2024-517280-23-00已完成2 期
Evaluation of pain after intra-articular botulinum toxin injections in carpometacarpal osteoarthritis of the thumb
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evolution of the initial pain by Visual Analogue Scale compared to that measured at 3 months after the injection. Score from 0 to 10. 0 corresponds to the absence of pain and 10 to the maximum imaginable pain.
研究概览
简要总结
To show that botulinum toxin injection is superior to placebo injection in improving pain in symptomatic trapezometacarpal osteoarthritis at 3 months
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patient >18 years old
- •Patient with rhizarthrosis objectified by interrogation, radiography with at least 2 of the following criteria: osteophyte, joint space narrowing, subchondral sclerosis or geode
- •Patient who has had an X-ray of the wrist (face, profile and Kapandji incidence) to estimate the severity of the rhizarthrosis.
- •Visual analog scale (VAS) of pain > 4
- •Failure of well-conducted drug treatments with level 1 and 2 analgesics, anti-inflammatory drugs and orthotic devices
排除标准
- •History of surgery of the thumb column
- •Patient who has received an intra-articular trapezoidal metacarpal injection of corticoids, botulinum toxin or hyaluronic acid or other product within the last 6 months
- •Patient who has received a Botulinum toxin injection at any site within the last 3 months
- •Myasthenia or Lambert-Eaton disease, neuromuscular dysfunction, hypersensitivity to incobotulinumtoxin A, severe respiratory disorder or severe swallowing disorder
- •Patients with hypersensitivity to botulinum toxin or to any of the excipients (human albumin sucrose)
结局指标
主要结局
Evolution of the initial pain by Visual Analogue Scale compared to that measured at 3 months after the injection. Score from 0 to 10. 0 corresponds to the absence of pain and 10 to the maximum imaginable pain.
Evolution of the initial pain by Visual Analogue Scale compared to that measured at 3 months after the injection. Score from 0 to 10. 0 corresponds to the absence of pain and 10 to the maximum imaginable pain.
次要结局
未报告次要终点
研究者
Dr Pierre BLANC Investigateur Principal
Scientific
Centre Hospitalier Universitaire De Nice
研究点 (1)
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