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.

Making shoulder pain simple in general practice: implementing an evidence-based guideline for shoulder pain, protocol for a hybrid design stepped-wedge cluster randomised study (EASIER study).

INTRODUCTION: Research suggests that current care for shoulder pain is not in line with the best available evidence. This project aims to assess the effectiveness, cost-effectiveness and the implementation of an evidence-based guideline for shoulder pain in general practice in Norway. METHODS AND ANALYSIS: A stepped-wedge, cluster-randomised trial with a hybrid design assessing clinical effectiveness, cost-effectiveness and the effect of the implementation strategy of a guideline-based intervention in general practice. We will recruit at least 36 general practitioners (GPs) and randomise the time of cross-over from treatment as usual to the implemented intervention. The intervention includes an educational outreach visit to the GPs, a computerised decision tool for GPs and a self-management application for patients. We will measure outcomes at patient and GP levels using self-report questionnaires, focus group interviews and register based data. The primary outcome measure is the patient-reported Shoulder Pain and Disability Index measured at 12 weeks. Secondary outcomes include the EuroQol Quality of Life Measure (EQ5D-5L), direct and indirect costs, patient's global perceived effect of treatment outcome, Pain Self-Efficacy and Brief Illness Perception Questionnaire. We will evaluate the implementation process with focus on adherence to guideline treatment. We will do a cost-minimisation analysis based on direct and selected indirect costs and a cost-utility analysis based on EQ5D-5L. We will use mixed effect models to analyse primary and secondary outcomes. ETHICS AND DISSEMINATION: Ethics approval was granted by the Regional Committee for Medical and Health Research Ethics-South East Norway (ref. no: 2019/104). Trial results will be submitted for publication in a peer-reviewed medical journal in accordance with Consolidated Standards of Reporting Trials. TRIAL REGISTRATION NUMBER: NCT04806191.

The clinical course of neck pain: Are trajectory patterns stable over a 1-year period?

BACKGROUND: Recent studies with data-driven approaches have established common pain trajectories. It is uncertain whether these trajectory patterns are consistent over time, and if a shorter measurement period will provide accurate trajectories. METHODS: We included 1,124 patients with non-specific neck pain in chiropractic practice. We classified patients into pre-defined trajectory patterns in each of four quarters of the follow-up year (persistent, episodic, and recovery) based on measures of pain intensity and frequency from weekly SMS. We explored the shifts between patterns and compared patients with stable and shifting patterns on baseline characteristics and clinical findings. RESULTS: 785 (70%) patients were in the same pattern in 1st and 4th quarters. Patients with episodic pattern in the 1st quarter shifted to other patterns more frequently than patients in the other patterns. A stable persistent pattern was associated with reduced function and higher scores on psychosocial factors. There was a decreased frequency of patients classified as persistent pattern (75% to 63%) and an increase of patients in recovery pattern (4% to 15%) throughout the four quarters. The frequency of patients classified as episodic remained relatively stable (21% to 24%). CONCLUSIONS: We found an overall stability of the persistent pattern, and that episodic patterns have more potential for shifts. Shifts mostly occurred between patterns closest in pain variation. The deviation in pattern distribution compared with previous studies suggests that the duration of measurement periods has an impact on the results of the classification. SIGNIFICANCE: Having persistent pain and having very minor pain is relatively stable over one year, while episodic pain has more potential for shifts. The duration of measurement periods appears to have an impact on the results of the classification. The given criteria resulted in a reduced frequency of episodic pattern due to shorter measurement periods. Our findings contribute to improved understanding and predicting NP using a combination of patient characteristics and trajectory patterns.

Shoulder MRI features with clinical correlations in subacromial pain syndrome: a cross-sectional and prognostic study.

BACKGROUND: Previous studies on shoulder patients have suggested that the prevalence of rotator cuff or bursa abnormalities are weakly related to symptoms and that similar findings are often found in asymptomatic persons. In addition, it is largely unknown whether structural changes identified by magnetic resonance imaging (MRI) affect outcome after treatment for shoulder pain. The purpose of this study was therefore to evaluate the presence of structural changes on MRI in patients with subacromial pain syndrome and to determine to what extent these changes are associated with symptoms and predict outcome after treatment (evaluated by the Shoulder Pain and Disability Index (SPADI)). METHODS: A prospective, observational assessment of a subset of shoulder patients who were included in a randomized study was performed. All participants had an MRI of the shoulder. An MRI total score for findings at the AC joint, subacromial bursa and rotator cuff was calculated. Multiple linear regression analysis was applied to examine the relationship between the MRI total score and the outcome measure at baseline and to examine to what extent the MRI total score was associated with the change in the SPADI score from baseline to the one year follow-up. RESULTS: There was a weak, inverse association between the SPADI score at baseline and the MRI total score (ß = -3.1, with 95% CI -5.9 to -0.34; p = 0.03), i.e. the SPADI score was higher for patients with a lower MRI total score. There was an association between the change in the SPADI score from baseline to the one year follow-up and the MRI total score (ß = 8.1, 95% CI -12.3 to -3.8; p < 0.001), with a poorer outcome for patients with a higher MRI total score. Both tendinosis (p = 0.01) and bursitis (p = 0.04) were associated with a poorer outcome after one year. CONCLUSIONS: In this study, MRI findings were significantly associated with the change in the SPADI score from baseline and to one year follow-up, with a poorer outcome after treatment for the patients with higher MRI total score, tendinosis and bursitis on MRI. TRIAL REGISTRATION: Clinicaltrials.gov no NCT01441830 . September 28, 2011.

Effectiveness of Radial Extracorporeal Shock Wave Therapy (rESWT) When Combined With Supervised Exercises in Patients With Subacromial Shoulder Pain: A Double-Masked, Randomized, Sham-Controlled Trial.

BACKGROUND: Subacromial shoulder pain is a common complaint, and radial extracorporeal shock wave therapy (rESWT) is increasingly used to treat this condition. Although many therapists use rESWT in combination with supervised exercises, no studies have evaluated the additional effect of rESWT with supervised exercises for subacromial shoulder pain. PURPOSE: To assess whether rESWT is more effective than sham rESWT when combined with supervised exercises for improving pain and function in patients with subacromial shoulder pain. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: Patients between 25 and 70 years of age with subacromial shoulder pain with and without calcification in the rotator cuff lasting at least 3 months were assessed for eligibility; 143 patients were recruited. Participants were allocated (1:1) by computer-generated randomization in blocks of 20 to receive either rESWT or sham rESWT in addition to supervised exercises. The rESWT and sham rESWT were performed once a week with additional supervised exercises once a week for the first 4 weeks. The following 8 weeks, the patients received supervised exercises twice a week. The primary outcome was change in the Shoulder Pain and Disability Index (SPADI) after 24 weeks. Patients and outcome assessors were masked to group assignment. RESULTS: At 24 weeks, participants in both the sham group and the rESWT group had improved ( P < .001) in SPADI score compared with baseline (-23.9 points [SD, 23.8 points] and -23.3 points [SD, 25.0 points], respectively), but there were no differences between the groups (mean difference 0.7; 95% CI, -6.9 to 8.3; P = .76). Prespecified subgroup analysis of patients with calcification in rotator cuff showed that the rESWT group had a greater improvement in SPADI score after 24 weeks (mean difference -12.8; 95% CI, -24.8 to -0.8; P = .018). CONCLUSION: Radial ESWT offered no additional benefit to supervised exercises in the treatment of subacromial shoulder pain after 24 weeks, except in the subgroup of patients with calcification in the rotator cuff. Registration: NCT01441830 ( ClinicalTrials.gov identifier).

Is radial Extracorporeal Shock Wave Therapy (rEWST) combined with supervised exercises (SE) more effective than sham rESWT and SE in patients with subacromial shoulder pain? Study protocol for a double-blind randomised, sham-controlled trial.

BACKGROUND: Subacromial shoulder pain is a common complaint. Radial Extracorporeal Shock Wave Therapy (rESWT) has being increasingly used to treat calcific and non-calcific tendinosis, although there is no evidence of the effectiveness of rESWT in non-calcific tendinosis of the rotator cuff. A randomised single blind study showed that the short-term effect of supervised exercises (SE) was significantly better than rESWT on subacromial shoulder pain, but both groups improved. In a clinical trial on achilles tendinopathy rESWT improved the effectiveness of treatment with eccentric loading. The objective of this present study is to evaluate if rESWT in addition to SE is more effective in improving shoulder pain and function compared with sham rESWT and SE in patients with subacromial shoulder pain. METHODS/DESIGN: This is a double blind, randomised sham-controlled trial which is performed at the shoulder clinic at the Department of Physical Medicine and Rehabilitation in Oslo University Hospital, Norway. One-hundred-forty-four patients with subacromial shoulder pain lasting at least 3 months, age from 25 to 70 years old are included in the trial. Patients are randomly allocated in 1:1 ratio to receive either rESWT or sham rESWT once a week in addition to SE once a week for the initial 4 weeks. Subsequently SE are provided twice a week for 8 weeks. The primary outcome measure is a change in the Shoulder Pain and Disability Index (SPADI) at 24 weeks follow-up. Secondary outcomes include return to work, pain at rest and on activity, function, and health related quality of life. The patients, the physiotherapist providing the exercise regimen and the outcome assessor are blinded to group assignment. The physiotherapist providing the rESWT is not blinded. DISCUSSION: Because of the extensive use of rESWT in the treatment of subacromial shoulder pain the results of this trial will be of importance and have impact on clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT01441830.