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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quantitative Sensory Testing and questionnaires | Other | Quantitative Sensory Testing and questionnaires |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (1) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amélie LEVESQUE, MD | Contact | +33240083912 | amelie.levesque@chu-nantes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nantes University Hospital | Nantes | France |
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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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | Difference in the duration of pain persistence after the end of temporal summation (in seconds). | Between before and 1 month after patch application. |
| Measure the patient's therapeutic response to the treatment | 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 |
| Evaluate the predictive value of temporal summation with regard to the therapeutic response to the high-concentration capsaicin patch | 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 | 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 |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D000098653 | Nociplastic Pain |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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