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 (DIDOCAP)

January 12, 2021 updated by: Centre Hospitalier Departemental Vendee

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Challans, France, 85300
        • CHLVO de Challans
      • La Roche sur Yon, France, 85925
        • CHD Vendée de la Roche sur Yon
      • Nantes, France, 44000
        • Clinique Breteche

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Qutenza® without refrigerated cushion
Experimental: Qutenza® with refrigerated cushion
Other: refrigerated cushion
refrigerated cushion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual analogue pain scale (burning pain)
Time Frame: after 1 hour of installation of Qutenza patch
visual analogue pain scale (burning pain)
after 1 hour of installation of Qutenza patch

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Departemental Vendee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2017

Primary Completion (Actual)

December 4, 2020

Study Completion (Actual)

December 4, 2020

Study Registration Dates

First Submitted

August 12, 2016

First Submitted That Met QC Criteria

August 16, 2016

First Posted (Estimate)

August 17, 2016

Study Record Updates

Last Update Posted (Actual)

January 13, 2021

Last Update Submitted That Met QC Criteria

January 12, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHD049-16

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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