Evaluating the effectiveness of capsaicin patches for chronic coccyx pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: amelie.levesque@chu-nantes.fr
• Phone: +33240083912

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.