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

Pain Clinical Trial

— ENHYZA  

Official title:

Efficacity of a Standardized Hypnotic Message on Pain Experienced During the Application of a Qutenza (Capsaicin) 8% Patch in Patients With Peripheral Neuropathic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02822625
• Other study ID #: 2016-A00234-47
• Status: Completed
• Phase: Phase 3
• Start date: August 30, 2016
• Est. completion date: July 13, 2019

Study information

• Verified date: March 2022
• Source: Institut de Cancérologie de Lorraine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: July 13, 2019
• Est. primary completion date: July 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• QUTENZA®

Other:
• hypnotic message

• music therapy

Locations

Country	Name	City	State
France	Institut de Cancérologie de Lorraine	Vandoeuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de Lorraine

Country where clinical trial is conducted

France, 

References & Publications (1)

Etienne R, Laurent M, Henry A, Bioy A, Salleron J, Schohn CH, Cretineau N. Interest of a standardized hypnotic message for the reduction of pain and anxiety in cancer patients treated by capsaicin patch for neuropathic pain: a randomized controlled trial. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare pain induced by patch QUTENZA®	Pain will be evaluated by a numerical scale before, just after, and after installation of the patch	1 day
Secondary	Compare anxiety induced by patch QUTENZA®	Anxiety will be evaluated by a numerical scale before, just after, and after installation of the patch	1 day
Secondary	Compare the real time of application of the patch		1 day
Secondary	Determine the number of patients who listened the message in totality.		1 day
Secondary	Compare the percentage of patients with a sensation of time distortion		1 day