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Capsaicin in Digital Osteoarthritis Versus Control

ConditionsOsteoarthritis HandNeuropathic Pain
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Clermont-Ferrand

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Capsaicin 179 Mg Cutaneous Patch

    Drug

    patch application for 30 minutes on the painful fingers.

  • 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).

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Capsaicin 8%Experimental treatment 1 intervention
Group B: Capsaicin 0.04%Sham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Intensity of pain in the fingers

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

Time frame
Day 60

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Clermont-Ferrand

Lead sponsor

Grünenthal GmbH

Collaborator

Source ClinicalTrials.gov
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