Short-term efficacy of a single ultrasound-guided intra-articular injection of botulinum toxin A associated with splinting for base-of-thumb osteoarthritis on pain at 3 months: A randomized placebo-controlled pilot study - RHIBOT

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)0 个研究点目标入组 60 人开始时间: 2017年6月15日最近更新: 2021年6月7日

试验速览

暂无简介。

•Patient aged >/= 18 years
•Symptoms involving the base-of-thumb
•Mean base-of-thumb pain intensity in the previous 48 hours on NRS >/= 30
•Radiographic evidence of at least 2 of 4 radiographic items: osteophytes, joint space narrowing, subchondral bone sclerosis, or subchondral cysts
•Physical examination findings consistent with BTOA
•Written consent
•Health cover
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 18
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 42

•- History of thumb surgery
•- History of inflammatory or crystal-associated rheumatic disease involving the hands
•- Neurological disorders involving the hands
•- Collagen disorders involving the hands : Dupuytren, Marfan or Ehlers-Danlos diseases
•- Ostearthritis affecting the scaphotrapezial joint
•- Hand or wrist trauma - Hand or wrist intra-articular injections - Contra-indications to BTA injections or splinting
•- Cognitive or behavioral disorders making the assessment impossible
•- Inability to speak or write French
•- Bilateral rhizarthrosis without dominant affected site
•- Pregnancy and breast feeding

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