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Capsaicin in digital osteoarthritis versus control : a randomized study

Phase 1
Conditions
digital osteoarthritis
MedDRA version: 21.1Level: LLTClassification code: 10016686Term: Finger osteoarthritis Class: 10028395
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Registration Number
CTIS2024-511159-16-00
Lead Sponsor
niversity Hospital Of Clermont-Ferrand
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
120
Inclusion Criteria

age greater than or equal to 18 years, diagnosis of digital osteoarthritis according to the criteria of the American College of Rheumatology, presence of finger pain of intensity = 40 mm on a VAS;, presence of finger pain with a neuropathic painful component (DN4 score = 4/10, inadequate response, adverse effects and/or contraindication to traditional analgesics and NSAIDs;, able to read and understand study information, signed informed consent, affiliation to a social security scheme., Women of childbearing age must use effective contraception (pill, contraceptive implant, IUD, condoms or tubal ligation) for the entire duration of the trial

Exclusion Criteria

patient with isolated rhizarthrosis, patient with fibromyalgia according to the opinion of the investigating doctor;, pregnant or breastfeeding woman; (a urine pregnancy test will be carried out in women of childbearing age before any transdermal patch placement), patient under guardianship or curatorship or deprived of liberty., patient with another joint disease affecting the fingers (gout, chondrocalcinosis, RA, spondyloarthritis, psoriatic arthritis); ? patient with upper limb pain syndrome which could interfere with the assessment of finger pain, patient with another pathology responsible for neuropathic hand pain (carpal tunnel syndrome, diabetic neuropathy, Guyon's canal syndrome, cervico-brachial neuralgia, brachial plexitis), patient with skin lesions on the fingers (psoriasis, wounds, chronic ulcers, eczema, shingles, dermatitis), patient with poorly controlled arterial hypertension, patient with hypersensitivity to capsaicin, patient having had an 8% capsaicin patch applied in the year before the study, patient having received intramuscular, intra-articular or intravenous corticosteroid therapy, another basic anti-rheumatic treatment (methotrexate, salazopyrine) or an intra-articular injection into the finger joints in the previous three months, patient wearing wrist or finger orthoses in the previous month

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
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