Vascular and Neurologic Exploration of Small Nervous Fiber by Sudoscanner and QST

NCT ID: NCT03044340

Last Updated: 2019-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-12
• Study Completion Date: 2019-04-17

Brief Summary

Erythromelalgy (EM) is a vascular syndrome very rare affecting the feet. This disease evolve by crisis when the feet extremities become red hot and painful. There are several types of EM but this study concern the adult primitive form. For a long time, the physiopathology was not described but now we know that there is a vascular form, with microcirculatory dysfunction and a neurologic form with small fibers neuropathy. The diagnostic of neurologic form is based on clinical evaluation (DN4 questionnaire, UENS scale...) and an electromyography. Thermotest, a medical device which measure the thermic sensitivity is used to quantify neuropathy. More recently Sudoscan, a device measuring cutaneous impedance to chloride ions detect small nervous fiber in diabetic patients with good correlation with Thermotest.

The purpose of this study is to analyze the vascular side and the neurologic side on patients consulting for Erythromelalgy.

Conditions

Erythermalgia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

erythermalgia patient

patient will be measured chlorine ions impedance with the SUDOSCAN and evaluation on pain du to temperature with the THERMOTEST

Group Type: EXPERIMENTAL

impedance measurement and pain evaluation

Intervention Type: OTHER

Measurement of chlorine ions impedance by SUDOSCAN and pain due to temperature evaluation with THERMOTEST

Interventions

impedance measurement and pain evaluation

Measurement of chlorine ions impedance by SUDOSCAN and pain due to temperature evaluation with THERMOTEST

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Pain with burn feeling at hands and feet extremities
• Crisis activated by the heat
• Age > 18 years old

Exclusion Criteria

• Patients who had burn in extremities

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Hôpital Saint-Joseph

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, France

Countries

France

Other Identifiers

ERYTHROMELALGY

Identifier Type: -

Identifier Source: org_study_id