Using capsaicin patches to treat painful hand osteoarthritis
Capsaicin in Digital Osteoarthritis Versus Control : a Randomized Study
This study is testing if a stronger capsaicin patch can help people with painful hand osteoarthritis feel less pain compared to a weaker version.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 4 sites (Clermont-Ferrand and 3 other locations) |
| Trial ID | NCT06444919 on ClinicalTrials.gov |
What this trial studies
This multicentric, randomized controlled double-blind clinical trial aims to evaluate the efficacy of a transdermal capsaicin patch (8%) compared to a lower dose (0.04%) in patients suffering from painful digital osteoarthritis with a neuropathic pain component. Participants will be randomly assigned to receive either the higher concentration capsaicin patch or the control patch, and their pain levels will be assessed at 60 days. The study will also involve monitoring the use of analgesics and measuring inflammatory markers through blood samples. The goal is to determine if the higher dose of capsaicin can significantly reduce pain compared to the lower dose.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with digital osteoarthritis who experience significant finger pain and have a neuropathic pain component.
Not a fit: Patients with isolated rhizarthrosis or other joint diseases affecting the fingers may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant pain relief for patients with digital osteoarthritis and neuropathic pain.
How similar studies have performed: Other studies have shown promise in using capsaicin for pain relief, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of digital osteoarthritis fulfilling the American College of Rheumatology criteria; * Presence of finger pain of ≥ 40 mm on a visual analogue scale (VAS); * Presence of finger pain with a neuropathic pain component (DN4 score ≥ 4/10) * Inadequate response, adverse reactions, and/or contraindications to conventional analgesics and NSAIDs; Exclusion Criteria: * Patient with isolated rhizarthrosis; * Patient with other joint disease affecting the fingers (gout, chondrocalcinosis, RA, spondyloarthritis, psoriatic arthritis); * Patient with upper extremity pain syndrome that may interfere with the assessment of finger pain; * Patient with another pathology responsible for neuropathic hand pain (carpal tunnel syndrome, diabetic neuropathy, Guyon's tunnel syndrome, cervicobrachial neuralgia, brachial plexitis); * Patient with skin lesions on the fingers (psoriasis, wounds, chronic ulcers, eczema, shingles, dermatitis); * Patient with poorly controlled high blood pressure; * Patient with hypersensitivity to capsaicin; * Patient who had 8% capsaicin patch use in the year prior to the study; * Patient who has received intramuscular, intra-articular or intravenous corticosteroid therapy, another disease-modifying anti-rheumatic therapy (methotrexate, salazopyrine) or an intra-articular injection into the joints of the fingers within the previous 3 months; * Patient wearing wrist or finger orthoses in the previous month; * Patient with fibromyalgia;
Where this trial is running
Clermont-Ferrand and 3 other locations
- CHU de Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
- HCL Hôpital Edouard Herriot — Lyon, France (Recruiting)
- AP-HP Hôpital Saint-Antoine — Paris, France (Recruiting)
- CHU de Saint-Etienne — Saint-Etienne, France (Recruiting)
Study contacts
- Principal investigator: Sylvain Mathieu — University Hospital, Clermont-Ferrand
- Study coordinator: Lise Laclautre
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: 334.73.754.963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.