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Clinical Trials/NCT02869867
NCT02869867
Completed
Not 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

Centre Hospitalier Departemental Vendee3 sites in 1 country100 target enrollmentMarch 2, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Localized Neuropathic Pain
Sponsor
Centre Hospitalier Departemental Vendee
Enrollment
100
Locations
3
Primary Endpoint
Visual Analogue Pain Scale (Burning Pain)
Status
Completed
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2, 2017
End Date
December 4, 2020
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Visual Analogue Pain Scale (Burning Pain)

Time Frame: 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?

Study Sites (3)

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