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NCT Number: NCT07660510

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

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.

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Key information

Conditions

Neuropathic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Nociplastic Pain Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nantes University Hospital

Nantes, France

Location contact

Nantes University Hospital

CONTACT

About this study

Category 2 Study (Interventional Research with Minimal Risks and Constraints), monocentric, uncontrolled, non-randomized, open-label and prospective.

This study involves conducting tests and questionnaires before and 1 month after the application of a patch administered as part of standard clinical practice.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men or women ≥ 18 years old.
  • Patients suffering from chronic pelvi-perineal neuralgia (>3 months) with a DN4 score ≥4 at the inclusion visit, with or without symptoms of central sensitization, and with an indication for topical treatment with high-concentration capsaicin patch (PCHC).
  • Patients who have signed the informed consent form for the study at the inclusion visit.
  • Women must meet one of the following criteria at the time of inclusion:
  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Quantitative Sensory Testing and questionnaires

Other

Quantitative Sensory Testing and questionnaires

Primary outcomes

  1. Composite criterion

    Time frame: Difference between Day 0 and Day 30

    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.

Secondary outcomes

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

    Time frame: Between before and 30 days after patch application

    Difference in pressure pain thresholds in the treated area

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

    Time frame: Between before and 30 days after patch application

    Difference in mechanical stimulation pain thresholds

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

    Time frame: Between before and 30 days after patch application

    Difference in cold pain thresholds in the treated area

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

    Time frame: Between before and 30 days after patch application

    Difference in heat pain thresholds in the treated area

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

    Time frame: Between before and 30 days after patch application

    Difference in pain receptive field area

  6. Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (1)

    Time frame: Between before and 1 month after patch application.

    Difference in pressure pain thresholds in an area of the dermatome not directly treated by the patch:

    • Ipsilateral retro-malleolar groove (S2 root) for inferior cluneal nerve neuralgia treatment,
    • Posterior iliac crest relief, 7 cm from the midline (L1) for ilio-inguinal or ilio-hypogastric neuralgia treatment,
    • Perineal body (S4) for sacrococcygeal plexus neuralgia treatment.

  7. Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (2)

    Time frame: Between before and 1 month after patch application.

    Difference in mechanical stimulation pain thresholds in an area of the dermatome not directly treated by the patch

  8. Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (3)

    Time frame: Between before and 1 month after patch application.

    Difference in cold pain thresholds in an area of the dermatome not directly treated by the patch.

  9. Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (4)

    Time frame: Between before and 1 month after patch application.

    Difference in heat pain thresholds in an area of the dermatome not directly treated by the patch.

  10. Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (5)

    Time frame: Between before and 1 month after patch application.

    Difference in the area under the curve of temporal summation measurements in the treated area

  11. Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (6)

    Time frame: Between before and 1 month after patch application.

    Difference in the duration of pain persistence after the end of temporal summation (in seconds).

  12. Measure the patient's therapeutic response to the treatment

    Time frame: Day 30

    Patient Global Impression of Change (PGI-C). The therapeutic response is defined as a patient who scores 1 to 3 on the PGI-C.

  13. Evaluate the predictive value of temporal summation with regard to the therapeutic response to the high-concentration capsaicin patch

    Time frame: Between before and 1 month after patch application.

    Investigation of a relevant threshold for temporal summation to predict the therapeutic response. Quantification of the positive predictive value.

  14. Measure the correlation between Convergences PP scores, CSI, and semi-objective sensitization data

    Time frame: Between before and 1 month after patch application

    Measure the correlation between Convergences PP scores, CSI, and semi-objective sensitization data. The Convergences PP score is a clinical questionnaire used to diagnose sensitization in the pelvic region. A score is considered positive from 5/10 (sensitivity = 95%, specificity = 87%).

    The Central Sensitization Inventory (CSI) is a self-administered questionnaire used to diagnose central sensitization. A score is considered positive from 40/100.

    Correlations between the Convergences PP score, CSI, and semi-objective sensitization data (pain thresholds and temporal summation) will be measured using Spearman's correlation coefficient to explore the relationships between these variables.

Study contacts

Contact information is provided by the study sponsor or research team.

Amélie LEVESQUE, MD

CONTACT

[email protected]

+33240083912

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: CAPSASENS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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