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Recruiting NCT06444919

Capsaicin in Digital Osteoarthritis Versus Control

Phase IV Interventional Osteoarthritis Hand Neuropathic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Capsaicin 179 Mg Cutaneous Patch, Capsaicine low dose 0.04 %.
Who it may be relevant to
Registry conditions: Osteoarthritis Hand, Neuropathic Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Capsaicin in Digital Osteoarthritis Versus Control : a Randomized Study

Overview

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)

Detailed description

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.

Interventions

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

Primary outcome measures

  • Intensity of pain in the fingers [Time frame: Day 60]
Secondary outcome measures (6)
  • Functional disability [Time frame: Day 60]
  • Functional index [Time frame: Day 60]
  • Anxiety and depression [Time frame: Day 60]
  • Painful symptoms of osteoarthritis [Time frame: Day 60]
  • Treatment safety [Time frame: Day 60]
  • Patient impression of change [Time frame: Day 60]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

France · 4 centers
  • CHU de Clermont-Ferrand — Clermont-Ferrand
  • HCL Hôpital Edouard Herriot — Lyon
  • AP-HP Hôpital Saint-Antoine — Paris
  • CHU de Saint-Etienne — Saint-Etienne

Publications

  • 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

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗