Capsaicin in digital osteoarthritis versus control : a randomized study

INTERVENTION: Product Name: capsaïcine 0.04 %,Product Code: N/A,Pharmaceutical Form: N/A,Other descriptive name: N/A,Strength: N/A,Pharmaceutical form of the placebo: N/A,Product Name: Qutenza 179 mg cutaneous patch,Product Code: PRD4980580,Pharmaceutical Form: CUTANEOUS PATCH,Other descriptive name: ,Strength: Capsaicin 179mg CONDITION: digital osteoarthritis ; MedDRA version: 21.1Level: LLTClassification code: 10016686Term: Finger osteoarthritisSystem Organ Class: 10028395 MedDRA version: 21.1Level: LLTClassification code: 10016686Term: Finger osteoarthritisSystem Organ Class: 10028395 Therapeutic area: Diseases [C] ‐ Musculoskeletal Diseases [C05] PRIMARY OUTCOME: Main Objective:Compare the effectiveness at 8 weeks (W8) of the transdermal application of capsaicin 8% to that of a control (low dose capsaicin at 0.04%) on finger pain, in patients with painful digital osteoarthritis with a neuropathic pain component. Primary end point(s):Finger pain intensity at eight weeks (W8) measured on a VAS ranging from 0 to 100 mm. Secondary Objective:Compare the effectiveness at W8 of the transdermal application of capsaicin 8% to that of capsaicin 0.04% on: ? functional disability; ? quality of life; ? anxiety and depression; ? the number of arthralgias and clinical synovitis; ? the intensity of the pain concerning the most painful finger; ? disease activity according to the patient; ? the percentage of improvement in pain in the most painful finger; ? the “Patient Global Impression of Change” (PGIC) global improvement score; ? painful symptoms of osteoarthritis; ? the level of ultrasensitive C‐reactive protein (CRPus); ? the value of inflammatory and cartilage degradation biomarkers; ? consumption of analgesics and anti‐inflammatories.,Evaluate the tolerance of the treatment.,To study the effect of transdermal application of capsaicin 8% on the weekly evolution of pain compared to transdermal application of capsaicin 0.04%.,Compare the effectiveness at 16 weeks (W16) of two transdermal applications of capsaicin 8% (eight weeks apart) to a single transdermal application of capsaicin 8% on finger pain 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