Capsaicin in Digital Osteoarthritis Versus Control
brief summary
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)
detailed description
Visit 0 : Screening visit (D0 - 30 days): Screen for eligibility
Visit 1 :Inclusion visit (D0): Randomization and blinded patch application of capsaicin 8% or 0.04%
Visit 2: Follow-up visit 1 (D60 + 7 days): Assessment +/- Patch renewal. Patients with finger pain still greater than 4/10 may receive an open application of a capsaicin 8%
Visit 3:Follow-up visit 2 (D120 +/- 7 days): Final assessment.
For the duration of the study, the patient will record in a notebook: analgesics, anti-inflammatories, corticoids and daily hand pain VAS.
Blood samples will be taken at V1 and V2 for subsequent measurement of pro-inflammatory cytokines (IL6, IL8, TNFa) and markers of cartilage degradation, in order to build up a serum library.
official title
Capsaicin in Digital Osteoarthritis Versus Control : a Randomized Study