Interest of Ultrasonography in Electroneuromyography: Single-blind Randomised Controlled Clinical Trial

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

NA

Total Enrollment

290 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-04

Study Completion Date

2020-06-11

Brief Summary

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Echo-nerve tracking during an electroneuromyographic (ENMG) examination by identifying the optimal stimulation site would reduce the stimulation intensities delivered to the patient and thus improve the tolerance of this examination.

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Detailed Description

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Conditions

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Electromyoneurography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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electroneuromyography

Group Type EXPERIMENTAL

Electroneuromyography with ultrasound

Intervention Type OTHER

Patients whose electroneuromyography examination will be performed using an ultrasound

control

Group Type PLACEBO_COMPARATOR

Electroneuromyography without ultrasound

Intervention Type OTHER

Patients whose electroneuromyography examination will be performed without ultrasound (fake tracking)

Interventions

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Electroneuromyography with ultrasound

Patients whose electroneuromyography examination will be performed using an ultrasound

Intervention Type OTHER

Electroneuromyography without ultrasound

Patients whose electroneuromyography examination will be performed without ultrasound (fake tracking)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient requiring an electroneuromyogram whose indication allows the application of a standard protocol of examination.
* Patient that has given his/her free and informed consent.
* Patient that signed the consent form.
* Patient with an health insurance plan.
* The patient is at least 18 years old (≥).
* he patient is under 80 years old (≤).

Exclusion Criteria

* Patient with symptoms of neuropathy during the screening.
* Patient whose Neurological severity score (NSS) score is ≥ 3.
* Patient whose neurological examination is abnormal and suggestive of neuropathy.
* Patient presenting a pathology that could cause neuropathy (e.g. diabetes, renal failure, etc.).
* Patient already participating in a category 1 research study (Jardé law).
* Patient in an exclusion period determined by another study.
* Patient under the protection of justice, under guardianship or under curatorship.
* Patient refusing to sign the consent form.
* Patient for which it is impossible to provide information about the study.
* Pregnant patient, parturient, or breastfeeding.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No