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Recruiting Phase 3 NCT06023706

Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia.

Trial Parameters

Condition Coccyx Disorder
Sponsor Nantes University Hospital
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 188
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-11-08
Completion 2027-01-08
Interventions
Capsaicin 179 Mg Cutaneous PatchCapsaicin low concentration patch (capsaicin 0,04%, 3,2 mg/cm2)

Brief Summary

The primary objective is to demonstrate the analgesic effect at day 60 of 8% capsaicin patch (Qutenza) for the treatment of patients with coccygodyinia.

Eligibility Criteria

Inclusion Criteria: * \>18 years old at the pre-inclusion visit * Presenting with chronic coccygodynia: pain in the coccygeal region, increased by sitting and or when rising from a sitting position and pain over the last ten days of intensity greater than or equal to four on the eleven-point numerical scale (from zero to ten) and having been present for more than 3 months. * Failure of previous treatments: NSAIDs, pressure-relieving cushions and/or infiltration or having a contraindication to these treatments, or not wishing to receive these treatments * Have never been treated with an 8% capsaicin patch for this indication * With at least one clinical sign suggestive of neuropathic pain (burning, painful cold, numbness, tingling, electric discharge, allodynia of the gluteal groove, allodynia to pressure on the coccyx) * Proficiency in reading and writing the French language * Be affiliated to the social security system * Have signed an informed consent form * Women must meet one of th

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