Back to resultsDoes the Application of Cold Decreases the Pain Associated in the Pose of a Patch of Capsaicine at High Concentration on the Carrier Patients of Localized Neuropathic Pains ? - DIDOCAP (DIDOCAP)
Primary Purpose
Localized Neuropathic Pain
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
refrigerated cushion
Sponsored by
About this trial
This is an interventional other trial for Localized Neuropathic Pain
Eligibility Criteria
Inclusion Criteria:
- Major
- Do not opposing the participation in the study
- Monitoring in the case of localized neuropathic pain
- Diagnostic with neuropathic pain score ≥ 4
- Neuropathic pain conventional treatment failure of first-line
- Front advantage of laying a first patch Qutenza®
- With ability to understand the proposed study
Exclusion Criteria:
- Patch Installation on the feet, face, mucous membranes
- Eutectic mixture of local anesthetics (EMLA) Pose premedication
- Having Already received prior to the installation of a patch of Qutenza®
- Allergy to components Qutenza®
- Known and poorly stabilized hypertension
- Known cryoglobulinaemia
- Pregnant or lactating women
- Patient enjoying a measure of legal protection (guardianship, guardianship ...)
- Private Patient freedom
- No affiliation to a social security scheme.
- Refusal to participate in the study
Sites / Locations
- CHLVO de Challans
- CHD Vendée de la Roche sur Yon
- Clinique Brétéché
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Qutenza® without refrigerated cushion
Qutenza® with refrigerated cushion
Arm Description
Qutenza® without refrigerated cushion
Qutenza® with refrigerated cushion
Outcomes
Primary Outcome Measures
visual analogue pain scale (burning pain)
visual analogue pain scale (burning pain)
Secondary Outcome Measures
Full Information
NCT ID
NCT02869867
First Posted
August 12, 2016
Last Updated
January 12, 2021
Sponsor
Centre Hospitalier Departemental Vendee
1. Study Identification
Unique Protocol Identification Number
NCT02869867
Brief Title
Does the Application of Cold Decreases the Pain Associated in the Pose of a Patch of Capsaicine at High Concentration on the Carrier Patients of Localized Neuropathic Pains ? - DIDOCAP
Acronym
DIDOCAP
Official Title
Does the Application of Cold Decreases the Pain Associated in the Pose of a Patch of Capsaicine at High Concentration on the Carrier Patients of Localized Neuropathic Pains ? - DIDOCAP
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 2, 2017 (Actual)
Primary Completion Date
December 4, 2020 (Actual)
Study Completion Date
December 4, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Departemental Vendee
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Nursing study, prospective, randomized, two-center open-label.
Patients will be randomized into two groups during their first laying Qutenza®:
Patients receiving the laying of Qutenza® without refrigerated cushion
Patients receiving the laying of Qutenza® associated with a refrigerated cushion
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Localized Neuropathic Pain
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Qutenza® without refrigerated cushion
Arm Type
No Intervention
Arm Description
Qutenza® without refrigerated cushion
Arm Title
Qutenza® with refrigerated cushion
Arm Type
Experimental
Arm Description
Qutenza® with refrigerated cushion
Intervention Type
Other
Intervention Name(s)
refrigerated cushion
Intervention Description
refrigerated cushion
Primary Outcome Measure Information:
Title
visual analogue pain scale (burning pain)
Description
visual analogue pain scale (burning pain)
Time Frame
after 1 hour of installation of Qutenza patch
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Major
Do not opposing the participation in the study
Monitoring in the case of localized neuropathic pain
Diagnostic with neuropathic pain score ≥ 4
Neuropathic pain conventional treatment failure of first-line
Front advantage of laying a first patch Qutenza®
With ability to understand the proposed study
Exclusion Criteria:
Patch Installation on the feet, face, mucous membranes
Eutectic mixture of local anesthetics (EMLA) Pose premedication
Having Already received prior to the installation of a patch of Qutenza®
Allergy to components Qutenza®
Known and poorly stabilized hypertension
Known cryoglobulinaemia
Pregnant or lactating women
Patient enjoying a measure of legal protection (guardianship, guardianship ...)
Private Patient freedom
No affiliation to a social security scheme.
Refusal to participate in the study
Facility Information:
Facility Name
CHLVO de Challans
City
Challans
ZIP/Postal Code
85300
Country
France
Facility Name
CHD Vendée de la Roche sur Yon
City
La Roche sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Clinique Brétéché
City
Nantes
ZIP/Postal Code
44000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Does the Application of Cold Decreases the Pain Associated in the Pose of a Patch of Capsaicine at High Concentration on the Carrier Patients of Localized Neuropathic Pains ? - DIDOCAP
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