Capsaicin for Digital osteoarthritis | Finger osteoarthritis

Inclusion criteria

• {"criterion_text":"- age greater than or equal to 18 years\n- diagnosis of digital osteoarthritis according to the criteria of the American College of Rheumatology\n- presence of finger pain of intensity ≥ 40 mm on a VAS;\n- presence of finger pain with a neuropathic painful component (DN4 score ≥ 4/10\n- inadequate response, adverse effects and/or contraindication to traditional analgesics and NSAIDs;\n- able to read and understand study information\n- signed informed consent\n- affiliation to a social security scheme.\n- 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

• {"criterion_text":"- patient with isolated rhizarthrosis\n- patient with fibromyalgia according to the opinion of the investigating doctor;\n- pregnant or breastfeeding woman; (a urine pregnancy test will be carried out in women of childbearing age before any transdermal patch placement)\n- patient under guardianship or curatorship or deprived of liberty.\n- 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\n- patient with another pathology responsible for neuropathic hand pain (carpal tunnel syndrome, diabetic neuropathy, Guyon's canal syndrome, cervico-brachial neuralgia, brachial plexitis)\n- patient with skin lesions on the fingers (psoriasis, wounds, chronic ulcers, eczema, shingles, dermatitis)\n- patient with poorly controlled arterial hypertension\n- patient with hypersensitivity to capsaicin\n- patient having had an 8% capsaicin patch applied in the year before the study\n- 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\n- patient wearing wrist or finger orthoses in the previous month"}

Primary endpoints

• {"endpoint_text":"- Finger pain intensity at eight weeks (W8) measured on a VAS ranging from 0 to 100 mm.","definition_or_measurement_approach":"Measured using a visual analogue scale (VAS) ranging from 0 to 100 mm at week 8."}

France

Earliest CTIS Part Ii Submission Date

18-04-2024

Latest Decision Or Authorization Date

23-05-2024

Processing Time Days

35

Number Of Sites

4

Number Of Participants

120

Primary sponsor

Full Name

University Hospital Of Clermont-Ferrand

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"DGOS","duties_or_roles":"Source of monetary support","organisation_type":""}