Not yet recruiting NCT07660510
Evolution of Different Sensitivity Levels in Patients With Chronic Neuropathic Pain in the Pelvi-perineal Region After Treatment With High-concentration Capsaicin Patches
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Quantitative Sensory Testing and questionnaires.
- Who it may be relevant to
- Registry conditions: Neuropathic Pain, Nociplastic Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Other Quantitative Sensory Testing and questionnaires
Quantitative Sensory Testing and questionnaires
Primary outcome measures
- Composite criterion [Time frame: Difference between Day 0 and Day 30]
Secondary outcome measures (12)
- Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (1) [Time frame: Between before and 30 days after patch application]
- Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (2) [Time frame: Between before and 30 days after patch application]
- Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (3) [Time frame: Between before and 30 days after patch application]
- Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (4) [Time frame: Between before and 30 days after patch application]
- Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (5) [Time frame: Between before and 30 days after patch application]
- Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (1) [Time frame: Between before and 1 month after patch application.]
- Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (2) [Time frame: Between before and 1 month after patch application.]
- Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (3) [Time frame: Between before and 1 month after patch application.]
- Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (4) [Time frame: Between before and 1 month after patch application.]
- Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (5) [Time frame: Between before and 1 month after patch application.]
- Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (6) [Time frame: Between before and 1 month after patch application.]
- Measure the patient's therapeutic response to the treatment [Time frame: Day 30]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Nantes University Hospital — Nantes
Identifiers
NCT: NCT07660510 · RC25_0536