Knowledge of the ability of PROMs to identify clearly improved patients is essential. The purpose of this study was to search cut-off criteria for PROMs that best reflect an improvement considered by the patients to be of clinical importance. Methods: The Global Perceived Effect scale was utilized to evaluate a clinically important outcome 12 months after surgery. The cut-offs for the PROMs that most accurately distinguish those who reported ‘completely recovered’ or ‘much improved’ from those who reported ‘slightly improved’, unchanged’, ‘slightly worse’, ‘much worse’, or ‘worse than ever’ were estimated. For each PROM, we evaluated three candidate response parameters: the (raw) follow-up score, the (numerical) change score, and the percentage change score. Results: We analysed 3859 patients with Lumbar Spinal Stenosis [(LSS); mean age 66; female gender 50%] and 617 patients with Lumbar Degenerative Spondylolisthesis [(LDS); mean age 67; 72% female gender]. The accuracy of identifying ‘completely recovered’ and ‘much better’ patients was generally high, but lower for EQ-5D than for the other PROMs. For all PROMs the accuracy was lower for the change score than for the follow-up score and the percentage change score, especially among patients with low and high PROM scores at baseline. The optimal threshold for a clinically important outcome was ≤24 for ODI, ≥0.69 for EQ-5D, ≤3 for NRS leg pain, and ≤ 4 for NRS back pain, and, for the percentage change score, ≥30% for ODI, ≥40% for NRS leg pain, and ≥ 33% for NRS back pain. The estimated cut-offs were similar for LSS and for LDS. Conclusion: For estimating a ‘success’ rate assessed by a PROM, we recommend using the follow-up score or the percentage change score. These scores reflected a clinically important outcome better than the change score.

• Hott, Alexandra Christine; Liavaag, Sigurd; Juel, Niels Gunnar; Brox, Jens Ivar & Ekeberg, Ole Marius (2019). The reliability, validity, interpretability, and responsiveness of the Norwegian version of the Anterior Knee Pain Scale in patellofemoral pain. Disability and Rehabilitation. ISSN 0963-8288. doi: 10.1080/09638288.2019.1671499. Full text in Research Archive
• Søberg, Helene L.; Engebretsen, Kaia Beck; Juel, Niels Gunnar; Røe, Yngve & Brox, Jens Ivar (2019). Associations between shoulder pain and functioning on the ICF Checklist and the Disabilities of the Arm, Shoulder and Hand scale – a cross-sectional study. Disability and Rehabilitation. ISSN 0963-8288. p. 1–8. doi: 10.1080/09638288.2019.1584252. Full text in Research Archive Show summary

  Purpose: The association between patients’ shoulder pain and functioning according to the International Classification of Functioning, Disability, and Health (ICF), and outcome on a condition specific patient reported outcome measure (PROM), has not been studied. The aim was to investigate how the most common problems on the ICF checklist were associated with shoulder function and disability. Materials and methods: In a cross-sectional design 164 patients ≥ 18 years with chronic shoulder pain were included. The ICF checklist, the Disability of the Arm, Shoulder, and Hand (DASH) outcome measure and the Self-Report Comorbidity Questionnaire were used. A hierarchical regression model tested categories for functioning on the ICF checklist associated with disability on the DASH. Results: Mean age was 46.5 years, 54% were women. 85% had had the shoulder pain longer than 6 months. Mean DASH score was 33.2 points (SD 17.1). Adjusted R2 was 0.67. Older age, being woman and having a lower education explained 22% of the variance on the DASH. The body functions bodily pain, mobility of joints and energy and drive function explained 30% of the variance, and the activities and participation problems lifting and carrying objects, washing oneself and recreation and leisure explained an additional 13%. Conclusions: The shoulder disability was multi-dimensional and comprised body functions and activities and participation. And 67% of the variance in the DASH score was explained. Implications for rehabilitation Persistent shoulder pain results in multi-dimensional disability calling for a broader assessment of function. A biopsychosocial approach to shoulder pain and disability is recommended. Functioning assessed on the ICF checklist can be applied in the assessment of chronic shoulder pain as it contributes to the understanding of self-reported disability on a region specific outcome measure.

• Molland, Ragnhild Susanne; Brox, Jens Ivar; Stuge, Britt; Holm, Inger; Riise, Rolf Bjarne & Kibsgård, Thomas (2019). Health related quality of life and physical activity after multiple-surgeries in patients with early onset scoliosis. Spine Deformity. ISSN 2212-134X. 7(6), p. 1010–1010. Full text in Research Archive
• Enger, Martine Merete; Skjaker, Stein Arve; Nordsletten, Lars; Pripp, Are Hugo; Melhuus, Knut & Moosmeyer, Stefan [Show all 7 contributors for this article] (2019). Sports-related acute shoulder injuries in an urban population. BMJ Open sport & exercise medicine. 5(1), p. 1–9. doi: 10.1136/bmjsem-2019-000551. Full text in Research Archive Show summary

  More than a third of sports injuries involve the upper extremity. The primary aim was to quantify and describe sports-related shoulder injuries in a general population cohort. A secondary aim was to compare aspects of these injuries to those that were not sports-related.We performed a prospective registration of the activity at the time of shoulder injury in all cases admitted during 1 year in a combined primary care and orthopaedic emergency department serving a defined population. The electronic patient records and patient reported questionnaires were reviewed.Twenty-nine per cent (n=781) of 2650 registered shoulder injuries were reported to be sports-related, with the highest proportion in acromioclavicular injuries (&gt;50%). Patients with sports injuries were younger than those injured during other activities (median age 28 and 43 years, respectively, p&lt;0.001), and more often male (78% and 52%, respectively, p&lt;0.001). There was a strong gender disparity in incidence of sports-related shoulder injuries in adolescents and young adults, which was not observed in non-sports shoulder injuries. Football (soccer) (6–29 years), cycling (30–49 years), skiing (50–69 years) and martial arts were the dominating sports activities. Fractures were more common in skiing and cycling than in other major sports in the study.Almost a third of the shoulder injuries occurred during sports. The types of sports involved varied with age and gender. The comparison of sport to non-sport shoulder injury incidence rates suggests that the increased risk of shoulder injuries in young males is mainly attributable to sports injuries.

• Hott, Alexandra Christine; Brox, Jens Ivar; Pripp, Are Hugo; Juel, Niels Gunnar & Liavaag, Sigurd (2019). Patellofemoral pain: One year results of a randomized trial comparing hip exercise, knee exercise, or free activity. Scandinavian Journal of Medicine & Science in Sports. ISSN 0905-7188. p. 1–13. doi: 10.1111/sms.13613. Full text in Research Archive
• Aulie, Vibeke Smith; Halvorsen, Vera Baasland & Brox, Jens Ivar (2018). Motor abilities in 182 children treated for idiopathic clubfoot: a comparison between the traditional and the Ponseti method and controls. Journal of Children's Orthopaedics. ISSN 1863-2521. 12(4), p. 383–389. doi: 10.1302/1863-2548.12.170195. Full text in Research Archive
• Holtedahl, Robin; Brox, Jens Ivar; Aune, Arne Kristian; Nguyen, Daniel; Risberg, May Arna & Tjomsland, Ole (2018). Changes in the rate of publicly financed knee arthroscopies: An analysis of data from the Norwegian patient registry from 2012 to 2016. BMJ Open. 8(6), p. 1–6. doi: 10.1136/bmjopen-2017-021199. Full text in Research Archive Show summary

  Objective: To examine rates of publicly financed knee arthroscopic surgery in Norway between 2012 and 2016. Design: Analysis of anonymised data from the National Patient Registry. Interventions: Beginning in 2012, South-Eastern Norway Regional Health Authority implemented administrative measures to bring down rates of knee arthroscopy. Similar measures were not introduced in the other three Regional Health Authorities. Main outcome measures: We analysed annual national rates of publicly financed knee arthroscopies in 2012 and 2016. We compared the rates in South-Eastern Norway Regional Health Authority with corresponding rates in the rest of the country. Variations by county, public hospital versus publicly reimbursed private hospital, gender and age were also assessed. Results: The overall annual rate of arthroscopic procedures declined by 33% from 2012 to 2016, from 310 to 207 per 100 000 inhabitants, respectively. Hospitals in South-Eastern Norway Regional Health Authority reported a 48% reduction, compared with mean 13% in the other three Regional Health Authorities. In public hospitals, rates decreased nationally by 42%, while rates in publicly reimbursed private hospitals increased by 12%. Rates in publicly reimbursed private hospitals decreased by 30% in South-Eastern Norway Regional Health Authority but increased by 63% in the other Regional Health Authorities. The proportion of patients ≥50 years (excluding meniscal repairs) in Norway was 54% in 2012 and fell to 46% in 2016. Average rates per county varied by a factor of 3:1. Conclusion: We report a marked overall reduction of knee arthroscopic procedures from 2012 to 2016 in publicly funded hospitals. The largest decrease was reported in South-Eastern Norway Regional Health Authority, and this coincides in time with implemented administrative measures. The results suggest that the trend of increasing rates of knee arthroscopies can be reversed through purposeful professional and administrative interventions.

• Furunes, Håvard; Hellum, Christian; Espeland, Ansgar; Brox, Jens Ivar; Småstuen, Milada C & Berg, Linda [Show all 7 contributors for this article] (2018). Adjacent disc degeneration after lumbar total disc replacement or non-operative Treatment: A randomized study with eight-year follow-up. Spine. ISSN 0362-2436. 43(24), p. 1695–1703. doi: 10.1097/BRS.0000000000002712. Full text in Research Archive Show summary

  Study Design. A randomized controlled multicenter trial with 8-year follow-up. Objective. The aim of this study was to assess the long-term development of adjacent disc degeneration (ADD) after lumbar total disc replacement (TDR) or nonoperative treatment, and to analyze the association between ADD development and clinical outcome. Summary of Background Data. TDR was introduced as a motion-preserving alternative to spinal fusion, which has been reported to increase the risk of ADD. However, ADD may develop naturally regardless of any surgery, and no randomized study has assessed the long-term development of ADD after TDR versus nonoperative treatment. Methods. The study included 126 of the 173 patients with chronic low back pain (LBP) originally included in a randomized study comparing TDR with multidisciplinary rehabilitation. Magnetic resonance imaging (MRI) of the lumbar spine was performed before treatment and at 8-year follow-up. ADD was categorized as increased or not increased based on an evaluation of Modic changes, disc height reduction, disc contour, herniation size, nucleus pulposus signal, and posterior high intensity zones. We used a χ2 test or a Fisher exact test to compare crude proportions, and multiple linear regressions to analyze the association between increased ADD (yes/no) and change in Oswestry Disability Index (ODI) from pre-treatment to follow-up. Results. ADD increased (for at least one ADD variable) in 23 of 57 patients (40%) treated nonoperatively, and 29 of 69 patients (42%) treated with TDR (P = 0.86). We found no significant associations between ADD increase and the change in ODI. Conclusion. Increased ADD occurred with similar frequency after TDR and after nonoperative treatment, and was not related to the clinical outcome at 8-year follow-up.

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• Aars, Nils Abel; Brandseth, Oda Lekve; Bardal, Ingvild; Stevelink, Sharon; Sanatkar, Samineh & Trichet, Laurent Olivier [Show all 14 contributors for this article] (2025). Cohort profile: the Norwegian Neck and Back Registry (NNRR): a medical quality registry for patients with neck and back complaints. BMJ Open. 15(3). doi: 10.1136/bmjopen-2024-096992. Full text in Research Archive
• Hermansen, Erland; Indrekvam, Kari; Franssen, Eric; Myklebust, Tor Åge; Austevoll, Ivar Magne & Hellum, Christian [Show all 16 contributors for this article] (2025). Correction to: ISSLS Prize in Clinical Science 2025: A randomized trial on three different minimally invasive decompression techniques for lumbar spinal stenosis. Five years follow-up from the NORDSTEN-SST (European Spine Journal, (2024), 10.1007/s00586-024-08514-0). European spine journal. ISSN 0940-6719. 34(5), p. 2044–2045. doi: 10.1007/s00586-024-08561-7. Full text in Research Archive
• Tjomsland, Ole; Bertilsson, Helena Maria; Bjerkan, Geir; Blomquist, Per Jesper Fredrik; Brox, Jens Ivar & Bøe, Berte Marie Grimsmo [Show all 13 contributors for this article] (2025). Protocol for a national intervention programme aimed to reduce unwarranted variation and overuse of shoulder arthroscopy in Norway. doi: 10.1136/bmjoq-2024-003099. Full text in Research Archive
• Werner, Erik Lønnmark & Brox, Jens Ivar (2024). Smertebehandling av ryggpasienter. Tidsskrift for Den norske legeforening (Tidsskriftet). ISSN 0029-2001. 144(2), p. 1–3. doi: 10.4045/tidsskr.24.0031. Full text in Research Archive
• Melås, Thea Morin; Bjørneboe, John Andreas; Juel, Niels Gunnar; Wefring, Maren Lunder; Skatteboe, Sigrid & Killingmo, Rikke Munk [Show all 14 contributors for this article] (2024). Self-management versus usual care for greater trochanteric pain syndrome: protocol for a randomized controlled trial with nested qualitative interviews (the HIPS trial). Full text in Research Archive
• Seip, Andreas Ottersen; Solberg, Tore; Brox, Jens Ivar; Hermansen, Erland; Fagerland, Morten & Weber, Clemens [Show all 14 contributors for this article] (2024). P293. Surgeons’ selection of the right patient for fusion surgery for degenerative spondylolisthesis. The spine journal. ISSN 1529-9430. 24(9), p. S207–S207. doi: 10.1016/j.spinee.2024.06.416. Full text in Research Archive
• Taso, Mirad & Brox, Jens Ivar (2024). Letter to the editor regarding “Patient expectations impact patient-reported outcomes and satisfaction after lumbar fusion” by Zhang et al. The spine journal. ISSN 1529-9430. 24(7), p. 1334–1334. doi: 10.1016/j.spinee.2024.02.025. Full text in Research Archive
• Olsen, Unni; Lindberg, Maren Falch; Rose, Christopher James; Denison, Eva Marie-Louise; Gay, Caryl & Aamodt, Arild [Show all 11 contributors for this article] (2023). BMI, Physical Function And Osteoarthritis Severity Correlate With Physical Function One Year After Total Knee Arthroplasty: A Systematic Review And Meta-Analysis. Full text in Research Archive
• Fors, Egil Andreas; Brox, Jens Ivar; Simula, Anna-Sofia & Andersen, Tor Inge (2022). LOW BACK PAIN: HOW TO MANAGE IN PRIMARY CARE? Full text in Research Archive
• Brox, Jens Ivar (2020). En legeroman. Full text in Research Archive
• Juel, Niels Gunnar; Pedersen, Stein Jarle; Engebretsen, Kaia Beck; Brurberg, Kjetil Gundro; Ekeberg, Ole Marius & Reme, Silje Endresen [Show all 8 contributors for this article] (2019). Atraumatiske skuldersmerter i prim?rhelsetjenesten. 139(7). doi: 10.4045/tidsskr.19.0116. Full text in Research Archive
• Brox, Jens Ivar (2019). The Fear Avoidance Beliefs Questionnaire-the FABQ-for the benefit of another 70 million potential pain patients. Scandinavian Journal of Pain. ISSN 1877-8860. 19(1), p. 1–2. doi: 10.1515/sjpain-2018-2005. Full text in Research Archive
• Juel, Niels Gunnar; Brox, Jens Ivar; Ekeberg, Ole Marius; Brurberg, Kjetil Gundro; Engebretsen, Kaia Beck & Reme, Silje Endresen [Show all 8 contributors for this article] (2018). Norwegian guidelines for shoulder pain in primary care. Full text in Research Archive

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