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卡多 (Capsaicin in neuropathic-like pain in digital osteoarthritis) 研究协议:一个多中心随机并行组试验
Angelique Fan1, Céline Lambert2, Jeremie Sellam3,4
1Department of Rheumatology, CHU Clermont-Ferrand, Clermont-Ferrand, France.
BMJ open
|March 6, 2025
概括
这项研究研究了8%的素通过皮肤贴片用于手骨关节炎 (HOA) 中的神经病样疼痛. 该试验将高剂量的素与低剂量的对照剂量进行比较,以评估疼痛缓解和功能改善.
科学领域:
- 类风湿病学 类风湿病学
- 疼痛管理 疼痛管理
- 皮肤病学 皮肤病学
背景情况:
- 手部骨关节炎 (HOA) 经常涉及神经病变性疼痛,这种疼痛由NSAIDs和常规止痛药管理得很差.
- 从中提取的素是局部神经病痛的批准治疗方法.
- 在随机试验中没有评估8%的素通过皮肤贴片对神经性疼痛的HOA的疗效.
研究的目的:
- 在患有疼痛数字HOA和神经病态类疼痛的患者中,比较8%素透皮贴片的60天疗效与0.04%素对照剂.
- 评估疼痛强度,功能障碍,生活质量和心理影响.
主要方法:
- CADOR是一个第三期多中心,随机,受控,双盲试验,涉及120名患有HOA和神经病样疼痛的患者 (DN4评分≥4/10).
- 患者接受一次8%或0.04%素透皮贴片的局部应用.
- 主要结局是第60天的手指疼痛强度,用视觉模拟尺度 (VAS) 测量. 二次结果包括功能障碍,生活质量和安全.
主要成果:
- 主要结局是60日过去48小时的疼痛强度,用VAS (0-100毫米) 测量.
- 二次结果包括功能障碍,生活质量,焦虑,抑郁,患者对改善的总体印象,止痛药的使用和安全性.
- 两种应用的有效性将在第120天进行评估.
结论:
- 这项试验将提供关键数据,关于8%的素通过皮肤贴片的疗效和安全性,用于管理手部骨关节炎中神经病状疼痛.
- 研究结果将为这一具有挑战性的患者群体提供临床实践和治疗指导方针.
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