Coccyx DisorderCAPSACOXpNCT05983263
Analgesic Efficacy of Capsaicin 8% Patch (QUTENZA®) in Coccygodygnia
An observational study of Coccyx Disorder, run by Nantes University Hospital at 1 site in France.
Trial summary
A retrospective study over a period of 6 years to explore analgesic efficacy of 8% Capsaicin patch (QUTENZA®) in coccygodynic patients, as well as neuropathic predictive factors of therapeutic response. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coccyx Disorder
- What is being tested?
- Capsaicin
- How many people
- 106 participants
- Where
- 1 siteFrance
- Study dates
- 8 Nov 2023to 8 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Medical files of 106 patients hospitalized between 2016 and 2022 for persisting coccygodynia (>3months) and at least one neuropathic symptom in pain expression, and who received capsaicin 8% patch (QUTENZA®) topical treatment.
Who may be able to join
- Patients who received topical Capsaicin 8% patch therapy for the treatment of their coccygodygnia between August 2016 and August 2022
Who cannot join
- Patients who have already received 8% Capsaicin patch topical treatment in coccyx area.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nantes
Nantes, 44093
Amélie SENEAU-LEVESQUE, 0240083912, amelie.levesque@chu-nantes.fr
About this study
Official title: Neuropathic Determining Factors and Analgesic Efficacy of Capsaicin 8% (QUTENZA®) Patches in Refractory Coccygodygnia
A retrospective study over a period of 6 years to explore analgesic efficacy of 8% Capsaicin patch (QUTENZA®) in coccygodynic patients, as well as neuropathic predictive factors of therapeutic response.
Read the detailed description
Coccygodynia corresponds to a localized pain in the coccyx region, aggravated or triggered by sitting and/or by getting up from a seat. Even if there is no epidemiology of this pain in France, coccygodynia represents a frequent recourse to specialized consultations (Rheumatology or Algology). Currently in France, there is no recommendation on the management of chronic disabling coccygodynia. Treatments are proposed in accordance with known/presumed underlying pathophysiology. Anti-inflammatory drugs and manual therapy (pressure relief cushions) are thus always offered as first-line treatments. But despite their common use/prescription, their efficacy is variable, with low level of evidence. More over, upstream of invasive coccygectomy, therapeutic arsenal is largely deficient, inviting to explore new approaches. Considering frequent neuropathic expression in coccygodynic pain pattern (tingling, itching, pain cold sensation…), capsaïcine 8% patch (QUTENZA®) are often performed. And in the same way, no/few researches tried to measure real-life analgesic pain efficacy of QUTENZA® strategy. Observational retrospective study (non-interventional anonymized data) CAPSACOXp aims to assess analgesic efficacy of Capsaicin 8% patch (QUTENZA®) and explore possible neuropathic determinants of therapeutic response in coccygodynia.
- Conditions
- Coccyx Disorder
- Being tested
- Capsaicin
- Keywords
- Chronic Coccygodynia, Neuropathic pain, Capsaicine 8%
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapsaicinDrug
Also called Capsaicin 8% patch
Capsaicin 8% patch (QUTENZA) apposed in coccygeal area
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder rate
Success defined by PGIC ≤ 2.
Measured: 3 months after the inclusion visit.
Secondary outcomes (1)
Therapeutic response neuropathic predictive factors
Identification of baseline neuropathic predictive factors (extracted from DN4 criteria) of Capsaïcine 8% efficacy at 3months (ie. PGIC ≤ 2)
Measured: 3 months after the inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start8 Nov 2023
- Primary completion8 Mar 2027 (estimated)
- Study completion8 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coccyx DisorderStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983263
- Sponsor's protocol ID
- CAPSACOXp_AL_06032023
- Acronym
- CAPSACOXp
- Status last verified
- Jun 2026
- First submitted
- 6 Mar 2023
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymized dataset. No sharing.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropathic Determining Factors and Analgesic Efficacy of Capsaicin 8% (QUTENZA®) Patches in Refractory Coccygodygnia
- ClinicalTrials.gov ID
- NCT05983263
- Acronym / sponsor ID
- CAPSACOXp / CAPSACOXp_AL_06032023
- Conditions
- Coccyx Disorder
- Keywords
- Chronic Coccygodynia, Neuropathic pain, Capsaicine 8%
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 8 Mar 2027 (estimated)
- Study completion
- 8 Jun 2027 (estimated)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A retrospective study over a period of 6 years to explore analgesic efficacy of 8% Capsaicin patch (QUTENZA®) in coccygodynic patients, as well as neuropathic predictive factors of therapeutic response.
Detailed description
Coccygodynia corresponds to a localized pain in the coccyx region, aggravated or triggered by sitting and/or by getting up from a seat. Even if there is no epidemiology of this pain in France, coccygodynia represents a frequent recourse to specialized consultations (Rheumatology or Algology). Currently in France, there is no recommendation on the management of chronic disabling coccygodynia. Treatments are proposed in accordance with known/presumed underlying pathophysiology. Anti-inflammatory drugs and manual therapy (pressure relief cushions) are thus always offered as first-line treatments. But despite their common use/prescription, their efficacy is variable, with low level of evidence. More over, upstream of invasive coccygectomy, therapeutic arsenal is largely deficient, inviting to explore new approaches. Considering frequent neuropathic expression in coccygodynic pain pattern (tingling, itching, pain cold sensation…), capsaïcine 8% patch (QUTENZA®) are often performed. And in the same way, no/few researches tried to measure real-life analgesic pain efficacy of QUTENZA® strategy. Observational retrospective study (non-interventional anonymized data) CAPSACOXp aims to assess analgesic efficacy of Capsaicin 8% patch (QUTENZA®) and explore possible neuropathic determinants of therapeutic response in coccygodynia.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Medical files of 106 patients hospitalized between 2016 and 2022 for persisting coccygodynia (>3months) and at least one neuropathic symptom in pain expression, and who received capsaicin 8% patch (QUTENZA®) topical treatment.
Key inclusion criteria (1 listed)
- Patients who received topical Capsaicin 8% patch therapy for the treatment of their coccygodygnia between August 2016 and August 2022
Key exclusion criteria (1 listed)
- Patients who have already received 8% Capsaicin patch topical treatment in coccyx area.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapsaicinAlso: Capsaicin 8% patchCapsaicin 8% patch (QUTENZA) apposed in coccygeal area | Drug | – |
Primary outcome
Responder rate
Time frame: 3 months after the inclusion visit.
Success defined by PGIC ≤ 2.
1 secondary outcome
Therapeutic response neuropathic predictive factors
Time frame: 3 months after the inclusion visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No. Anonymized dataset. No sharing.
Related trials for Coccyx Disorder
RecruitingPhase 3
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coccyx Disorder, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder rate (time frame: 3 months after the inclusion visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.