Analgesic Efficacy of Capsaicin 8% Patch (QUTENZA®) in Coccygodygnia (CAPSACOXp)

August 1, 2023 updated by: Nantes University Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • Patients who received topical Capsaicin 8% patch therapy for the treatment of their coccygodygnia between August 2016 and August 2022

Exclusion Criteria:

  • Patients who have already received 8% Capsaicin patch topical treatment in coccyx area.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Responder rate
Time Frame: 3 months after the inclusion visit.
Success defined by PGIC ≤ 2.
3 months after the inclusion visit.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Therapeutic response neuropathic predictive factors
Time Frame: 3 months after the inclusion visit
Identification of baseline neuropathic predictive factors (extracted from DN4 criteria) of Capsaïcine 8% efficacy at 3months (ie. PGIC ≤ 2)
3 months after the inclusion visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 15, 2023

Primary Completion (Estimated)

December 17, 2023

Study Completion (Estimated)

December 21, 2023

Study Registration Dates

First Submitted

March 6, 2023

First Submitted That Met QC Criteria

August 1, 2023

First Posted (Actual)

August 9, 2023

Study Record Updates

Last Update Posted (Actual)

August 9, 2023

Last Update Submitted That Met QC Criteria

August 1, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAPSACOXp_AL_06032023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Anonymized dataset. No sharing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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