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.

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).

Smoking as a risk factor for chronic musculoskeletal complaints is influenced by age. The HUNT study.

Chronic musculoskeletal complaints (MSCs) are among the major health problems, and cross-sectional studies suggest an association between smoking and MSCs. The causal relationship, however, is not known. The present study is designed to assess the association between smoking and chronic MSCs, and is based on data from a large longitudinal cohort study of all inhabitants ⩾20years in Nord-Trøndelag County (Helse Undersøkelsen i Nord-Trøndelag -HUNT), conducted in 1995-97 (HUNT 2) and 2006-08 (HUNT 3). The study population consisted of 15,134 subjects without chronic MSCs and valid exposure data on smoking at baseline (HUNT 2). The outcome was defined as presence of chronic MSCs at follow-up (HUNT 3). The results show that smoking at baseline represents a 20% increased risk (IRR=1.20, 95% CI 1.14-1.27, P=0.0001) for chronic MSCs at follow-up. The risk for chronic MSCs by daily smoking decreased with increasing age up to 50years; after this, there was no significant association. The results show that modifiable risk factors like smoking should be included in public health intervention programs for MSCs.

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.

Clinical, socio-demographic and radiological predictors of short-term outcome in rotator cuff disease.

BACKGROUND: Shoulder pain is common with rotator cuff disease as the most frequently used clinical diagnosis. There is a wide range of treatment options for this condition, but limited evidence to guide patients and clinicians in the choice of treatment strategy. The purpose of this study was to investigate possible prognostic factors of short-term outcome after corticosteroid injection for rotator cuff disease. METHODS: We performed analyses of data from 104 patients who had participated in a randomized controlled study. Socio-demographic, clinical and radiographic baseline factors were assessed for association with outcome at six-weeks follow-up evaluated by Shoulder Pain and Disability Index (SPADI) and patient perceived outcome. Factors with significant univariate association were entered into multivariate linear and logistic regression analyses. RESULTS: In the multivariate analyses; a high SPADI score indicating pain and disability at follow-up was associated with decreasing age, male gender, high baseline pain and disability, being on sick-leave, and using regular pain medication. A successful patient perceived outcome was associated with not being on sick-leave, high active abduction, local corticosteroid injection and previous cortisone injections. Structural findings of rotator cuff tendon pathology on MRI and bursal exudation or thickening on ultrasonography did not contribute to the predictive model. CONCLUSIONS: Baseline characteristics were associated with outcome after corticosteroid injection in rotator cuff disease. Sick-leave was the best predictor of poor short-term outcome. TRIAL REGISTRATION: Clinical trials NCT00640575.

Subacromial ultrasound guided or systemic steroid injection for rotator cuff disease: randomised double blind study.

OBJECTIVE: To compare the effectiveness of ultrasound guided corticosteroid injection in the subacromial bursa with systemic corticosteroid injection in patients with rotator cuff disease. DESIGN: Double blind randomised clinical trial. SETTING: Outpatient clinic of a physical medicine and rehabilitation department in Oslo, Norway. Patients 106 patients with rotator cuff disease lasting at least three months. INTERVENTIONS: Ultrasound guided corticosteroid and lidocaine injection in the subacromial bursa and lidocaine injection in the gluteal region (local group); corticosteroid and lidocaine injection in the gluteal region and ultrasound guided lidocaine injection in the subacromial bursa (systemic group). MAIN OUTCOME MEASURES: Difference in improvement in the overall shoulder pain and disability index score after six weeks. RESULTS: Six weeks after the intervention, the mean difference in improvement in overall shoulder pain and disability index score between the local group and the systemic group was -5.2 (95% confidence interval -13.9 to 3.5); it was -4.1 (-12.3 to 4.1, P=0.32) after adjustment for baseline score. A small but statistically significant difference in improvement between groups occurred in favour of the local group for two secondary outcome measures: the Western Ontario rotator cuff index (8.1, 0.7 to 15.6) and change in main complaint (2.0, 0 to 4). CONCLUSIONS: No important differences in short term outcomes were found between local ultrasound guided corticosteroid injection and systemic corticosteroid injection in rotator cuff disease. TRIAL REGISTRATION: Clinical trials NCT00640575.