Capsaicin in Digital Osteoarthritis Versus Control
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Clermont-Ferrand
About this trial
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)
Eligibility criteria
Qualifiers
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;
Disqualifiers
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);
Trial design
Treatments tested in this trial
- Capsaicin 179 Mg Cutaneous Patch
- Capsaicine low dose 0.04 %
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
University Hospital, Clermont-Ferrand
Lead sponsor
Grünenthal GmbH
Collaborator
Source ClinicalTrials.gov