No abstract

IntroductionOsteoarthritis of the trapeziometacarpal joint affects approximately 10%–25% of women, especially those who are postmenopausal. It may result in thumb dysfunction. Among the treatments, intra-articular injections of corticosteroid (CS) and hyaluronic acid (HA) are both effective and recommended. However, clinical trials have shown that HA improves functional capacity, whereas CS only produces a decrease in pain. The synergy of these two drugs has not been evaluated. The primary goal of this study was to determine whether the association between HA and CS produce an additional decrease of more pain during thumb movement at three months postinjection, compared to the level of pain relief from CS alone.Methods and analysisRHIZ’ART is a prospective, multicentre, comparative, randomised, controlled, double-blind trial. Patients referred to the rheumatology department for thumb rhizarthrosis will receive an injection of betamethasone with HA or placebo (serum saline) based on central randomisation and stratification by centre. Injections will be given under ultrasound guidance. The primary outcome will compare the pain Visual Analogue Scale with motion at three months for both groups using a mixed model. The expected decrease in pain intensity in the CS group is 25% and 35% in the CS with HA group. In order to achieve a 80% power for detecting this difference with α set at 5%, 73 patients are needed in each group (146 total). The main secondary outcomes are the Cochin score (hand function) and grip strength. Follow-up visits are at 1, 3, 6 and 12 months.Ethics and disseminationThe study project has been approved by the appropriate ethics committee (CPP île de France III, 2017-002298-20). In agreement with current French regulations, a signed informed written consent will be obtained from each patient. Results of the main trial and of the secondary endpoints will be submitted for publication in a peer-reviewed journal.Trial registration number NCT03431584.

IntroductionDegenerative acromioclavicular joint pain accounts for about 4% of shoulder pain. Various medical and non-medical treatment strategies are available for acromioclavicular joint disease but it is difficult to conduct a comparative evaluation of these treatments. The few studies dealing with the medical management of the disease have conducted no comparative assessment of drug therapies, physiotherapy, joint manipulation and corticosteroid injections. The primary goal of this study is to determine whether manual therapy is not inferior to ultrasound-guided injection of a corticosteroid preparation to decrease acromiocalvicular joint pain at 3 months.Methods and analysisThe acromioclavicular arthropathy managed by manual therapy is a monocentric, comparative, randomised, controlled, non-inferiority study conducted in the Rheumatology Department of Vendée Departmental Hospital, involving two parallel groups receiving either corticosteroid injections or manual therapy. The inclusion criteria are patients who suffer from pain in the shoulder or the proximal part of the arm, with pain located on palpation of the acromioclavicular joint associated with a positive cross-arm test and a positive O’Brien test. Randomisation will be at a 1:1 ratio. The injection group will receive a single ultrasound-guided injection of 1 mL of Diprostène and the manual therapy group will receive between one and three sessions at intervals of one per week. The primary outcome will be to compare the Visual Analogue Scale for pain-activity-related score at 3 months for both groups.Ethics and disseminationThe study project has been approved by the appropriate ethics committee (Committee for the Protection of Patients Ouest II in Angers, 30 April 2019, with the registration number of 2019/22). In agreement with current French regulations, signed informed written consent will be obtained from each patient. Results of the main trial and of the secondary endpoints will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT03951480.