CAPSAPED
- Conditions
- Chronic postchirurgical or post-traumatic neuropathic painMedDRA version: 21.0Level: LLTClassification code: 10054095Term: Neuropathic pain Class: 10029205Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 46
Children aged 12 to 17 years (lower age limit of 12 has been chosen to ensure NPSI full filling), Male or female., Persistent neuropathic pain more than 32 months after surgery or trauma despite treatment following recommendations, Neuropathic pain is defined as a DN4 score equal to or greater than 3/7 or 4/10, and localized in a nerve territory explained by the surgery or the trauma, Treatment, survey and follow up must be realized in an identified investigating center of the study.
Intellectual deficiency not allowing full filling of NPSI., Insuffisant command of the French language to full fill NPSI and other evaluation tools., Parents’ refusal of consent., Underlying neurological disease., Ongoing neurotoxic treatment., Already treated by capsaicin., Cutaneous lesion on pain area.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To prove analgesic effectiveness of capsaicin 8% cutaneous patch in chronic postsurgical or post-traumatic neuropathic pain in children aged 12 to 17-y. Improvement of Neuropathic Pain Symptom Inventory (NPSI) score will be evaluated before the first application of capsaicin or placebo and 4 months later, after one or two applications.;Secondary Objective: Evaluation of tolerance and safety, during application and in the following days., Evaluation of analgesic effectiveness with NPSI, Evaluation of subscores of NPSI., Evaluation of improvement in function with Functional Disability Inventory (FDI)., Impact of topical capsaicin treatment on concomitant pain medication and non pharmacologic pain therapies.;Primary end point(s): Difference in Neuropathic Pain Symptom Inventory score evaluated between the first application (M0) of capsaicin or placebo and 4 months later (M4).
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Adverse event monitoring are collected during patch application and by phone calls in the following days.;Secondary end point(s):Vital signs including cardiac frequency and arteriel pressure.;Secondary end point(s):Physical examination including dermal assessment;Secondary end point(s):Intake of rescue medication against pain (YES/NO);Secondary end point(s):Duration of patch application;Secondary end point(s):Global score and subscores of NPSI (Neuropathic Pain Syndrome Inventory) questionnaire without support, score from 0 to 100, higher score is worse outcome;Secondary end point(s):Global score of FDI (Functional Disability Inventory) questionnaire, score from 0 to 60, higher score is worse outcome