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

Not Applicable

Completed

• Conditions: Localized Neuropathic Pain
• Interventions: Other: refrigerated cushion

• Registration Number: NCT02869867
• Lead Sponsor: Centre Hospitalier Departemental Vendee

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-12
• Study First Submitted QC: 2016-08-16
• Study First Posted: 2016-08-17
• Study Start: 2017-03-02
• Primary Completion: 2020-12-04
• Study Completion: 2020-12-04
• Status Verified: 2021-01
• Results First Submitted: 2023-06-15
• Results First Submitted QC: 2024-03-15
• Last Update Submitted: 2024-03-15
• Results First Posted: 2024-08-15
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Qutenza® with refrigerated cushion	refrigerated cushion	Qutenza® with refrigerated cushion

Primary Outcome Measures

Name	Time	Method
Visual Analogue Pain Scale (Burning Pain)	after 1 hour of installation of Qutenza patch	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?

Trial Locations

Locations (3)

CHLVO de Challans; 🇫🇷 Challans, France

CHD Vendée de la Roche sur Yon; 🇫🇷 La Roche sur Yon, France

Clinique Brétéché; 🇫🇷 Nantes, France