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OpenTrials
Completed

NCT Number: NCT02869867

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHLVO de Challans, Challans, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

refrigerated cushion

Other

refrigerated cushion

Primary outcomes

  1. 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?

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Departemental Vendee

Other

Registry information

Acronym: DIDOCAP

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 17, 2016
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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