Neuropathic Pain Clinical Trial
— CADOROfficial title:
Capsaicin in Digital Osteoarthritis Versus Control : a Randomized Study
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)
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | January 1, 2028 |
Est. primary completion date | January 1, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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; |
Country | Name | City | State |
---|---|---|---|
France | CHU de Clermont-Ferrand | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand | Grünenthal GmbH |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intensity of pain in the fingers | measured on a visual analogic scale ranging from 0 to 100 mm | Day 60 | |
Secondary | Functional disability | Cochin Hand Functional Disability Scale score, Each question is rated from 0 (no difficulty) to 5 (impossible). Total score for 18 questions: 0 - 90. The higher the score, the more impaired the physical function. | Day 60 | |
Secondary | Functional index | Modified Functional Index for Hand OsteoArthritis score (FIHOA), Each question is rated from 0 (no difficulty) to 3 (impossible). Total score for the 10 questions: 0 - 30. The higher the score, the greater the functional disability. | Day 60 | |
Secondary | Anxiety and depression | Hospital Anxiety and Depression Scale score (HADs), Each question is scored from 0 to 3. Total score for the 7 anxiety or depression questions: 0-21. The higher the score, the more anxious or depressed the patient. | Day 60 | |
Secondary | Painful symptoms of osteoarthritis | Osteoarthritis Symptom Inventory Scale score (OASIS9). Localized pain component = 4 questions rated from 0 (no sensation) to 10 (extreme sensation) score = 0-40.
Neuropathic pain component = 2 questions rated from 0 to 10 score = 0-20. Deep pain component = 3 questions rated from 0 to 10 score = 0-30. Total OASIS score: 0-90. A high score indicates intense pain. |
Day 60 | |
Secondary | Treatment safety | side effect rate | Day 60 | |
Secondary | Patient impression of change | Patient Global Impression of Change " (PGIC) score. The patient evaluates the degree of improvement of his pain
- Strongly improved - Moderately improved - Slightly improved - No change - Slightly worsened - Moderately worsened - Strongly worsened |
Day 60 |
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