CADOR (Capsaicin in neuropathic-like pain in digital osteoarthritis) study protocol: a multicentre randomised parallel-group trial.
Angelique Fan, Céline Lambert, Jeremie Sellam...
https://pubmed.ncbi.nlm.nih.gov/40050054Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID06444919
Capsaicin in Digital Osteoarthritis Versus Control: a Randomized Study
Led by University Hospital, Clermont-Ferrand · Updated on 2025-03-13
120
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospital, Clermont-Ferrand
Lead Sponsor
G
Grünenthal GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of a transdermal capsaicin patch in adults with digital osteoarthritis who also have neuropathic pain in their fingers. This randomized, double-blind clinical trial compares a high-dose capsaicin patch (179 mg, 8%) to a low-dose control patch (0.04%), aiming to see differences in finger pain intensity after 60 days. Participants receive either the high-dose or low-dose capsaicin patch applied to their painful fingers for 30 minutes during the initial visit. The study includes a screening visit, randomization and patch application, followed by a first follow-up visit at about 60 days where pain and function are assessed, and possibly a new high-dose patch application if pain remains high. A second follow-up visit at 120 days completes the study. Patients record daily pain levels and medication use throughout. During the study, researchers take blood samples at the beginning and at 60 days to measure inflammatory markers and cartilage degradation indicators. Participants undergo pain assessments, functional evaluations, and questionnaires on anxiety and depression. Safety and patient impressions of change are also monitored. The total study participation lasts approximately 120 days with regular visits and ongoing symptom tracking.
CONDITIONS
Brief Title
Capsaicin in Digital Osteoarthritis Versus Control
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of digital osteoarthritis meeting American College of Rheumatology criteria
- Finger pain of 40 mm or higher on a visual analogue scale (VAS)
- Finger pain with neuropathic component indicated by DN4 score 4 or higher
- Inadequate response, adverse reactions, or contraindications to conventional analgesics and NSAIDs
- Age 18 years or older
You will not qualify if you...
- Isolated rhizarthrosis
- Other joint diseases affecting fingers (gout, chondrocalcinosis, rheumatoid arthritis, spondyloarthritis, psoriatic arthritis)
- Upper extremity pain syndrome affecting finger pain assessment
- Other causes of neuropathic hand pain (carpal tunnel syndrome, diabetic neuropathy, Guyon's tunnel syndrome, cervicobrachial neuralgia, brachial plexitis)
- Skin lesions on fingers (psoriasis, wounds, ulcers, eczema, shingles, dermatitis)
- Poorly controlled high blood pressure
- Hypersensitivity to capsaicin
- Use of 8% capsaicin patch within past year
- Recent corticosteroid therapy or disease-modifying anti-rheumatic therapy within 3 months
- Wearing wrist or finger orthoses in past month
- Fibromyalgia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - Up to 30 days before enrollment
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 60 days
Participants are randomized to receive a blinded patch application of either capsaicin 8% or a low-dose capsaicin 0.04% patch applied for 30 minutes on the painful fingers.
1 baseline visit (in-person)
Treatment
Duration - Up to 7 days after Day 60
Participants receive a follow-up assessment and may have their patch renewed. Those with finger pain greater than 4/10 may receive an open application of capsaicin 8%.
1 follow-up visit (in-person)
Follow-up
Duration - Up to 7 days after Day 120
Participants undergo a final assessment to evaluate treatment outcomes.
1 final visit (in-person)
Trial Site Locations
Total: 4 locations
1
CHU de Clermont-Ferrand
Clermont-Ferrand, France
Actively Recruiting
2
HCL Hôpital Edouard Herriot
Lyon, France
Actively Recruiting
3
AP-HP Hôpital Saint-Antoine
Paris, France
Actively Recruiting
4
CHU de Saint-Etienne
Saint-Etienne, France
Actively Recruiting
Loading map...
Research Team
L
Lise Laclautre
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here