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

NCT05983263 | Recruiting

• 1 other identifier: CAPSACOXp_AL_06032023
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Coccyx Disorder

Keywords

Chronic Coccygodynia; Neuropathic pain; Capsaicine 8%

Outcome Measures

Primary Outcomes (1)

• Responder rate

  Success defined by PGIC ≤ 2.

  3 months after the inclusion visit.

Secondary Outcomes (1)

• Therapeutic response neuropathic predictive factors

  3 months after the inclusion visit

Interventions

Capsaicin DRUG

Capsaicin 8% patch (QUTENZA) apposed in coccygeal area

Also known as: Capsaicin 8% patch

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU de Nantes

Nantes, 44093, France

RECRUITING

MeSH Terms

Conditions

Neuralgia

Interventions

Capsaicin; Transdermal Patch

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Equipment and Supplies

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: August 9, 2023
• Study Start: November 8, 2023
• Primary Completion (Estimated): March 8, 2027
• Study Completion (Estimated): June 8, 2027
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)