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

Abstract

BackgroundFor 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.MethodsThe 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.DiscussionThe scientific evidence from this placebo-controlled trial will be of importance for future treatment recommendations in patients with calcific tendinitis.Trial registrationClinicalTrials.gov: NCT02419040, registered 10 April 2015EudraCT: 2015-002343-34, registered 23 September 2015 (retrospectively registered)Electronic supplementary materialThe online version of this article (doi:10.1186/s12891-017-1501-9) contains supplementary material, which is available to authorized users.

Measures of Adult Shoulder Function

“…Up to the end of 2015, the OSS had been used in seven randomized controlled trials (2). The OSS continues to be used as an outcome in trials published in the last 5 years, including trials for the following: Surgical versus nonsurgical treatment for proximal humerus fractures (197) Intraoperative platelet‐rich plasma versus local anesthetic injection for arthroscopic repair (111) Ultrasound added to exercise and mobilization for frozen shoulder (198) Supervised exercise versus home exercise for frozen shoulder (199) Cement‐augmented locking plate versus proximal humerus nail for surgical neck proximal humerus fractures (114) Arthroscopic subacromial decompression versus placebo for subacromial shoulder pain (200) Arthroscopic suprapectoral versus open subpectoral biceps tenodesis (112) Ultrasound‐guided needling and lavage with or without glucocorticoid injection versus placebo for calcific tendinitis (201). Addition of platelet‐rich plasma applied to tendon repair site after double‐row arthroscopic supraspinatus repair (202) Extracorporeal shock wave therapy with or without kinesiotaping for calcific tendinitis (203) Arthroscopic implantation of a subacromial balloon spacer for treating massive rotator cuff tear (204) Stemmed versus stemless total shoulder arthroplasty for glenohumeral osteoarthritis (205) Reversed total shoulder arthroplasty versus nonoperative treatment for displaced proximal humerus fracture (206) …”

Effectiveness of non-surgical management in rotator cuff calcific tendinopathy (the effect trial): protocol for a randomised clinical trial

“…As the effectiveness of exercise has been shown to be similar to other forms of treatment (eg, surgery) in people with RCRSP, we hypothesise that ET will be as effective as ESWT and US-PICT in the short-term and long term in terms of pain and function in people with RCCT 13 18–24. Additionally, we hypothesise that the wait-and-see group will also report some improvements in the outcomes measured during the follow-up assessments due to the self-limited nature of RCCT 1 10 25 26…”

Effectiveness of Extracorporeal Shock Wave Therapy Reduces Leg Cramps in Patients of Lumbar Degenerative Disorders: A Retrospective Study

“…Shock wave therapy is an effective method to dissolve calcification and stimulate tissue regeneration by generating high-energy mechanical impulses through regular alternating compression and decompression processes [ 12 , 13 ]. In the 1970s, shock wave therapy was widely used to treat kidney and gallbladder stones.…”