OP0125 A Randomised, Double-Blind, Controlled Study of Intramuscular versus Ultrasound Guided Peritendinous Betamethasone Injection for Tenosynovitis in Rheumatoid Arthritis Patients
Authors: M. Ammitzbøll-Danielsen, M. Østergaard, V. Fane, D. Glinatsi, U.M. Døhn, L.M. Ørnbjerg, E. Naredo, L. Terslev
Journal: Annals of the Rheumatic Diseases (2016)

<h3>Background</h3> Intra-articular glucocorticoid (eg. betamethasone (BM)) injections are commonly used during flares in rheumatoid arthritis (RA)<sup>1</sup>. Currently, evidence on the best approach to treat tenosynovitis (TS) is lacking. <h3>Objectives</h3> To compare the effect of intramuscular (im) and ultrasound (US) guided peritendinous BM injection for TS in RA patients, after 4 and 12 weeks. <h3>Methods</h3> Fifty RA patients with TS were randomised into two double-blinded groups: Group A ("i.m. BM group") received im injection of 14 milligrams (2 ml) of BM and US-guided saline injection in up to two tendon sheaths (maximum 1 ml saline for each tendon sheath) and group B ("US guided peritendinous group") received 2 ml of saline im and US guided BM injection in up to two tendon sheaths (maximum 7 milligrams (1 ml) of BM for each tendon sheath). All patients were in stable anti-inflammatory treatment prior to and during the study. Patients were excluded, and considered non-responders, if treatment changes were made during the follow-up period. TS was assessed at baseline, 4 and 12 weeks using the semi-quantitative scoring system for Grey scale (GS) (0–3) and Colour Doppler (CD) (0–3) proposed by the OMERACT US group and a patient reported visual analogue scale (0–100 mm) for pain TS (VAS TS). If two tendon sheaths were treated, the mean score was used for statistical calculation. For US assessment a GE Logiq E9 US unit with a high frequency linear 6–15 ML probe and CD settings according to published recommendations were used. The predefined primary outcome was a US-TS GS score ≤1 and CD score =0, at week 4, with a non-responder imputation (NRI) used for missing data. The same outcome was used at week 12, with a NRI used for missing data. <h3>Results</h3> Forty-nine patients received treatment, 24 in group A and 25 in group B. The completion rate for group A/B was 23/25 at 4 weeks and 15/18 at 12 weeks. There was no significant baseline difference between the groups, except that two tendon sheaths were injected more often in group A (10) compared to B (3). The chance of achieving the primary outcome at week 4 was 0.25 (95% Confidence limits; 0.08; 0.42) in group A and 0.64 (0.45; 0.83) in group B and for 12 weeks 0.08 (0.00; 0.19) in group A and 0.40 (0.21; 0.59) in group B (Chi-Square; 4 weeks =0.008; 12 weeks =0.020). Likewise VAS TS showed significant better response in group B versus group A (Mann-Whitney U test; 4 weeks =0.027; 12 weeks =0.003). Baseline values and 4 and 12 weeks changes for GS, CD and VAS TS are presented in table 1. <h3>Conclusions</h3> In a randomized double-blind clinical trial, RA patients with tenosynovitis responded significantly better to US guided peritendineus glucocorticoid injection compared to i.m. glucocorticoid injection, both at 4 and 12 weeks, both when assessed by US and patient-reported outcomes. <h3>References</h3> Hetland ML, Ostergaard M, Ejbjerg B, et al. Short- and long-term efficacy of intra-articular injections with betamethasone as part of a treat-to-target strategy in early rheumatoid arthritis: impact of joint area, repeated injections, MRI findings, anti-CCP, IgM-RF and CRP. Annals of the Rheumatic Diseases 2012;71 <h3>Disclosure of Interest</h3> None declared