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Intramuscular versus ultrasound-guided intratenosynovial glucocorticoid injection for tenosynovitis in patients with rheumatoid arthritis: a randomised, double-blind, controlled study
  1. Mads Ammitzbøll-Danielsen1,2,
  2. Mikkel Østergaard1,2,
  3. Viktoria Fana1,
  4. Daniel Glinatsi1,2,
  5. Uffe Møller Døhn1,
  6. Lykke Midtbøll Ørnbjerg1,
  7. Esperanza Naredo3,
  8. Lene Terslev1
  1. 1Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark
  2. 2Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
  3. 3Department of Rheumatology, Hospital General Universitario Gregorio Marañón and Universidad Complutense, Madrid, Spain
  1. Correspondence to Dr Mads Ammitzbøll-Danielsen, Rigshospitalet, Centre of Head and Orthopaedics, Center for Rheumatology and Spine Diseases, Copenhagen Center for Arthritis Research, Indgang 5, stuen, Ndr. Ringvej 57, Glostrup 2600, Denmark; ammitz7{at}gmail.com

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.

  • Synovitis
  • Rheumatoid Arthritis
  • Ultrasonography
  • Corticosteroids
  • Inflammation

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