Evaluating the effectiveness of capsaicin patches for chronic coccyx pain

Phase 3 Confirmatory, Randomised 1:1 Double-blind, Placebo-controlled Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia.

This study is testing if an 8% capsaicin patch can help people with chronic tailbone pain feel better compared to a lower concentration patch.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 188 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nantes University Hospital (Academic / other)
• Locations: 6 sites (Brest and 5 other locations)
• Trial ID: NCT06023706 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the analgesic efficacy of an 8% capsaicin patch in patients suffering from chronic coccygodynia. It is a multicenter, randomized, controlled, double-blind study conducted in France, where participants will be monitored for five months following a one-hour treatment with the patch. The primary outcome is to evaluate pain relief at day 60 using a numerical pain scale. Patients will also receive a low concentration capsaicin patch as a comparison.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with chronic coccygodynia who have not responded to previous treatments and exhibit signs of neuropathic pain.

Not a fit: Patients who have previously been treated with an 8% capsaicin patch for coccygodynia or those who do not meet the pain intensity criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide significant pain relief for patients suffering from chronic coccygodynia.

How similar studies have performed: Previous studies have shown promise in using capsaicin patches for neuropathic pain, suggesting potential success for this approach in treating coccygodynia.

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 the following criteria at the time of inclusion:
* be using adequate contraceptive measures, and have a negative pregnancy test (specify if urine or blood test) prior to receiving the first dose of trial medication;
* or be post-menopausal (aged over 50 with amenorrhoea for at least 12 months after stopping all exogenous hormonal treatments)
* or (if under 50) have been in amenorrhoea for at least 12 months after stopping all exogenous hormone treatments and with luteinising hormone (LH) and follicle stimulating hormone (FSH) levels corresponding to post-menopausal levels.
* or have undergone irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy (this operation must be documented).

Exclusion Criteria:

* Coccygodynia accompanied by a dermatological lesion in the intergluteal cleft (psoriasis, pilodinial cyste, wound)
* Patients with other major pain disorders likely to interfere with pain assessment
* Hypersensitivity to capsaicin or to one of the excipients
* Adults under legal protection (guardianship, curatorship, legal protection)
* Pregnant or breast-feeding women
* Patients who have undergone total coccygectomy

Where this trial is running

Brest and 5 other locations

• Brest University Hospital — Brest, France (Recruiting)
• Vendée Departmental Hospital — La Roche-sur-Yon, France (Recruiting)
• Confluent Private Hospital Centre — Nantes, France (Recruiting)
• Nantes University Hospital — Nantes, France (Recruiting)
• GH Paris saint Joseph — Paris, France (Recruiting)
• Rouen University Hospital — Rouen, France (Recruiting)

Study contacts

• Study coordinator: Amélie LEVESQUE, MD

Conditions Coccyx Disorder; Neuropathic Pain; Coccygodynia