Does the Application of Cold Decreases the Pain Associated in the Pose of a Patch of Capsaicine a… (NCT02869867) | Clinical Trial Compass
CompletedNot Applicable
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
France100 participantsStarted 2017-03-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Visual Analogue Pain Scale (Burning Pain)
Timeframe: after 1 hour of installation of Qutenza patch