Clinical trial
Capsaicin in Digital Osteoarthritis Versus Control : a Randomized Study
Name
PHRC IR 2022 MATHIEU
Description
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)
Trial arms
Trial start
2024-09-01
Estimated PCD
2028-01-01
Trial end
2028-01-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Capsaicin 179 Mg Cutaneous Patch
patch application for 30 minutes on the painful fingers.
Arms:
Capsaicin 8%
Other names:
QUTENZA
Capsaicine low dose 0.04 %
patch application for 30 minutes on the painful fingers. the low-dose patch has a similar appearance to the active patch. It allows you to keep the blind, because it also causes reactions at the capsaicin application site (erythema, burning).
Arms:
Capsaicin 0.04%
Other names:
control treatment
Size
120
Primary endpoint
Intensity of pain in the fingers
Day 60
Eligibility 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;
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}
Updated at
2024-06-06
1 organization
1 product
2 indications
Organization
University Hospital Clermont-FerrandProduct
CapsaicinIndication
Osteoarthritis of the HandIndication
Neuropathic Pain