Responsiveness and minimal important change of specific and generic patient-reported outcome measures for back patients: the Norwegian Neck and Back Register.

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.

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.

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. TRIAL REGISTRATION NUMBER: NCT03472989.

The Norwegian degenerative spondylolisthesis and spinal stenosis (NORDSTEN) study: study overview, organization structure and study population.

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. TRIAL REGISTRATION: ClinicalTrials.gov; NCT02007083 10/12/2013, NCT02051374 31/01/2014 and NCT03562936 20/06/2018.

The Norwegian registry for spine surgery (NORspine): cohort profile.

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.

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.

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).

The clinical impact of retears after repair of posterosuperior rotator cuff tears: a systematic review and meta-analysis.

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.

What is success of treatment? Expected outcome scores in cervical radiculopathy patients were much higher than the previously reported cut-off values for success.

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.

Clinical and MRI findings in lumbar spinal stenosis: baseline data from the NORDSTEN study.

PURPOSE: The aim was to describe magnetic resonance imaging findings in patients planned for lumbar spinal stenosis surgery. Further, to describe possible associations between MRI findings 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 findings were evaluated before surgery: morphological (Schizas) and quantitative (cross-sectional area) grade of stenosis, disk degeneration (Pfirrmann), facet joint tropism and fatty infiltration of the multifidus muscle. Patients were dichotomized into a moderate or severe category for each radiological parameter classification. A multivariable linear regression analysis was performed to investigate the association between MRI findings 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%, Pfirrmann (4 + 5) 58.1%, tropism (≥ 15°) 11.9%, degeneration of multifidus muscle (2-4) 83.7%. Regression coefficients indicated minimal changes in severity of symptoms when comparing the groups with moderate and severe MRI findings. Only gender had a significant and clinically relevant association with ODI score. CONCLUSION: In this cross-sectional study, the majority of the patients had MRI findings classified as severe LSS changes, but the findings 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 findings. TRIAL REGISTRATION: www. CLINICALTRIALS: gov identifier: NCT02007083, registered December 2013.

Reliability of preoperative MRI findings in patients with lumbar spinal stenosis.

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. TRIAL REGISTRATION: www.ClinicalTrials.gov identifier: NCT02007083 , registered December 2013.

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.

PURPOSE: To perform a meta-analysis to explore factors associated with clinical and structural short-term outcomes in randomized and nonrandomized prospective studies of rotator cuff repair. METHODS: Medline, clinicaltrials.gov, and Mendeley were searched for literature published from January 2000 to December 2020 to identify randomized controlled trials (RCT) and nonrandomized prospective cohort studies (PCS) describing the outcome of surgical repair of full-thickness rotator cuff tears. Study quality was assessed by two independent reviewers. We calculated standardized mean difference (SMD) from baseline to follow-up in each trial arm, preferably at 12 months follow-up. Between-study heterogeneity of outcomes, small-study effects and rates of retear were assessed. Meta-regression was performed to estimate associations between prespecified variables and clinical and structural outcomes. RESULTS: Outcomes in 64 RCT and 19 PCS trial arms were analyzed. Median age was 59 years. There was substantial between-study heterogeneity in clinical outcomes (SMD range: .42 to 6.44; I2 = 93% in RCT, 88% in PCS) and summary estimates were not calculated. On the basis of multivariate analysis, better clinical outcome was associated with lower (worse) mean outcome value at baseline, smaller tear size, and lower proportion of large-massive tears (R2 = 56 and 44%, respectively). Overall retear rate at median 13-month follow-up was 19.9% (interquartile range: 10-30). Higher mean age together with larger tear size and higher proportion of large-massive tears were associated with increased retear rates (R2 = 33% and 58%, respectively). Clinical outcome was not significantly related to rate of retear. CONCLUSIONS: Studies with lower mean outcome values at baseline and predominantly small- to medium-sized tears reported better clinical outcomes. Studies with higher mean age and a predominance of large-massive tears had significantly increased retear rates, but retear rates were not associated with clinical outcome. LEVEL OF EVIDENCE: Level II, meta-analysis of level I and II studies.

Responsiveness of five shoulder outcome measures at follow-ups from 3 to 24 months.

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.

Interrater reliability of physical examination tests in the acute phase of shoulder injuries.

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 ).

Young men in sports are at highest risk of acromioclavicular joint injuries: a prospective cohort study.

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.

Patellofemoral pain: One year results of a randomized trial comparing hip exercise, knee exercise, or free activity.

OBJECTIVE: Extended follow-up of a randomized trial comparing hip-focused exercise, knee-focused exercise, and free physical activity in patellofemoral pain (PFP). METHODS: A single-blind randomized controlled trial included 112 patients aged 16-40 years (mean 27.6 years) with a clinical diagnosis of PFP ≥3 months (mean 39 months) and pain ≥3/10 on a Visual Analog Scale. Patients were randomized to a 6-week exercise-based intervention consisting of either isolated hip-focused exercises (n = 39), traditional knee-focused exercise (n = 37), or free physical activity (n = 36). All patients received the same patient education. The primary outcome measure was the Anterior Knee Pain Scale (AKPS, 0-100). Secondary outcomes were usual and worst pain, Tampa Scale of Kinesiophobia, Knee Self-Efficacy Score, Euro-Qol (EQ-5D-5L), step-down test, and isometric strength. Blinded observers assessed outcomes at baseline, 3, and 12 months. The study was designed to detect a difference in AKPS >10 at 12 months. RESULTS: After 1 year, there were no significant between-group differences in any primary or secondary outcomes. Between-group differences for AKPS were as follows: knee versus free physical activity -4.3 (95% CI -12.3 to 3.7); hip versus free physical activity -1.1 (95% CI -8.9 to 6.7); and hip versus Knee 3.2 (95% CI -4.6 to 11.0). The cohort as a whole improved significantly at 3 and 12 months compared to baseline for all measures except for knee extension strength. CONCLUSION: After 1 year, there was no difference in effectiveness of knee exercise, hip exercise, or free physical activity, when combined with patient education in PFP.

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.

PURPOSE: To investigate changes in dural sac area after three different posterior decompression techniques in patients undergoing surgery for lumbar spinal stenosis. 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. CLINICAL TRIAL REGISTRATION: The study is registered at ClinicalTrials.gov reference on November 22th 2013 under the identifier NCT02007083.

A randomised controlled trial comparing the effectiveness of surgical and nonsurgical treatment for cervical radiculopathy.

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.

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).

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. TRIAL REGISTRATION: ClinicalTrials.gov NCT02323412 , First registered 23 December 2014.

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.

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. TRIAL REGISTRATION: ClinicalTrials.gov NCT02323412, First registered 23 December 2014.

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.

BACKGROUND: 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. The study is registered at ClinicalTrials.gov under the identifier NCT03704363 . The EudraCT Number: 2017-004861-29.

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.

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.