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0 至 18 岁儿童使用 8% 辣椒素贴剂的观察性研究 (CAPSULE)

2026年7月29日更新者：University Hospital, Brest

在常规医疗保健中接受经过验证的 8% 辣椒素贴剂治疗的年龄小于 18 岁的患者将被提供参与该研究。如果他们和他们的父母一样接受，他们将被纳入研究。

医疗数据将被记录下来，在家里，孩子或其家人将收集疼痛评估数据。

调查小组每 24 小时通过电话在家中监测耐受性，直至正常化。（75% 少于 24 小时，未发表的个人系列为 100% 到 72 小时。）儿童将在纳入时以及 1 个月、3 个月和 6 个月时通过量表进行评估。

研究概览

地位

主动，不招人

条件

干预/治疗

其他：数据采集

详细说明

患有慢性局部神经性疼痛的 18 岁以下儿童和青少年可以使用 8% 辣椒素贴剂进行治疗。如果该适应症在儿科慢性疼痛咨询中得到验证，他们将被邀请参加该研究。如果他们和他们的父母一样接受它，他们将被纳入研究。

治疗应用将遵循建议，并在训练有素的护士的门诊进行。

研究小组将每 24 小时通过电话评估耐受性，直至正常化。根据未公开的个人数据，75% 患者的预期持续时间少于 24 小时，72 小时时为 100%。

应用一个月后，将使用适合年龄和认知能力的常用疼痛和神经性疼痛工具监测疗效。

如果需要，可以进行三次治疗，每次使用辣椒素贴片之间的间隔为三个月。

研究类型

观察性的

注册 (估计的)

160

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

法国
- - Amiens、法国、80054
    - CHU d'Amiens
  - Lyon、法国
    - Chu Lyon
- France
  - Angers、France、法国、49933
    - CHU Angers
  - Bordeaux、France、法国、33076
    - CHU Bordeaux
  - Bourg-en-Bresse、France、法国、01000
    - CHR Bourg en Bresse
  - Brest、France、法国、29609
    - CHU de Brest
  - Caen、France、法国、14000
    - CHU Caen
  - Lille、France、法国、59037
    - CHU Lille
  - Limoges、France、法国、87042
    - CHU Limoges
  - Marseille、France、法国、13005
    - CHU Marseille
  - Montpellier、France、法国、34090
    - CHU Montpellier
  - Nancy、France、法国、54511
    - CHU Nancy
  - Nantes、France、法国、44093
    - CHU Nantes
  - Paris、France、法国、75019
    - CHU Robert Debre
  - Paris、France、法国、75571
    - CHU Trousseau
  - Rouen、France、法国、76031
    - CHU Rouen
  - Strasbourg、France、法国、67098
    - CHRU Strasbourg
  - Toulouse、France、法国、31059
    - CHU Toulouse
  - Tours、France、法国、37044
    - CHU Tours
  - Villejuif、France、法国、94805
    - Institut Gustave Roussy

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

不超过 17年 (孩子)

接受健康志愿者

不

取样方法

非概率样本

研究人群

18 岁以下慢性局部神经性疼痛患者和 8% 辣椒素贴剂适应症在儿科慢性疼痛中心得到验证。

接受智力发育障碍患者

描述

纳入标准：

慢性局部神经性疼痛
8% 辣椒素贴片治疗适应症在儿科慢性疼痛中心得到验证
儿童和家长参与协议

排除标准：

已在同一身体区域使用 8% 辣椒素贴剂进行治疗
已经在其他研究中心的同一项研究中接受过治疗
不愿意参加或父母不愿意参加研究

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

观测模型：仅案例
时间观点：预期

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Success or failure of pain treatment 大体时间：6 months after last patch application	The success is defined by the absence of use of pharmacological or non-pharmacological treatments taken for pain relief or to improve comfort, including to aid sleep, 6 months after capsaicin last patch application. The list of treatments is defined as follows: antiepileptic drug, tricyclic antidepressant, SNRI antidepressant, weak opioids, strong opioids, other pharmacological treatments, non-pharmacological pain-related devices.	6 months after last patch application

次要结果测量

结果测量	措施说明	大体时间
Use of pharmacological treatment 大体时间：Baseline	Use (yes/no) of at least one of these pharmacological treatments : antiepileptic, tricyclic antidepressant, SNRI antidepressant, weak opioid, strong opioid, other pharmacological treatment.	Baseline
Use of pharmacological treatment 大体时间：6 months after last patch application	Use (yes/no) of at least one of these pharmacological treatments : antiepileptic, tricyclic antidepressant, SNRI antidepressant, weak opioid, strong opioid, other pharmacological treatment.	6 months after last patch application
Use of antiepileptic treatment 大体时间：Baseline	Use of antiepileptic treatment (yes/no).	Baseline
Use of antiepileptic treatment 大体时间：6 months after last patch application	Use of antiepileptic treatment (yes/no).	6 months after last patch application
Use of tricyclic antidepressant treatment 大体时间：Baseline	Use of tricyclic antidepressant treatment (yes/no).	Baseline
Use of tricyclic antidepressant treatment 大体时间：6 months after last patch application	Use of tricyclic antidepressant treatment (yes/no).	6 months after last patch application
Use of SNRI antidepressant treatment 大体时间：Baseline	Use of SNRI antidepressant treatment (yes/no).	Baseline
Use of SNRI antidepressant treatment 大体时间：6 months after last patch application	Use of SNRI antidepressant treatment (yes/no).	6 months after last patch application
Use of weak opioid treatment 大体时间：Baseline	Use of weak opioid treatment (yes/no).	Baseline
Use of weak opioid treatment 大体时间：6 months after last patch application	Use of weak opioid treatment (yes/no).	6 months after last patch application
Use of strong opioid treatment 大体时间：Baseline	Use of strong opioid treatment (yes/no).	Baseline
Use of strong opioid treatment 大体时间：6 months after last patch application	Use of strong opioid treatment (yes/no).	6 months after last patch application
Use of other pharmacological treatment 大体时间：Baseline	Use of other pharmacological treatment (yes/no)	Baseline
Use of other pharmacological treatment 大体时间：6 months after last patch application	Use of other pharmacological treatment (yes/no)	6 months after last patch application
Use of non-pharmacological treatment 大体时间：Baseline	Use (yes/no) of at least one of these non-pharmacological treatments : limitation of rubbing, mobility aid, restriction of movement, use of adapted tools, other non-pharmacological treatment.	Baseline
Use of non-pharmacological treatment 大体时间：6 months after last patch application	Use (yes/no) of at least one of these non-pharmacological treatments : limitation of rubbing, mobility aid, restriction of movement, use of adapted tools, other non-pharmacological treatment.	6 months after last patch application
Use of pharmocological or non-pharmacological treatment 大体时间：Baseline	Use (yes/no) of at least one of these treatments : antiepileptic, tricyclic antidepressant, SNRI antidepressant, weak opioid, strong opioid, other pharmacological treatment, limitation of rubbing, mobility aid, restriction of movement, use of adapted tools, other non-pharmacological treatment.	Baseline
Use of pharmocological or non-pharmacological treatment 大体时间：6 months after last patch application	Use (yes/no) of at least one of these treatments : antiepileptic, tricyclic antidepressant, SNRI antidepressant, weak opioid, strong opioid, other pharmacological treatment, limitation of rubbing, mobility aid, restriction of movement, use of adapted tools, other non-pharmacological treatment.	6 months after last patch application
Indication of capsaicin use 大体时间：Baseline	Indication for treatment with capsaicin will be collected (context of emergence of pain).	Baseline
Erythema 大体时间：Baseline	Presence of erythema up to 120 hours after patch application (yes/no).	Baseline
Erythema 大体时间：Month 3 if applicable	Presence of erythema up to 120 hours after patch application (yes/no).	Month 3 if applicable
Erythema 大体时间：Month 6 if applicable	Presence of erythema up to 120 hours after patch application (yes/no).	Month 6 if applicable
Cooling 大体时间：Baseline	Use of cooling up to 120 hours after patch application (yes/no).	Baseline
Cooling 大体时间：Month 6 if applicable	Use of cooling up to 120 hours after patch application (yes/no).	Month 6 if applicable
Cooling 大体时间：Month 3 if applicable	Use of cooling up to 120 hours after patch application (yes/no).	Month 3 if applicable
Duration of cooling 大体时间：Baseline	Duration of cooling is defined according to the first time point at which cooling is permanently discontinued. (Example: if cooling is permanently discontinued at 48 hours, the duration of cooling is classified as "Less than 48 hours").	Baseline
Duration of cooling 大体时间：Month 3 if applicable	Duration of cooling is defined as the first time point at which cooling is permanently discontinued. (Example: if cooling is permanently discontinued at 48 hours, the duration of cooling is classified as "Less than 48 hours").	Month 3 if applicable
Duration of cooling 大体时间：Month 6 if applicable	Duration of cooling is defined as the first time point at which cooling is permanently discontinued. (Example: if cooling is permanently discontinued at 48 hours, the duration of cooling is classified as "Less than 48 hours").	Month 6 if applicable
Change in continuous pain 大体时间：Baseline and 6 months after last patch application	Continuous pain will be measured with VAS (Visual Analogic Scale), paediatric VAS, NS (Numerical Scale) or Revised Faces Pain Scales depending on patient age. All ranges from 0 to 10. Higher score is worse outcome.	Baseline and 6 months after last patch application
Change in intermittent pain 大体时间：Baseline and 6 months after last patch application	Intermittent pain will be measured with VAS (Visual Analogic Scale), paediatric VAS, NS (Numerical Scale) or Revised Faces Pain Scales depending on patient age. All ranges from 0 to 10. Higher score is worse outcome.	Baseline and 6 months after last patch application
Condition assessment 大体时间：Baseline	DN4 questionnaire score. The score ranges from 0 to 10, with 10 indicating the worst outcome.	Baseline
Condition assessment 大体时间：Baseline	NPSI questionnaire global score. The global score ranges from 0 to 100, with 100 indicating the worst outcome.	Baseline
Condition assessment 大体时间：Baseline	NPSI questionnaire first subscore (superficial spontaneous pain). The subscore ranges from 0 to 10, with 10 indicating the worst outcome.	Baseline
Condition assessment 大体时间：Baseline	NPSI questionnaire second subscore (deep spontaneous pain). The subscore ranges from 0 to 10, with 10 indicating the worst outcome.	Baseline
Condition assessment 大体时间：Baseline	NPSI questionnaire third subscore (paroxysmal pain). The subscore ranges from 0 to 10, with 10 indicating the worst outcome.	Baseline
Condition assessment 大体时间：Baseline	NPSI questionnaire forth subscore (evoked pain). The subscore ranges from 0 to 10, with 10 indicating the worst outcome.	Baseline
Condition assessment 大体时间：Baseline	NPSI questionnaire fifth subscore (paresthesia / dysesthesia). The subscore ranges from 0 to 10, with 10 indicating the worst outcome.	Baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University Hospital, Brest

合作者

Fondation Apicil

Fondation de France

调查人员

首席研究员：Philippe J Le Moine, MD、CHRU of Brest

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年5月12日

初级完成 (估计的)

2027年5月1日

研究完成 (估计的)

2027年9月1日

研究注册日期

首次提交

2021年12月23日

首先提交符合 QC 标准的

2022年3月17日

首次发布 (实际的)

2022年3月29日

研究记录更新

最后更新发布 (实际的)

2026年7月30日

上次提交的符合 QC 标准的更新

2026年7月29日

最后验证

2026年7月1日