Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06444919

Capsaicin in Digital Osteoarthritis Versus Control

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)

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU de Clermont-Ferrand, Clermont-Ferrand, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Capsaicin 179 Mg Cutaneous Patch

Drug

patch application for 30 minutes on the painful fingers.

Other names: QUTENZA

Capsaicine low dose 0.04 %

Drug

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).

Other names: control treatment

Primary outcomes

  1. Intensity of pain in the fingers

    Time frame: Day 60

    measured on a visual analogic scale ranging from 0 to 100 mm

Secondary outcomes

  1. Functional disability

    Time frame: Day 60

    Cochin Hand Functional Disability Scale score, Each question is rated from 0 (no difficulty) to 5 (impossible). Total score for 18 questions: 0 - 90. The higher the score, the more impaired the physical function.

  2. Functional index

    Time frame: Day 60

    Modified Functional Index for Hand OsteoArthritis score (FIHOA), Each question is rated from 0 (no difficulty) to 3 (impossible). Total score for the 10 questions: 0 - 30. The higher the score, the greater the functional disability.

  3. Anxiety and depression

    Time frame: Day 60

    Hospital Anxiety and Depression Scale score (HADs), Each question is scored from 0 to 3. Total score for the 7 anxiety or depression questions: 0-21. The higher the score, the more anxious or depressed the patient.

  4. Painful symptoms of osteoarthritis

    Time frame: Day 60

    Osteoarthritis Symptom Inventory Scale score (OASIS9). Localized pain component = 4 questions rated from 0 (no sensation) to 10 (extreme sensation) score = 0-40.

    Neuropathic pain component = 2 questions rated from 0 to 10 score = 0-20. Deep pain component = 3 questions rated from 0 to 10 score = 0-30. Total OASIS score: 0-90. A high score indicates intense pain.

  5. Treatment safety

    Time frame: Day 60

    side effect rate

  6. Patient impression of change

    Time frame: Day 60

    Patient Global Impression of Change " (PGIC) score. The patient evaluates the degree of improvement of his pain

    • - Strongly improved
    • - Moderately improved
    • - Slightly improved
    • - No change
    • - Slightly worsened
    • - Moderately worsened
    • - Strongly worsened

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Laclautre

CONTACT

[email protected]

334.73.754.963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Grünenthal GmbH

Registry information

Official study title

Capsaicin in Digital Osteoarthritis Versus Control : a Randomized Study

Acronym: CADOR

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 6, 2024
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.