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

Centre Hospitalier Departemental Vendee

Status: Completed

Conditions: Localized Neuropathic Pain

Treatments: Other: refrigerated cushion

Study type: Interventional

Funder types: Other

Identifiers

NCT02869867

CHD049-16

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Qutenza® without refrigerated cushion

No Intervention group

Description:

Qutenza® without refrigerated cushion

Qutenza® with refrigerated cushion

Experimental group

Description:

Qutenza® with refrigerated cushion

Treatment:

Other: refrigerated cushion