Capsaicin in Digital Osteoarthritis Versus Control
Recruiting · NCT06444919 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Clermont-Ferrand
View the official record on ClinicalTrials.gov →Interventions studied
Capsaicin 179 Mg Cutaneous PatchCapsaicine low dose 0.04 %
What this trial is about
The objective of this multicentric, randomized controlled double-blind clinical trial is to demonstrate the efficacy of transdermal application of capsaicin in patients with painful digital osteoarthritis with a neuropathic pain component. Participants will receive either a transdermal patch of capsaicin 179 mg (8%) or the control treatment (capsaicin 0.04%). Researchers will compare the intensity of pain in the fingers at day 60 in the capsaicin 8% group versus capsaicin 0.04% (control arm)
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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 it is running
4 locations listed.
- CHU de Clermont-Ferrand - Clermont-Ferrand, France
- HCL Hôpital Edouard Herriot - Lyon, France
- AP-HP Hôpital Saint-Antoine - Paris, France
- CHU de Saint-Etienne - Saint-Etienne, France