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

Not yet recruiting

• Conditions: Coccyx Disorder

• Registration Number: NCT05983263
• Lead Sponsor: Nantes University Hospital

Brief 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.

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 Timeline

• Study First Submitted: 2023-03-06
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-01
• Last Update Submitted: 2023-08-01
• Study First Posted: 2023-08-09
• Last Update Posted: 2023-08-09
• Study Start: 2023-08-15
• Primary Completion: 2023-12-17
• Study Completion: 2023-12-21

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 106

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Responder rate	3 months after the inclusion visit.	Success defined by PGIC ≤ 2.

Secondary Outcome Measures

Name	Time	Method
Therapeutic response neuropathic predictive factors	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)