Capsaicin in Digital Osteoarthritis Versus Control

Официальное название

Capsaicin in Digital Osteoarthritis Versus Control : a Randomized Study

Обзор

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)

Подробное описание

Visit 0 : Screening visit (D0 - 30 days): Screen for eligibility

Visit 1 :Inclusion visit (D0): Randomization and blinded patch application of capsaicin 8% or 0.04%

Visit 2: Follow-up visit 1 (D60 + 7 days): Assessment +/- Patch renewal. Patients with finger pain still greater than 4/10 may receive an open application of a capsaicin 8%

Visit 3:Follow-up visit 2 (D120 +/- 7 days): Final assessment.

For the duration of the study, the patient will record in a notebook: analgesics, anti-inflammatories, corticoids and daily hand pain VAS.

Blood samples will be taken at V1 and V2 for subsequent measurement of pro-inflammatory cytokines (IL6, IL8, TNFa) and markers of cartilage degradation, in order to build up a serum library.

Вмешательства

• Препарат Capsaicin 179 Mg Cutaneous Patch
  patch application for 30 minutes on the painful fingers.
• Препарат 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).

Первичные конечные точки

• Intensity of pain in the fingers [Срок оценки: Day 60]

Вторичные конечные точки (6)

• Functional disability [Срок оценки: Day 60]
• Functional index [Срок оценки: Day 60]
• Anxiety and depression [Срок оценки: Day 60]
• Painful symptoms of osteoarthritis [Срок оценки: Day 60]
• Treatment safety [Срок оценки: Day 60]
• Patient impression of change [Срок оценки: Day 60]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Франция · 4 центра

• CHU de Clermont-Ferrand — Clermont-Ferrand
• HCL Hôpital Edouard Herriot — Lyon
• AP-HP Hôpital Saint-Antoine — Paris
• CHU de Saint-Etienne — Saint-Etienne

Публикации

• Fan A, Lambert C, Sellam J, Chapurlat R, Marotte H, Pereira B, Thomas T, Tournadre A, Soubrier M, Mathieu S. CADOR (Capsaicin in neuropathic-like pain in digital osteoarthritis) study protocol: a multicentre randomised parallel-group trial. BMJ Open. 2025 Mar 6;15(3):e093409. doi: 10.1136/bmjopen-2024-093409. PMID 40050054

Идентификаторы

NCT: NCT06444919 · PHRC IR 2022 MATHIEU · 2024-511159-16-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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