跳至主要内容
临床试验/NCT05983263
NCT05983263招募中不适用

Neuropathic Determining Factors and Analgesic Efficacy of Capsaicin 8% (QUTENZA®) Patches in Refractory Coccygodygnia

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2023年11月8日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
106
试验地点
1
主要终点
Responder rate

研究概览

简要总结

A retrospective study over a period of 6 years to explore analgesic efficacy of 8% Capsaicin patch (QUTENZA®) in coccygodynic patients, as well as neuropathic predictive factors of therapeutic response.

详细描述

Coccygodynia corresponds to a localized pain in the coccyx region, aggravated or triggered by sitting and/or by getting up from a seat. Even if there is no epidemiology of this pain in France, coccygodynia represents a frequent recourse to specialized consultations (Rheumatology or Algology). Currently in France, there is no recommendation on the management of chronic disabling coccygodynia. Treatments are proposed in accordance with known/presumed underlying pathophysiology. Anti-inflammatory drugs and manual therapy (pressure relief cushions) are thus always offered as first-line treatments. But despite their common use/prescription, their efficacy is variable, with low level of evidence. More over, upstream of invasive coccygectomy, therapeutic arsenal is largely deficient, inviting to explore new approaches. Considering frequent neuropathic expression in coccygodynic pain pattern (tingling, itching, pain cold sensation…), capsaïcine 8% patch (QUTENZA®) are often performed. And in the same way, no/few researches tried to measure real-life analgesic pain efficacy of QUTENZA® strategy. Observational retrospective study (non-interventional anonymized data) CAPSACOXp aims to assess analgesic efficacy of Capsaicin 8% patch (QUTENZA®) and explore possible neuropathic determinants of therapeutic response in coccygodynia.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who received topical Capsaicin 8% patch therapy for the treatment of their coccygodygnia between August 2016 and August 2022

排除标准

  • Patients who have already received 8% Capsaicin patch topical treatment in coccyx area.

结局指标

主要结局

Responder rate

时间窗: 3 months after the inclusion visit.

Success defined by PGIC ≤ 2.

次要结局

  • Therapeutic response neuropathic predictive factors(3 months after the inclusion visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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