NCT05817591招募中不适用
Response Profiles to High-concentration Capsaicin Desensitization in Patients with Peripheral Neuropathic Pain with or Without Allodynia: a Regional Multicenter Prospective Cohort
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 10
- 主要终点
- Factors (profiles) associated with a better initial response to pain desensitization by capsaicin
研究概览
简要总结
Prospective multicenter cohort to determine patient profiles (associated factors, including allodynia) with a better response to pain desensitization by capsaicin delivered in the form of a high concentration patch (8%), in a population of patients with peripheral neuropathic pain and followed up in a pain consultation in the Auvergne Rhône Alpes region.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient over 18 years of age on the day of inclusion
- •Patient who has been informed and has not expressed opposition to participating in the study,
- •Patient with peripheral neuropathic pain (whatever the etiology), defined by :
- •"Neuropathic Pain 4" score ("DN4" score) ≥ 4/10
- •AND pain according to the numerical scale (EN) > 4/10,
- •AND stable analgesic treatment for at least 1 month,
- •AND with or without mechanical allodynia according to the Quantitative Sensory Testing (QST) : Brush test (dynamic), Von Frey test (static)
- •AND with or without thermal allodynia to hot or cold as determined by a ROLLTEMP-II® (Rolltemp is a device designed for quick screening of temperature sensibility over large body areas).
- •Patient responding to an indication of desensitization to high concentration capsaicin concentration and not presenting any contra-indication.
- •Patient naïve of high concentration of Capsaicin on the concerned zone
- •Patient understanding French
- •Non-inclusion Criteria:
- •Patient with pain related to complex regional pain syndrome (criteria not meeting the indication for capsaicin)
- •Patient with active cancer (underlying disease and treatments may modify pain perception),
- •Patient receiving or having received in the last 3 months Botulinum toxin A on the concerned area (this treatment of neuropathic pain may modulate the effect of capsaicin and disturb the demonstration of causality),
- •Patient with planned surgery within the next 12 months on the painful site (surgery may cause neuropathic damage and/or bias the pain assessment),
- •Patient included in an interventional research protocol,
- •Patient under guardianship or curators,
- •Patient under legal protection
排除标准
- 未提供
结局指标
主要结局
Factors (profiles) associated with a better initial response to pain desensitization by capsaicin
时间窗: 12 months
A patient is a responder if he has a reduction in pain, as measured by a numerical pain scale, of at least 30% from baseline. The scale used is "EN - échelle numérique" in french, "NRS - Numerical Rating Scale" in english, between 0 and 10 (0 being the absence of pain and 10 the most intense pain).
次要结局
- Distribution of NPSI subscores values (Q8, Q9, Q10) over time: at inclusion, 3 months, 6 months, 9 months,12 months, and between inclusion and the end of follow-up(Each 3 months and over 12 months)
- Proportion [95% Confidence Interval (CI)] of patients "responder at 30%" at 1.5 months after each consecutive patch (e.g. at M4.5 for a second patch applied at M3)(1.5 months after each consecutive patch)
- Proportion [95% CI] of patients "initial responder" at 50%(12 months)
- Number of new initiation of analgesic treatment, defined by the addition of a molecule to the treatment given at the time of application of the first capsaicin patch(12 months)
- Distribution of Neuropathic Pain Symptom Inventory (NPSI) score values over time: at inclusion, 3 months, 6 months, 9 months,12 months, and between inclusion and the end of follow-up(Each 3 months and over 12 months)
- In the subpopulation of initial responders at the 30% threshold: proportion [95% CI] of patients relapsing at 12 months, defined as pain scale (EN) > 4/10, indicating a new capsaicin patch(12 months)
- Distribution of Patients' Global Impression of Change (PGIC) scale score values over time: at 1.5 months, 3 months, 4.5 months, 6 months, 7.5 months, 9 months,10.5 months, 12 months, and between inclusion and the end of follow-up(Each 1.5 months and over 12 months)
- In the subpopulation of patients with allodynia (dynamic mechanical or static or thermal): proportion [95% CI] of "responders" at 7.5 months(7.5 months)
- Number of reduction of analgesic treatment, defined by the stop of a molecule compared to the treatment given at the time of the application of the first capsaicin patch(12 months)
研究者
研究点 (10)
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