Corticosteroids injections versus corticosteroids with hyaluronic acid injections in rhizarthrosis: the randomised multicentre RHIZ’ART trial study protocol

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.

New Trends in Injection-Based Therapy for Thumb-Base Osteoarthritis: Where Are We and where Are We Going?

“…Interestingly, the protocol of a new randomized multicenter study, the RHIZ’ART trial, aimed to analyze, for the first time, the possible synergistic effect of corticosteroids associated with HA, compared to steroid alone, in TBOA patients, was published last year ( Cormier et al, 2019 ). The Authors would like to compare VAS pain, Cochin score, grip strength and opposition force, 3 months after a single injection of 0.5 ml of corticosteroid and 0.5 ml of physiological saline or 0.5 ml of corticosteroid and 0.5 ml of HA and would like to continue the follow-up until 12 months.…”

Follow‐up evaluation of temporomandibular joints using magnetic resonance imaging after mandibular trauma: Case series analysis of young adult males

“…23,26,27 Dexamethasone has been used therapeutically in inflammation, especially on the small joint, with its potent anti-inflammatory effects from the inhibition of the production and secretion of inflammatory cytokines such as interferon-gamma, interleukins, tumor necrosis factoralpha, and factor stimulating granulocytic and macrophage colonies. 28,29 Arthrocentesis is another valuable method to improve TMJ symptoms and promote healing of the TMJ by the lavage of the development of a traumatic condition. 4 Other than these clinical studies, no clear evidence has been reported to support the necessity and efficacy of intervention for the TMJ.…”

Intra-articular corticosteroids for treatment of temporomandibular joint internal disorders: protocol for systematic review and network meta-analysis

“…11 Corticosteroids have been used therapeutically in the inflammation of different joints, showing positive results in small joints, such as the trapeziometacarpal. 12 Corticosteroids are one of the tools used in the management of TMJ internal disorders, generating the best anti-inflammatory effect due to the inhibition of the production and secretion of proinflammatory cytokines such as interleukins, tumour necrosis factor alpha, interferon gamma and factor stimulating granulocytic and macrophage colonies by direct interference on cascades and genomic mechanisms. They also inhibit the accumulation of macrophages and neutrophils in inflammatory foci because they repress the expression of endothelial adhesion molecules and the synthesis of the plasminogen activator.…”

“… 11 Corticosteroids have been used therapeutically in the inflammation of different joints, showing positive results in small joints, such as the trapeziometacarpal. 12 …”