RecruitingPhase 4NCT06444919

Capsaicin in Digital Osteoarthritis Versus Control

Capsaicin in Digital Osteoarthritis Versus Control : a Randomized Study


Sponsor

University Hospital, Clermont-Ferrand

Enrollment

120 participants

Start Date

Mar 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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)


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria11

  • 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;

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Interventions

DRUGCapsaicin 179 Mg Cutaneous Patch

patch application for 30 minutes on the painful fingers.

DRUGCapsaicine 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).


Locations(4)

CHU de Clermont-Ferrand

Clermont-Ferrand, France

HCL Hôpital Edouard Herriot

Lyon, France

AP-HP Hôpital Saint-Antoine

Paris, France

CHU de Saint-Etienne

Saint-Etienne, France

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NCT06444919


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