Actively Recruiting
Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia.
Led by Nantes University Hospital · Updated on 2026-02-24
188
Participants Needed
6
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective is to demonstrate the analgesic effect at day 60 of 8% capsaicin patch (Qutenza) for the treatment of patients with coccygodyinia.
CONDITIONS
Official Title
Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years at pre-inclusion visit
- Chronic coccygodynia with pain in the tailbone region lasting more than 3 months
- Pain intensity of 4 or higher on a 0 to 10 scale over the last ten days
- Previous treatments with NSAIDs, pressure cushions, or infiltration have failed, are contraindicated, or refused
- No prior treatment with 8% capsaicin patch for this condition
- At least one clinical sign of neuropathic pain such as burning, painful cold, numbness, tingling, electric discharge, or allodynia near the coccyx
- Ability to read and write French
- Affiliated with the social security system
- Signed informed consent form
- Women must use effective contraception with negative pregnancy test, be post-menopausal, have documented amenorrhoea with hormonal levels indicating menopause, or have had irreversible surgical sterilization
You will not qualify if you...
- Coccygodynia with skin lesions in the intergluteal cleft (psoriasis, pilonidal cyst, wound)
- Other major pain disorders interfering with pain assessment
- Hypersensitivity to capsaicin or excipients
- Adults under legal protection (guardianship, curatorship)
- Pregnant or breastfeeding women
- Patients who have had total coccygectomy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Brest University Hospital
Brest, France
Actively Recruiting
2
Vendée Departmental Hospital
La Roche-sur-Yon, France
Actively Recruiting
3
Confluent Private Hospital Centre
Nantes, France
Actively Recruiting
4
Nantes University Hospital
Nantes, France
Actively Recruiting
5
GH Paris saint Joseph
Paris, France
Actively Recruiting
6
Rouen University Hospital
Rouen, France
Actively Recruiting
Research Team
A
Amélie LEVESQUE, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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