Medium-and Long-term Efficacy of Two Ultrasound-guided Intra-articular Injections of onabotulinumtoxinA (Botox®) Combined With Custom-made Rigid Splinting in Painful Base-of-thumb Osteoarthritis : a Randomized Double-blind Controlled Trial in Three-parallel Arms
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Base-of-thumb pain on a self-administered 11-point numeric rating scale
研究概览
简要总结
The main objective of this study will be to compare the effects of 2 intra-articular injections of onabotulinumtoxinA with those of 1 intra-articular injection of onabotulinumtoxinA and 1 of normal saline and those of 2 intra-articular injections of normal saline on base-of-thumb pain at 6 months after the first injection.
详细描述
The base of the thumb is a frequent location of osteoarthritis. Base-of-thumb osteoarthritis affects middle-aged and older individuals and results in base-of-thumb pain and limitations in hand-specific activities. For the medium and long term, evidence suggests that splinting could reduce pain and improve hand function. For the short term, a combination of conservative treatments is recommended, with small-to-moderate treatment effect. However, use of intra-articular treatments (e.g., glucocorticoids and hyaluronan) for the short and medium term is currently debated. Use of intra-articular botulinum toxin A injection as a pain modulator in joint diseases has recently raised interest. Botulinum toxin A is a neurotoxin produced by Clostridium botulinum that inhibits acetylcholine release into the synaptic cleft in cholinergic nerve terminals. Additionally, treatment with botulinum toxin A showed intrinsic antinociceptive effects in various animal models of joint diseases.
In a pilot single-centred randomized controlled trial of 60 participants with painful base-of-thumb osteoarthritis, the investigators compared the effects of a single intra-articular injection of onabotulinumtoxinA (Botox® ) with those of a single intra-articular injection of normal saline on base-of-thumb pain, and found a significant reduction in pain.
Several perspectives raised from this pilot study. Like in the treatment of spasticity, repeated courses of intra-articular injections onabotulinumtoxinA may be necessary to obtain sustained analgesic effects over time. A replication of these findings in a multicentred setting, analysis of cost-effectiveness and description of safety at longer term are also needed before the official recommendation of this treatment. In RHIBOT II, the investigators hypothesize that 2 ultrasound-guided intra-articular injections of onabotulinumtoxinA, as an add-on therapy to custom-made rigid splinting, could reduce base-of-thumb pain at 6 months after the first injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Individuals aged at least 18 years;
- •Pain intensity of at least 30 on a self-administered 11-point pain numeric rating scale (0: no pain to 100: maximal pain);
- •Pain involving the base of the thumb;
- •X-ray evidence of trapezometacarpial osteoarthritis with at least two of the following items involving the trapezometacarpial joint: osteophytes, joint space narrowing, subchondral bone sclerosis, or subchondral cysts;
- •1990 ACR classification criteria for hand osteoarthritis adapted to trapezometacarpial osteoarthritis.
- •Patient able to give written informed consent prior to participation in the study
- •Affiliation with a mode of social security (profit or being entitled).
- •Negative pregnancy test in women of childbearing potential
排除标准
- •• Secondary osteoarthritis;
- •History of thumb surgery, inflammatory or crystal-associated rheumatic disease, or epilepsy;
- •Uncontrolled dysphagia, pneumonia, cardiovascular diseases, or clinical or subclinical signs of neuromuscular transmission disorders;
- •Contra-indication to onabotulinumtoxinA;
- •Neurological disorders involving the hands other than carpal tunnel syndrome;
- •Collagen disorders involving the hands;
- •Osteoarthritis predominating at the scaphotrapezial joint on x-ray;
- •Bilateral trapezometacarpial osteoarthritis without a predominant painful side;
- •Hand or wrist trauma for up to 2 months;
- •Intra-articular treatments for up to 2 months;
- •Use of IM, IV or oral corticosteroids for up to 2 months.
- •Protected adults (including individual under guardianship by court order)
- •Pregnant women and lactation; lack of contraception for women of childbearing potential
- •Patient participating in another investigational therapeutic study
- •Patient unable to speak and read french
研究组 & 干预措施
1 intra-articular injection of onabotulinumtoxinA and 1 of normal saline
干预措施: Normal saline (placebo) (Drug)
2 intra-articular injections of onabotulinumtoxinA
干预措施: OnabotulinumtoxinA (Drug)
1 intra-articular injection of onabotulinumtoxinA and 1 of normal saline
干预措施: OnabotulinumtoxinA (Drug)
2 intra-articular injections of normal saline
干预措施: Normal saline (placebo) (Drug)
结局指标
主要结局
Base-of-thumb pain on a self-administered 11-point numeric rating scale
时间窗: 6 months
French version of the self-administered base-of-thumb pain numeric rating scale (0: no pain to 100: maximal pain)
次要结局
- Base-of-thumb pain on a self-administered 11-point numeric rating scale(1 and 12 months)
- Hand-specific activity limitations on the self-administered Cochin Hand Function Scale(6 and 12 months)
- patient global assessment on a self-administered 11-point numeric rating scale(6 and 12 months)
- health-related quality of life on the self-administered EQ-5D-5L questionnaire(6 and 12 months)
- Osteoarthritis Research Society International-Outcome Measures in Rheumatology response(6 and 12 months)
- estimated total costs and incremental cost-utility ratio(12 months)