Efficacity of a Standardized Hypnotic Message During the Application of a Qutenza (Capsaicin) 8% Patch

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-30

Study Completion Date

2019-07-13

Brief Summary

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QUTENZA® is a skin patch with a high concentration of capsaicin (8%) which is the component responsible for spicy peppers. QUTENZA® is indicated for the treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other analgesics. Acute pain experienced during and after the procedure can be relieved by local cooling methods and oral analgesics but the pain remains intense. The hypothesis is that hypnosis via a standardized hypnotic message would increase the local tolerance of the treatment when applying the patch QUTENZA®. To date, there are no studies that can confirm or refute this hypothesis.

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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arm 1

Patients, followed in the institut and for whom a new application of QUTENZA® is required, will receive standard care.

Group Type EXPERIMENTAL

QUTENZA®

Intervention Type DRUG

arm 2

Patients, followed in the institut and for whom a new application of QUTENZA® is required.

Patients will receive QUTENZA® according to standard procedure with a standardized hypnotic message

Group Type ACTIVE_COMPARATOR

QUTENZA®

Intervention Type DRUG

hypnotic message

Intervention Type OTHER

arm 3

Patients, followed in the institut and for whom a new application of QUTENZA® is required.

Patients will receive QUTENZA® according to standard procedure with a music therapy

Group Type PLACEBO_COMPARATOR

QUTENZA®

Intervention Type DRUG

music therapy

Intervention Type OTHER

Interventions

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QUTENZA®

Intervention Type DRUG

hypnotic message

Intervention Type OTHER

music therapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient who have already received at least a QUTENZA® patch
* Treatment for patient in failure to conventional treatments for neuropathic pain other than diabetics
* Age \>18 years
* Eastern Cooperative Oncology Group (ECOG) performance status \<3
* Patient must be affiliated to a social security system
* Ability to provide written informed consent
* Patient's legal capacity to consent to study participation and to understand and comply with the requirements of the study

Exclusion Criteria

* Patient with psychotic disorders
* Patient with hearing disorders
* Patient not understanding the French language
* Age \< 18 years
* Patient requiring analgesic premedication before applying the patch QUTENZA®
* Patient with a history of hypersensitivity to capsaicin or any of the excipients of the patch
* Patient deprived of liberty or under supervision

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No