Evolution of Different Sensitivity Levels in Patients With Chronic Neuropathic Pain in the Pelvi-perineal Region After Treatment With High-concentration Capsaicin Patches (CAPSASENS)
2026年6月15日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
30
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Amélie LEVESQUE, MD
- 電話番号：+33240083912
- メール：amelie.levesque@chu-nantes.fr
研究場所
-
-
-
Nantes、フランス
- Nantes university hospital
-
コンタクト：
- Nantes University Hospital
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Composite criterion
時間枠：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.
|
Difference between Day 0 and Day 30
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (1)
時間枠：Between before and 30 days after patch application
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Difference in pressure pain thresholds in the treated area
|
Between before and 30 days after patch application
|
|
Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (2)
時間枠：Between before and 30 days after patch application
|
Difference in mechanical stimulation pain thresholds
|
Between before and 30 days after patch application
|
|
Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (3)
時間枠：Between before and 30 days after patch application
|
Difference in cold pain thresholds in the treated area
|
Between before and 30 days after patch application
|
|
Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (4)
時間枠：Between before and 30 days after patch application
|
Difference in heat pain thresholds in the treated area
|
Between before and 30 days after patch application
|
|
Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (5)
時間枠：Between before and 30 days after patch application
|
Difference in pain receptive field area
|
Between before and 30 days after patch application
|
|
Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (1)
時間枠：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:
|
Between before and 1 month after patch application.
|
|
Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (2)
時間枠：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
|
Between before and 1 month after patch application.
|
|
Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (3)
時間枠：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.
|
|
Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (4)
時間枠：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)
時間枠：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.
|
|
Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (6)
時間枠：Between before and 1 month after patch application.
|
Difference in the duration of pain persistence after the end of temporal summation (in seconds).
|
Between before and 1 month after patch application.
|
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Measure the patient's therapeutic response to the treatment
時間枠：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.
|
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
時間枠：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.
|
Between before and 1 month after patch application.
|
|
Measure the correlation between Convergences PP scores, CSI, and semi-objective sensitization data
時間枠：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. |
Between before and 1 month after patch application
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2028年3月1日
研究の完了 (推定)
2028年3月1日
試験登録日
最初に提出
2026年6月15日
QC基準を満たした最初の提出物
2026年6月15日
最初の投稿 (実際)
2026年6月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月22日
QC基準を満たした最後の更新が送信されました
2026年6月15日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- RC25_0536
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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