Intramuscular versus ultrasound-guided intratenosynovial glucocorticoid injection for tenosynovitis in patients with rheumatoid arthritis: a randomised, double-blind, controlled study.

Abstract

OBJECTIVE:

The aim of this study was to compare the efficacy of intramuscular versus ultrasound (US)-guided intratenosynovial glucocorticoid injection in providing disease control after 2, 4 and 12 weeks in patients with rheumatoid arthritis(RA) with tenosynovitis.

METHODS:

Fifty patients with RA and tenosynovitis were randomised into two double-blind groups: (A) 'intramuscular group', receiving intramuscular injection of betamethasone and US-guided intratenosynovial isotonic saline injection and (B) 'intratenosynovial group' receiving saline intramuscularly and US-guided intratenosynovial betamethasone injection. All patients were in stable disease-modifying anti-rheumatic drug treatment prior to and during the study. Patients were excluded, and considered non-responders, if any treatments were altered during the follow-up period. 'US tenosynovitis remission', defined as US tenosynovitis grey-scale score ≤1 and colour Doppler score=0, was assessed at week 4 (primary outcome), and weeks 2 and 12, using non-responder imputation for missing data.

RESULTS:

US tenosynovitis remission at week 4 was achieved in 25% (6/24) in the 'intramuscular group' versus 64% (16/25) in the 'intratenosynovial group', that is, a difference of -39 percentage point (pp) (CI -65pp to -13pp), Fisher exact test p=0.001. Corresponding values for the 'intramuscular group' versus the 'intratenosynovial group' at 2 and 12 weeks were 21% (5/24) versus 48% (13/25), that is, a difference of -27pp (CI -53pp to -2pp), p=0.072 and 8% (2/24) versus 44% (11/25), that is, difference of -36pp (-58pp to -13pp), p=0.003. Most US, clinical and patient-reported scores improved more in the 'intratenosynovial group' at all follow-up visits.

CONCLUSIONS:

In this randomised double-blind clinical trial, patients with RA and tenosynovitis responded significantly better to US-guided intratenosynovial glucocorticoid injection than to intramuscular glucocorticoid injection, both at 4 and 12 weeks follow-up.

TRIAL REGISTRATION NUMBER:

EudraCT nr: 2013-003486-34.

• Authors: Mads Ammitzbøll-Danielsen, Mikkel Østergaard, Viktoria Fana, Daniel Glinatsi, Uffe Møller Døhn, Lykke Midtbøll Ørnbjerg, Esperanza Naredo, Lene Terslev
• Journal: Annals of the rheumatic diseases (Ann Rheum Dis) Vol. 76 Issue 4 Pg. 666-672 (04 2017) ISSN: 1468-2060 [Electronic] England
• PMID: 27604532 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)
• Copyright: Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Chemical References

• Glucocorticoids
• Betamethasone

Topics

• Aged
• Arthritis, Rheumatoid (complications)
• Betamethasone (administration & dosage)
• Double-Blind Method
• Female
• Glucocorticoids (administration & dosage)
• Humans
• Injections, Intra-Articular
• Injections, Intramuscular
• Male
• Middle Aged
• Tenosynovitis (diagnostic imaging, drug therapy, etiology)
• Ultrasonography, Doppler, Color
• Ultrasonography, Interventional