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.

OBJECTIVE: To compare treatment effects between ultrasound guided lavage with corticosteroid injection and sham lavage with and without corticosteroid injection in patients with calcific tendinopathy of the shoulder. DESIGN: Pragmatic, three arm, parallel group, double blinded, sham controlled, randomised, superiority trial with repeated measurements over 24 months. SETTING: Six hospitals in Norway and Sweden. PARTICIPANTS: 220 adults with calcific tendinopathy of the shoulder, persistent for at least three months. INTERVENTIONS: Ultrasound guided deposit lavage plus subacromial injection of 20 mg triamcinolone acetonide and 9 mL 1% lidocaine hydrochloride (lavage+steroid); sham lavage plus subacromial injection of 20 mg triamcinolone acetonide and 9 mL 1% lidocaine hydrochloride (sham lavage+steroid); or sham lavage plus subacromial injection of 10 mL 1% lidocaine hydrochloride (sham). All patients received a physiotherapeutic treatment regimen consisting of four home exercises. MAIN OUTCOME MEASURES: The primary outcome was the result on the 48 point scale (0=worst; 48=best) of the Oxford Shoulder Score (OSS) at four month follow-up. Secondary outcomes included measurements on the short form of the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH) and of pain intensity up to 24 months. The influence of the size of the deposit at baseline and of the persistence or disappearance of the deposit was investigated. RESULTS: Data from 218 (99%) participants were included in the primary analysis. Differences between groups on the OSS at four months were not significant: lavage+steroid versus sham 0.2 (95% confidence interval -2.3 to 2.8; P=1.0); sham lavage+steroid versus sham 2.0 (-0.5 to 4.6; P=0.35); lavage+steroid versus sham lavage+steroid -1.8 (-4.3 to 0.7; P=0.47). After four months, 143 patients with insufficient treatment effect received supplementary treatment. At 24 months, none of the study procedures was superior to sham. No serious adverse events were reported. CONCLUSIONS: This study found no benefit for ultrasound guided lavage with a corticosteroid injection or for sham lavage with a corticosteroid injection compared with sham treatment in patients with calcific rotator cuff tendinopathy of the shoulder. TRIAL REGISTRATION: NCT02419040EudraCT 2015-002343-34; Ethical committee Norway 2015-002343-34; Ethical committee Sweden 2015/79-31; Clinicaltrials.gov NCT02419040.

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 reliability, validity, interpretability, and responsiveness of the Norwegian version of the Anterior Knee Pain Scale in patellofemoral pain.

PURPOSE: To determine the reliability, validity, responsiveness, and interpretability of the Norwegian Anterior Knee Pain Scale (AKPS) in patients with patellofemoral pain (PFP). METHODS: The AKPS was translated into Norwegian. One hundred and twelve patients with PFP participated in a randomized controlled trial. Fifty stable patients completed the AKPS at a one-week interval for test-retest reliability. Smallest detectable change (SDC) and floor/ceiling effects were evaluated. Validity and responsiveness were assessed using hypothesis testing for correlations with other scores and known-group validity. Minimal important change (MIC) and responsiveness were evaluated at three months. RESULTS: Intraclass correlation coefficient (ICCagreement) for sum score was 0.83. Smallest detectable change was 13. No floor/ceiling effects were found for total score, but ceiling effects were found on eight of 13 individual items. Hypothesis testing for construct validity and responsiveness was largely confirmed but correlations were moderate to low. The MIC was 11. Area under receiver operating characteristic curve was 0.66 (95% CI 0.56-0.77) indicating moderate responsiveness. CONCLUSIONS: The Norwegian AKPS had comparable measurement properties to other versions, with acceptable reliability and construct validity. We found moderate responsiveness which may be related to ceiling effects on several items.Implications for rehabilitationThe Anterior Knee Pain Scale (AKPS) is a commonly used outcome measure in patellofemoral pain, having acceptable reliability and moderate responsiveness.A change in AKPS total score of 11 points would be considered important by the patient, although changes up to 13 points may be due to measurement error.The AKPS has limitations including ceiling effects on most individual items in this patient population, and low correlation between pain and AKPS that questions the validity of the score. A revision of the score should be considered.

KALK study: ultrasound guided needling and lavage (barbotage) with steroid injection versus sham barbotage with and without steroid injection - protocol for a randomized, double-blinded, controlled, multicenter study.

BACKGROUND: For the treatment of calcific tendinitis of the shoulder a variety of treatment regimes exist. Commonly used treatment measures include medication with oral analgesics, corticosteroid injections, extracorporeal shockwave therapy, ultrasound guided needling and lavage, and surgical treatment. Earlier cohort studies suggest that patients may benefit from these treatments, but there are few randomized studies and conflicting evidence about the effectiveness of the various treatments. In the present study we aim to compare the effectiveness of ultrasound guided needling and lavage (barbotage) together with a steroid injection to sham barbotage with and without an additional steroid injection. METHODS: The study will be performed in six secondary-care institutions in Norway and Sweden. It is designed as a pragmatic, randomized, three-arm, parallel group, double-blinded, sham-controlled clinical trial with a 2-year follow-up. It will be performed on 210 patients, aged 30 years or older, presenting with painful arc, positive impingement sign and a calcium deposit > 5 mm. Randomization to one of the three treatment options will be performed by using an online central randomization system. The three treatment groups are barbotage together with a subacromial steroid injection (the barbotage group), sham barbotage together with a subacromial steroid injection (the steroid group) or sham barbotage without a subacromial steroid injection (the placebo group). In the placebo group the steroid injection will be replaced by a short-acting local anaesthetic. Standardized home-based post-treatment physiotherapy will be performed by all patients for 8 weeks. Follow-ups are at 2 and 6 weeks, 4, 8, 12 and 24 months after treatment was given and will be performed with the patients and the outcome assessors blinded for group assignment. Primary outcome will be the Oxford shoulder score at 4 month follow-up. Secondary outcome measures are the QuickDASH upper extremity score, the EQ-5D-5L general health score and visual analogue scales for pain at rest, during activity, and at night. DISCUSSION: The scientific evidence from this placebo-controlled trial will be of importance for future treatment recommendations in patients with calcific tendinitis. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02419040 , registered 10 April 2015 EudraCT: 2015-002343-34, registered 23 September 2015 (retrospectively registered).

Adhesive capsulitis: one sonographic-guided injection of 20 mg triamcinolon into the rotator interval.

The aim of this study was to establish a method for injecting corticosteroid into the rotator interval under sonographic guidance and to measure the effect on function, pain and range of motion after 4 and 12 weeks. This study involved a multicenter cohort trial and carried out at outpatient clinics of the physical medicine and rehabilitation departments in Oslo and Porsgrunn, Norway. 39 patients with adhesive capsulitis lasting between 3 and 12 months. Sonographic-guided corticosteroid and lidocaine injection into the rotator interval medial to the biceps tendon using 20 mg triamcinolon hexacetat and 3 ml 20 mg/ml xylocain. Change in the shoulder pain and disability index score (SPADI) after 12 weeks. The change in SPADI was 42 points (95 % confidence interval, 33-51). Changes in the secondary outcomes shoved highly statistically significant increase in active and passive range of motion. One ultrasound-guided corticosteroid injection into the rotator interval seems to give significant improvement in SPADI and active range of motion after 12 weeks. The protocol was evaluated by the research faculty at Oslo university hospital, dept of physical medicine. The study was regarded as regular clinical procedure as injections with triamcinolon already is standard treatment. No trial registration was obtained but the protocol presented the local ethics committee without comments.

Supervised exercises compared with radial extracorporeal shock-wave therapy for subacromial shoulder pain: 1-year results of a single-blind randomized controlled trial.

BACKGROUND: Evidence from a recent randomized controlled trial indicated that supervised exercises (SE) were more effective than radial extracorporeal shock-wave therapy (rESWT) for the treatment of subacromial shoulder pain in the short to medium term. Little knowledge exists about the long-term results of rESWT for subacromial pain. OBJECTIVE: The aim of this study was to evaluate the results of rESWT and SE provided to patients with subacromial shoulder pain after 1 year. DESIGN: This was a single-blind randomized controlled trial. SETTING: The study was conducted in the outpatient clinic of the Physical Medicine and Rehabilitation Department at Oslo University Hospital, Ullevaal, Norway. PATIENTS: One hundred four patients with subacromial shoulder pain lasting at least 3 months participated. Patients were randomly assigned to either an rESWT group (n=52) or an SE group (n=52). INTERVENTION: The rESWT intervention consisted of one session weekly for 4 to 6 weeks. The SE intervention consisted of two 45-minute sessions per week for up to 12 weeks. MEASUREMENTS: The primary outcome measure was the Shoulder Pain and Disability Index. Secondary outcome measures were questions regarding pain and function and work status. RESULTS: After 1 year, an intention-to-treat analysis showed no significant differences between the 2 groups for the primary outcome measure (-7.6 points, 95% confidence interval=-16.6 to 0.5) and pain, function, and medication use. Twenty-nine participants (60%) in the SE group versus 24 participants (52%) in the rESWT group were categorized as clinically improved. Thirty-eight participants in the SE group were at work compared with 30 participants in the rESWT group (odds ratio=1.1, 95% confidence interval=1.0 to 1.2). Fewer patients in the SE group had received additional treatments between 18 weeks and 1 year. LIMITATIONS: The lack of a placebo control group, the lack of a cost-benefit analysis, and the small sample size were limitations of the study. CONCLUSION: No significant difference was found between the SE and rESWT groups at the 1-year follow-up. More participants in the SE group had returned to work.

[Non-traumatic shoulder pain]. / Atraumatiske skulderlidelser.

BACKGROUND: Shoulder pain (usually non-traumatic) is the third most common cause of consultations for musculoskeletal pain in primary health care. This article discusses challenges within diagnostics and treatment of non-traumatic shoulder pain. MATERIAL AND METHODS: The article is based on literature identified through a non-systematic search in PubMed and the Cochrane library. RESULTS: One clinical test alone is generally not sufficient to make a pathoanatomical diagnosis. The incidence of degenerative changes in the normal population makes it difficult to interpret diagnostic images. MR is mainly indicated as part of a preoperative assessment and upon a specific indication. For diagnosis of the rotator cuff, ultrasound is as good as MR. Clinical studies do not show clear effects of specific treatment. This may be caused by methodological weaknesses of the trials evaluated and that patient characteristics and placebo effects contribute to the diagnosis. Injection with glucocorticoids seems to be well founded in patients with adhesive capsulate (frozen shoulder). With subacromial pain, supervised physical exercise and surgical treatment have similar effects, but there is not sufficient evidence to recommend particular treatments for rupture. INTERPRETATION: Non-traumatic shoulder pain is usually diagnosed adequately from the medical history and a combination of clinical tests; conservative treatment is most often adequate. When diagnostic imaging is required, ultrasound should be the first choice.

Predictors of shoulder pain and disability index (SPADI) and work status after 1 year in patients with subacromial shoulder pain.

BACKGROUND: Shoulder pain is a common complaint in primary health care and has an unfavourable outcome in many patients. The objectives were to identify predictors for pain and disability (SPADI) and work status in patients with subacromial shoulder pain. METHODS: Secondary analyses of data from a randomized clinical controlled trial were performed. Outcome measures were the absolute values of the combined Shoulder Pain and Disability Index (SPADI) and work status 1 year after treatment with supervised exercises (SE) or radial extracorporeal shockwave therapy (rESWT). Predictors of outcome were investigated using multiple linear regression (SPADI) and logistic regression (work status). RESULTS: 104 patients were included. Low education (≤ 12 years), previous shoulder pain, and a high baseline SPADI score predicted poor results with these variables explaining 29.9% of the variance in SPADI score at 1 year. Low education and poor self-reported health status predicted a work status of "not working": Odds Ratio, OR = 4.3(95% CI (1.3 to 14.9)), p = 0.02 for education, and OR = 1.06 (95% CI (1.0 to 1.1)), p = 0.001 for self-reported health status, respectively. Adjustments for age, gender, and treatment group were performed, but did not change the results. CONCLUSION: Education was the most consistent predictor of pain and disability, and work status at 1 year follow-up. Also, baseline SPADI score, previous shoulder pain and self-reported health status predicted outcome. TRIAL REGISTRATION: Clinical trials NCT00653081.

Determinants of the shoulder pain and disability index in patients with subacromial shoulder pain.

OBJECTIVE: To examine the influence of determinants on the Shoulder Pain and Disability Index. DESIGN: A cross-sectional study. Baseline registrations were applied. PATIENTS: Two hundred patients with subacromial shoulder pain lasting at least 3 months. METHODS: A questionnaire consisting of possible determinants, 2 independent variables regarding pain and 2 regarding function, and the outcome measurement. Two multiple regression models (one with and one without the independent variables of pain and function) for the Shoulder Pain and Disability Index, the 2 subscales, and the determinants, were performed. RESULTS: The included determinants explained 29% of the variance of the Shoulder Pain and Disability Index (25% for pain and 33% for disability subscale) with pain medication, emotional distress, flexion, and the hand-behind-back range accounting for 26%. When pain and function were included, the final model explained 65% of the variance, with gender, education and range of flexion showing significance. CONCLUSION: The determinants explained 26% of the variance of the Shoulder Pain and Disability Index, but explained only a minor proportion when pain and function were included. This supports the Shoulder Pain and Disability Index as a shoulder pain and disability questionnaire.

Radial extracorporeal shockwave treatment compared with supervised exercises in patients with subacromial pain syndrome: single blind randomised study.

OBJECTIVE: To compare the effectiveness of radial extracorporeal shockwave treatment with that of supervised exercises in patients with shoulder pain. DESIGN: Single blind randomised study. SETTING: Outpatient clinic of physical medicine and rehabilitation department in Oslo, Norway. PARTICIPANTS: 104 patients with subacromial shoulder pain lasting at least three months. INTERVENTIONS: Radial extracorporeal shockwave treatment: one session weekly for four to six weeks. Supervised exercises: two 45 minute sessions weekly for up to 12 weeks. Primary outcome measure Shoulder pain and disability index. RESULTS: A treatment effect in favour of supervised exercises at 6, 12, and 18 weeks was found. The adjusted treatment effect was -8.4 (95% confidence interval -16.5 to -0.6) points. A significantly higher proportion of patients in the group treated with supervised exercises improved-odds ratio 3.2 (1.3 to 7.8). More patients in the shockwave treatment group had additional treatment between 12 and 18 weeks-odds ratio 5.5 (1.3 to 26.4). CONCLUSION: Supervised exercises were more effective than radial extracorporeal shockwave treatment for short term improvement in patients with subacromial shoulder pain. TRIAL REGISTRATION: Clinical trials NCT00653081.

Responsiveness of the shoulder pain and disability index in patients with adhesive capsulitis.

BACKGROUND: Instruments designed to measure the subjective impact of painful shoulder conditions have become essential in shoulder research. The Shoulder Pain and Disability Index (SPADI) is one of the most extensively used scales of this type. The objective of this study was to investigate reproducibility and responsiveness of the SPADI in patients with adhesive capsulitis. METHODS: SPADI test-retest reproducibility was estimated by the "intraclass correlation coefficient" (ICC) and the "smallest detectable difference" (SDD). Responsiveness was assessed by exploring baseline and follow-up data recorded in a recently reported clinical trial regarding hydrodilatation and corticosteroid injections in 76 patients with adhesive capsulitis. "Standardized response mean" (SRM) and "reliable change proportion" (RCP) for SPADI were compared with corresponding figures for shoulder range-of-motion (ROM). The relationship between SPADI and ROM change scores was investigated through correlation and linear regression analyses. RESULTS: Results for test-retest reproducibility indicated a smallest detectable difference of 17 points on the 0-100 scale, and an intraclass correlation coefficient of 0.89. The SPADI was generally more responsive than ROM. Weak to moderately strong associations were identified between SPADI and ROM change scores. According to the regression model, the three variables baseline SPADI, baseline active ROM and change in active ROM together explained 60% of the variance in SPADI improvement. CONCLUSION: This study supports the use of SPADI as an outcome measure in similar settings.

Factor structure of the Shoulder Pain and Disability Index in patients with adhesive capsulitis.

BACKGROUND: The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that aims to measure pain and disability associated with shoulder disease. It consists of a pain section and a disability section with 13 items being responded to on visual analogue scales. Few researchers have investigated SPADI validity in specified diagnostic groups, although the selection of an evaluative instrument should be based on evidence of validity in the target patient group. The aim of the present study was to investigate factor structure of the SPADI in a study population of patients with adhesive capsulitis. METHODS: The questionnaire was administered to 191 patients with adhesive capsulitis. Descriptive statistics for items and a comparison of scores for the two subscales were produced. Internal consistency was analyzed by use of the Cronbach alpha and a principal components analysis with varimax rotation was conducted. Study design was cross-sectional. RESULTS: Two factors were extracted, but the factor structure failed to support the original division of items into separate pain and disability sections. CONCLUSION: We found minimal evidence to justify the use of separate subscales for pain and disability. It is our impression that the SPADI should be viewed as essentially unidimensional in patients with adhesive capsulitis.

Range of shoulder motion in patients with adhesive capsulitis; intra-tester reproducibility is acceptable for group comparisons.

BACKGROUND: Measurements of range of motion play a key role in shoulder research. The purpose of this study is to investigate intra-observer reproducibility of measurements of active and passive range of motion in patients with adhesive capsulitis. METHODS: The study was carried out in a population consisting of 32 patients with clinical signs of adhesive capsulitis. A specified measurement protocol was used, and range of motion in affected and non-affected shoulders was measured twice for each patient with a one-week interval. RESULTS: For most of the investigated individual movements, test-retest differences in range of motion score of more than approximately 15 degrees are not likely to occur as a result of measurement error only. Point-estimates for the intraclass correlation coefficient ranged from 0.61 to 0.93. CONCLUSION: Range of motion of patients with adhesive capsulitis can be measured with acceptable reproducibility in settings where groups are compared. Scores for individual patients should be interpreted with caution.