Capsaicin in Digital Osteoarthritis Versus Control (CADOR)

Capsaicin in Digital Osteoarthritis Versus Control : a Randomized Study

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)

Study Overview

• Status: Recruiting
• Conditions: Neuropathic Pain; Osteoarthritis Hand
• Intervention / Treatment: Drug: Capsaicin 179 Mg Cutaneous Patch; Drug: Capsaicine low dose 0.04 %

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Lise Laclautre; Phone Number: 334.73.754.963; Email: promo_interne_drci@chu-clermontferrand.fr

Study Locations

• France
  • Clermont-Ferrand, France
    • Recruiting
    • CHU de Clermont-Ferrand
    • Contact: Lise LACLAUTRE
    • Principal Investigator: Sylvain MATHIEU
  • Lyon, France
    • Recruiting
    • HCL Hopital Edouard Herriot
    • Contact: Lise LACLAUTRE
    • Principal Investigator: Roland Chapurlat
  • Paris, France
    • Recruiting
    • AP-HP Hôpital Saint-Antoine
    • Contact: Lise LACLAUTRE
    • Principal Investigator: Jérémie SELLAM
  • Saint-Étienne, France
    • Recruiting
    • CHU de Saint-Etienne
    • Contact: Lise LACLAUTRE
    • Principal Investigator: Thierry Thomas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Capsaicin 8%; patch 179 mg, 30 min	Drug: Capsaicin 179 Mg Cutaneous Patch; patch application for 30 minutes on the painful fingers.; Other Names: QUTENZA
Sham Comparator: Capsaicin 0.04%; patch low dose, 30 min	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).; Other Names: control treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of pain in the fingers	measured on a visual analogic scale ranging from 0 to 100 mm	Day 60

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment safety	side effect rate	Day 60
Functional disability	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.	Day 60
Functional index	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.	Day 60
Anxiety and depression	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.	Day 60
Painful symptoms of osteoarthritis	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.	Day 60
Patient impression of change	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	Day 60

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Grünenthal GmbH
• Investigators: Principal Investigator: Sylvain MATHIEU, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Estimated): March 7, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: May 31, 2024
• First Submitted That Met QC Criteria: May 31, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Neuromuscular Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Peripheral Nervous System Diseases; Osteoarthritis; Neuralgia; Physiological Effects of Drugs; Peripheral Nervous System Agents; Dermatologic Agents; Sensory System Agents; Antipruritics; Capsaicin
• Other Study ID Numbers: PHRC IR 2022 MATHIEU; 2024-511159-16-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No