Evolution of Different Sensitivity Levels in Patients With Chronic Neuropathic Pain in the Pelvi-perineal Region After Treatment With High-concentration Capsaicin Patches (CAPSASENS)
2026년 6월 15일 업데이트: Nantes University Hospital
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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
30
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Amélie LEVESQUE, MD
- 전화번호: +33240083912
- 이메일: amelie.levesque@chu-nantes.fr
연구 장소
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Nantes, 프랑스
- Nantes university hospital
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연락하다:
- Nantes University Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Pain sensitization parameter testing
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. |
Quantitative Sensory Testing and questionnaires
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Composite criterion
기간: Difference between Day 0 and Day 30
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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.
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Difference between Day 0 and Day 30
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (1)
기간: Between before and 30 days after patch application
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Difference in pressure pain thresholds in the treated area
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Between before and 30 days after patch application
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Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (2)
기간: Between before and 30 days after patch application
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Difference in mechanical stimulation pain thresholds
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Between before and 30 days after patch application
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Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (3)
기간: Between before and 30 days after patch application
|
Difference in cold pain thresholds in the treated area
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Between before and 30 days after patch application
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Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (4)
기간: Between before and 30 days after patch application
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Difference in heat pain thresholds in the treated area
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Between before and 30 days after patch application
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Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (5)
기간: Between before and 30 days after patch application
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Difference in pain receptive field area
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Between before and 30 days after patch application
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Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (1)
기간: Between before and 1 month after patch application.
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Difference in pressure pain thresholds in an area of the dermatome not directly treated by the patch:
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Between before and 1 month after patch application.
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Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (2)
기간: 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
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Between before and 1 month after patch application.
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Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (3)
기간: 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.
|
Between before and 1 month after patch application.
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Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (4)
기간: 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.
|
Between before and 1 month after patch application.
|
|
Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (5)
기간: Between before and 1 month after patch application.
|
Difference in the area under the curve of temporal summation measurements in the treated area
|
Between before and 1 month after patch application.
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Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (6)
기간: Between before and 1 month after patch application.
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Difference in the duration of pain persistence after the end of temporal summation (in seconds).
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Between before and 1 month after patch application.
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Measure the patient's therapeutic response to the treatment
기간: Day 30
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Patient Global Impression of Change (PGI-C).
The therapeutic response is defined as a patient who scores 1 to 3 on the PGI-C.
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Day 30
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Evaluate the predictive value of temporal summation with regard to the therapeutic response to the high-concentration capsaicin patch
기간: Between before and 1 month after patch application.
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Investigation of a relevant threshold for temporal summation to predict the therapeutic response.
Quantification of the positive predictive value.
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Between before and 1 month after patch application.
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Measure the correlation between Convergences PP scores, CSI, and semi-objective sensitization data
기간: Between before and 1 month after patch application
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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. |
Between before and 1 month after patch application
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 9월 1일
기본 완료 (추정된)
2028년 3월 1일
연구 완료 (추정된)
2028년 3월 1일
연구 등록 날짜
최초 제출
2026년 6월 15일
QC 기준을 충족하는 최초 제출
2026년 6월 15일
처음 게시됨 (실제)
2026년 6월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 15일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- RC25_0536
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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