Evolution of Different Sensitivity Levels in Patients With Chronic Neuropathic Pain in the Pelvi-perineal Region After Treatment With High-concentration Capsaicin Patches

NCT07660510 | Not Yet Recruiting

• 1 other identifier: RC25_0536
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study will be to demonstrate a change in pain sensitization parameters before and after the application of the high-concentration capsaicin patch.

Conditions

Neuropathic Pain; Nociplastic Pain

Keywords

Sensitization; 8% capsaicin patch; Quantitative Sensory Testing; Temporal Summation

Outcome Measures

Primary Outcomes (1)

• Composite criterion

  Composite criterion constructed from a Principal Component Analysis including the differences between Day 0 (before patch application) and Day 30 in pain perception thresholds (to cold, heat, pressure, and mechanical stimulation) in both the area treated with the high-concentration capsaicin patch and the corresponding dermatome, as well as the change in the pain receptive field area in the treated zone and the area under the curve of temporal summation measurements.

  Difference between Day 0 and Day 30

Secondary Outcomes (14)

• Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (1)

  Between before and 30 days after patch application

• Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (2)

  Between before and 30 days after patch application

• Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (3)

  Between before and 30 days after patch application

• Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (4)

  Between before and 30 days after patch application

• Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (5)

  Between before and 30 days after patch application

Study Arms (1)

Pain sensitization parameter testing

EXPERIMENTAL

Pre-inclusion visit (routine care consultation): Verification of inclusion and exclusion criteria. Inclusion visit (Day 0): Consent signing, questionnaires (ConvergencePP Score/Central Sensitization Inventory, DN4), and a series of tests, followed by the application of the high-concentration capsaicin patch (PCHC) (performed during routine care). Day 30 visit (±7 days): Questionnaires (same as V1 + PGI-c) and a series of tests.

Other: Quantitative Sensory Testing and questionnaires

Interventions

Quantitative Sensory Testing and questionnaires OTHER

Quantitative Sensory Testing and questionnaires

Pain sensitization parameter testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women ≥ 18 years old.
• Use adequate contraceptive measures;
• or Be postmenopausal (aged over 50 years with amenorrhea for at least 12 months after discontinuation of all exogenous hormonal treatments);
• or (If aged under 50 years) have been amenorrheic for at least 12 months after discontinuation of exogenous hormonal treatments, with luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels consistent with postmenopausal levels;
• or Have undergone irreversible surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), with documentation of the procedure.

You may not qualify if:

• Patients under guardianship, curatorship, or legal protection.
• Pregnant or breastfeeding women.
• Patients with contraindications to the use of the high-concentration capsaicin patch (PCHC): application on damaged skin, hypersensitivity to any of its components.
• Patients simultaneously starting a treatment that may influence central sensitization (e.g., antidepressants, antiepileptics, psychotherapy, physical activity, transcutaneous electrical nerve stimulation).
• Patients not affiliated with the French Social Security system.
• Patients with insufficient cooperation and/or understanding to strictly comply with the protocol requirements.
• Patients who have taken analgesics within the 12 hours prior to measurements.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, France

Location

MeSH Terms

Conditions

Neuralgia; Nociplastic Pain

Interventions

Surveys and Questionnaires

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)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Amélie LEVESQUE, MD

CONTACT

+33240083912; amelie.levesque@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 22, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: June 22, 2026

Record last verified: 2026-06

Locations

FR (1)