Actively Recruiting
Response Profiles to High-concentration Capsaicin Desensitization in Patients with Peripheral Neuropathic Pain with or Without Allodynia: a Regional Multicenter Prospective Cohort
Led by Centre Hospitalier Annecy Genevois · Updated on 2025-02-13
400
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating patient profiles to understand which factors, including allodynia, are linked to a better response to pain relief using a high concentration (8%) capsaicin patch in people with peripheral neuropathic pain. This regional multicenter prospective cohort study follows patients treated in pain clinics across the Auvergne Rhône Alpes region. All participants will receive routine care involving three applications of the 8% capsaicin patch applied locally for 30 to 60 minutes every three months at months 0, 3, and 6, or until their pain score drops below 4 out of 10. Pain levels are assessed every 1.5 months to monitor response, and additional patches may be provided if pain rises above 4 out of 10 after a response. Participants will complete pain monitoring questionnaires including the Neuropathic Pain Symptom Inventory (NPSI) and Patients' Global Impression of Change (PGIC) scale at regular intervals throughout the 12-month follow-up. Researchers will measure factors associated with better initial pain desensitization response and track outcomes such as pain relief, relapse, and changes in pain medication use over time.
CONDITIONS
Brief Title
Response Profiles to High-concentration Capsaicin Desensitization in Patients with Peripheral Neuropathic Pain with or Without Allodynia: a Regional Multicenter Prospective Cohort
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 defined by Neuropathic Pain 4 (DN4) score 4/10
- Pain score above 4/10 on the numerical scale (EN)
- Stable analgesic treatment for at least 1 month
- With or without mechanical allodynia as determined by Quantitative Sensory Testing (brush and Von Frey tests)
- With or without thermal allodynia to hot or cold as determined by ROLLTEMP-II4 device
- Patient indicated for high concentration capsaicin desensitization and without contraindications
- Patient naive to high concentration capsaicin on the concerned zone
- Patient understanding French
You will not qualify if you...
- Pain related to complex regional pain syndrome
- Active cancer
- Receiving or having received botulinum toxin A on the concerned area within the last 3 months
- Planned surgery within the next 12 months on the painful site
- Participation in another interventional research protocol
- Under guardianship, curatorship, or legal protection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants who undergo routine care with high-concentration capsaicin patches are observed to evaluate their pain response and treatment effects.
Visits every 1.5 months for pain assessment and questionnaires
Trial Site Locations
Total: 10 locations
1
Centre Hospitalier Annecy Genevois
Annecy, France, 74370
Actively Recruiting
2
Hospices Civils de Lyon, Hôpital Pierre Wertheimer
Bron, France, 69500
Not Yet Recruiting
3
Centre Hospitalier Métropole Savoie
Chambéry, France, 73000
Actively Recruiting
4
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, France, 63000
Not Yet Recruiting
5
Centre Hospitalier Universitaire Grenoble-Alpes
Grenoble, France, 38043
Actively Recruiting
6
Hospices Civils de Lyon, Hôpital de la Croix Rousse
Lyon, France, 69317
Not Yet Recruiting
7
Centre Léon Bérard
Lyon, France, 69373
Actively Recruiting
8
Centre Hospitalier Universitaire de Saint-Etienne
Saint-Etienne, France, 42055
Not Yet Recruiting
9
Clinique Mutualiste Chirurgicale de Saint Etienne
Saint-Etienne, France, 42100
Actively Recruiting
10
Médipôle Lyon Villeurbanne
Villeurbanne, France, 69100
Not Yet Recruiting
Research Team
M
Marion GHIDI
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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