Capsaicin in Digital Osteoarthritis Versus Control

Phase 4

Recruiting

• Conditions: Osteoarthritis Hand; Neuropathic Pain
• Interventions: Drug: Capsaicine low dose 0.04 %; Drug: Capsaicin 179 Mg Cutaneous Patch

• Registration Number: NCT06444919
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief 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)

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 Timeline

• Study First Submitted: 2024-05-31
• Study First Submitted QC: 2024-05-31
• Study First Posted: 2024-06-06
• Status Verified: 2025-02
• Study Start: 2025-03-07
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-13
• Primary Completion: 2028-01-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Capsaicin 0.04%	Capsaicine low dose 0.04 %	patch low dose, 30 min
Capsaicin 8%	Capsaicin 179 Mg Cutaneous Patch	patch 179 mg, 30 min

Primary Outcome Measures

Name	Time	Method
Intensity of pain in the fingers	Day 60	measured on a visual analogic scale ranging from 0 to 100 mm

Secondary Outcome Measures

Name	Time	Method
Anxiety and depression	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.
Functional index	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.
Patient impression of change	Day 60	Patient Global Impression of Change " (PGIC) score. The patient evaluates the degree of improvement of his pain; 1. - Strongly improved; 2. - Moderately improved; 3. - Slightly improved; 4. - No change; 5. - Slightly worsened; 6. - Moderately worsened; 7. - Strongly worsened
Functional disability	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.
Painful symptoms of osteoarthritis	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.
Treatment safety	Day 60	side effect rate

Trial Locations

Locations (4)

HCL Hôpital Edouard Herriot; 🇫🇷 Lyon, France

AP-HP Hôpital Saint-Antoine; 🇫🇷 Paris, France

CHU de Saint-Etienne; 🇫🇷 Saint-Étienne, France

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France