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


BACKGROUND
EudraCT nr: 2013-003486-34.
Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.|Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Mads
M
Ammitzbøll-Danielsen
Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.|Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Mikkel
M
Østergaard
Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.
Viktoria
V
Fana
Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.|Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Daniel
D
Glinatsi
Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.
Uffe Møller
UM
Døhn
Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.
Lykke Midtbøll
LM
Ørnbjerg
Department of Rheumatology, Hospital General Universitario Gregorio Marañón and Universidad Complutense, Madrid, Spain.
Esperanza
E
Naredo
Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.
Lene
L
Terslev
D000368:Aged; D001172:Arthritis, Rheumatoid / Q000150:complications*; D001623:Betamethasone / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D007270:Injections, Intra-Articular; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D013717:Tenosynovitis / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000209:etiology; D018615:Ultrasonography, Doppler, Color; D018084:Ultrasonography, Interventional
D005938:Glucocorticoids; D001623:Betamethasone
Corticosteroids; Inflammation; Rheumatoid Arthritis; Synovitis; Ultrasonography