Pepper patch could ease tailbone pain without pills
NCT ID NCT06023706
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a high-dose capsaicin patch (made from chili pepper extract) can reduce chronic tailbone pain (coccygodynia) better than a low-dose patch. About 188 adults with pain lasting over 3 months will receive either the 8% patch or a control patch applied once for one hour. The main goal is to see if more people report improvement after 60 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- capsaicin 8% patch (Qutenza)
- What this could lead to
- If it works, this could offer a new, non-drug option to reduce chronic tailbone pain, making sitting and daily activities more comfortable.
- What could go wrong
- This is a Phase 3 trial, but the effect may be modest or no better than a low-dose patch. Skin irritation or burning at the patch site is a known side effect.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 188 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2023
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Brest University Hospital
RECRUITINGBrest, France
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Confluent Private Hospital Centre
RECRUITINGNantes, France
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GH Paris saint Joseph
RECRUITINGParis, France
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Nantes University Hospital
RECRUITINGNantes, France
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Rouen University Hospital
RECRUITINGRouen, France
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Vendée Departmental Hospital
RECRUITINGLa Roche-sur-Yon, France
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Other studies related to the condition(s) this trial covers.
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