Capsaicin in Digital Osteoarthritis Versus Control : a Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Intensity of pain in the fingers
研究概览
简要总结
The objective of this multicentric, randomized controlled double-blind clinical trial is to demonstrate the efficacy of transdermal application of capsaicin in patients with painful digital osteoarthritis with a neuropathic pain component.
Participants will receive either a transdermal patch of capsaicin 179 mg (8%) or the control treatment (capsaicin 0.04%).
Researchers will compare the intensity of pain in the fingers at day 60 in the capsaicin 8% group versus capsaicin 0.04% (control arm)
详细描述
Visit 0 : Screening visit (D0 - 30 days): Screen for eligibility
Visit 1 :Inclusion visit (D0): Randomization and blinded patch application of capsaicin 8% or 0.04%
Visit 2: Follow-up visit 1 (D60 + 7 days): Assessment +/- Patch renewal. Patients with finger pain still greater than 4/10 may receive an open application of a capsaicin 8%
Visit 3:Follow-up visit 2 (D120 +/- 7 days): Final assessment.
For the duration of the study, the patient will record in a notebook: analgesics, anti-inflammatories, corticoids and daily hand pain VAS.
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
- Double (Participant, Investigator)
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
- •Diagnosis of digital osteoarthritis fulfilling the American College of Rheumatology criteria;
- •Presence of finger pain of ≥ 40 mm on a visual analogue scale (VAS);
- •Presence of finger pain with a neuropathic pain component (DN4 score ≥ 4/10)
- •Inadequate response, adverse reactions, and/or contraindications to conventional analgesics and NSAIDs;
排除标准
- •Patient with isolated rhizarthrosis;
- •Patient with other joint disease affecting the fingers (gout, chondrocalcinosis, RA, spondyloarthritis, psoriatic arthritis);
- •Patient with upper extremity pain syndrome that may interfere with the assessment of finger pain;
- •Patient with another pathology responsible for neuropathic hand pain (carpal tunnel syndrome, diabetic neuropathy, Guyon's tunnel syndrome, cervicobrachial neuralgia, brachial plexitis);
- •Patient with skin lesions on the fingers (psoriasis, wounds, chronic ulcers, eczema, shingles, dermatitis);
- •Patient with poorly controlled high blood pressure;
- •Patient with hypersensitivity to capsaicin;
- •Patient who had 8% capsaicin patch use in the year prior to the study;
- •Patient who has received intramuscular, intra-articular or intravenous corticosteroid therapy, another disease-modifying anti-rheumatic therapy (methotrexate, salazopyrine) or an intra-articular injection into the joints of the fingers within the previous 3 months;
- •Patient wearing wrist or finger orthoses in the previous month;
- •Patient with fibromyalgia;
研究组 & 干预措施
Capsaicin 8%
patch 179 mg, 30 min
干预措施: Capsaicin 179 Mg Cutaneous Patch (Drug)
Capsaicin 0.04%
patch low dose, 30 min
干预措施: Capsaicine low dose 0.04 % (Drug)
结局指标
主要结局
Intensity of pain in the fingers
时间窗: Day 60
measured on a visual analogic scale ranging from 0 to 100 mm
次要结局
- Anxiety and depression(Day 60)
- Functional index(Day 60)
- Patient impression of change(Day 60)
- Functional disability(Day 60)
- Painful symptoms of osteoarthritis(Day 60)
- Treatment safety(Day 60)