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Nursing study, prospective, randomized, two-center open-label.
Patients will be randomized into two groups during their first laying Qutenza®:
The objective of the study is to evaluate the effectiveness of the application of cold to the reduction of pain (burning) after one hour of patch installation high concentration capsaicin (Qutenza®) in patients localized neuropathic pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Qutenza® without refrigerated cushion | No Intervention | Qutenza® without refrigerated cushion | |
| Qutenza® with refrigerated cushion | Experimental | Qutenza® with refrigerated cushion |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| refrigerated cushion | Other | refrigerated cushion |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Pain Scale (Burning Pain) | Burning pain will be estimated by the patient using a non-graduated 10 cm line, presented horizontally to the patient with the extreme position of the vertical border on the left (0mm) representing the absence of perceived pain and the extreme position on the right (10 cm), the perception of the maximum pain that the patient can imagine. The information obtained is measured and translated into a score between 0 and 10. The patient will be asked: "How would you rate the intensity of pain caused by Qutenza patch application? | after 1 hour of installation of Qutenza patch |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHLVO de Challans | Challans | 85300 | France | |||
| CHD Vendée de la Roche sur Yon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39532578 | Result | Tailliez N, Planche L, Dorion A, Kacki N, Dimet J, Pluchon YM. Effect of Cooling Capsaicin Application Site on Reducing Burning Sensation in Neuropathic Pain Patients: A Randomized Controlled Trial. Pain Manag Nurs. 2025 Apr;26(2):e159-e164. doi: 10.1016/j.pmn.2024.09.001. Epub 2024 Nov 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Qutenza® without refrigerated cushion | Qutenza® without refrigerated cushion |
| FG001 | Qutenza® with refrigerated cushion | Qutenza® with refrigerated cushion refrigerated cushion: refrigerated cushion |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 15, 2020 |
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| La Roche-sur-Yon |
| 85925 |
| France |
| Clinique Brétéché | Nantes | 44000 | France |
| COMPLETED |
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| NOT COMPLETED |
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All analyses were performed according to the intention-to-treat principle by including all randomized patients to whom the Qutenza® patch was applied.
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| ID | Title | Description |
|---|---|---|
| BG000 | Qutenza® Without Refrigerated Cushion | Qutenza® without refrigerated cushion |
| BG001 | Qutenza® With Refrigerated Cushion | Qutenza® with refrigerated cushion refrigerated cushion: refrigerated cushion |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Visual Analogue Pain Scale (Burning Pain) | Burning pain will be estimated by the patient using a non-graduated 10 cm line, presented horizontally to the patient with the extreme position of the vertical border on the left (0mm) representing the absence of perceived pain and the extreme position on the right (10 cm), the perception of the maximum pain that the patient can imagine. The information obtained is measured and translated into a score between 0 and 10. The patient will be asked: "How would you rate the intensity of pain caused by Qutenza patch application? | Intent to treat Population (all participants who received a Qutenza patch) | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | after 1 hour of installation of Qutenza patch |
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Death, serious adverse events and other (non serious adverse events) were not assessed for the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Qutenza® without refrigerated cushion | Qutenza® without refrigerated cushion | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Qutenza® with refrigerated cushion | Qutenza® with refrigerated cushion refrigerated cushion: refrigerated cushion | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Yves-Marie PLUCHON | Centre Hospitalier Départemental Vendée | 251446248 | +33 | yves-marie.pluchon@chd-vendee.fr |
| Mar 7, 2023 |
| Prot_SAP_000.pdf |
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