Capsaicin in Digital Osteoarthritis Versus Control

Phase 4RecruitingNCT06444919

University Hospital, Clermont-Ferrand120 enrolled

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)

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Osteoarthritis Hand Neuropathic Pain

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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;

Locations (4)

CHU de Clermont-Ferrand

Clermont-Ferrand, France

RECRUITING

HCL Hôpital Edouard Herriot

Lyon, France

RECRUITING

AP-HP Hôpital Saint-Antoine

Paris, France

RECRUITING

CHU de Saint-Etienne

Saint-Etienne, France

RECRUITING

Outcomes

Primary Outcomes

Intensity of pain in the fingers

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

Time frame: Day 60

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Day 60

Treatment safety

side effect rate

Time frame: Day 60

Patient impression of change

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

Time frame: Day 60

Capsaicin in Digital Osteoarthritis Versus Control

Overview

Conditions

Interventions

Eligibility

Locations (4)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts