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

• Sponsor: Centre Hospitalier Departemental Vendee (Other)
• Overall Status: Completed
• CT.gov ID: NCT02869867
• Collaborator: (none)
• Enrollment: 100
• Locations: 3
• Arms: 2
• Actual Duration (Months): 45.1
• Patients Per Site: 33.3
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Localized Neuropathic Pain	Other: refrigerated cushion	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: Mar 2, 2017
• Actual Primary Completion Date: Dec 4, 2020
• Actual Study Completion Date: Dec 4, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. visual analogue pain scale (burning pain) [after 1 hour of installation of Qutenza patch]

   visual analogue pain scale (burning pain)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHLVO de Challans	Challans		France	85300
2	CHD Vendée de la Roche sur Yon	La Roche sur Yon		France	85925
3	Clinique Brétéché	Nantes		France	44000

Sponsors and Collaborators

• Centre Hospitalier Departemental Vendee

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Departemental Vendee
• ClinicalTrials.gov Identifier: NCT02869867
• Other Study ID Numbers: CHD049-16
• First Posted: Aug 17, 2016
• Last Update Posted: Jan 13, 2021
• Last Verified: Jan 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neuralgia

Study Results

No Results Posted as of Jan 13, 2021