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

Localized Neuropathic Pain Clinical Trial

— DIDOCAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02869867
• Other study ID #: CHD049-16
• Status: Completed
• Phase: N/A
• Start date: March 2, 2017
• Est. completion date: December 4, 2020

Study information

• Verified date: January 2021
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 4, 2020
• Est. primary completion date: December 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Localized Neuropathic Pain
• Neuralgia

Intervention

Other:
• refrigerated cushion
refrigerated cushion

Locations

Country	Name	City	State
France	CHLVO de Challans	Challans
France	CHD Vendée de la Roche sur Yon	La Roche sur Yon
France	Clinique Brétéché	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analogue pain scale (burning pain)	visual analogue pain scale (burning pain)	after 1 hour of installation of Qutenza patch