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

Not Applicable

Completed

• Conditions: Electromyoneurography
• Interventions: Other: Electroneuromyography with ultrasound; Other: Electroneuromyography without ultrasound

• Registration Number: NCT03868189
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-07
• Study First Submitted QC: 2019-03-07
• Study First Posted: 2019-03-11
• Study Start: 2019-04-04
• Primary Completion: 2020-01-28
• Study Completion: 2020-11-11
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-04
• Last Update Posted: 2021-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 290

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
electroneuromyography	Electroneuromyography with ultrasound	-
control	Electroneuromyography without ultrasound	-

Primary Outcome Measures

Name	Time	Method
Supra-maximal stimulation intensity delivered by stimulation site on sensory nerves	Day 0	unit : milliampere (mA)

Secondary Outcome Measures

Name	Time	Method
Average time per explored site (total duration divided by the number of explored nerves and muscles)	Day 0	unit : minutes
Supra-maximal stimulation intensity delivered by stimulation site on the motor nerves	Day 0	unit : mA
Motor Amplitude per collection site	Day 0	unit : Millivolts (mV)
Score of satisfaction	Day 0	Likert scale that range from 1 ("not satisfied at all ") to 4 ("totally satisfied")
Sensitivity Amplitude per collection site	Day 0	unit : microvolts (uV)
Number of explored unusual muscles	Day 0	unit : number
Overall examination time between the beginning of the stimulation and the end of the myography examination	Day 0	unit : minutes
Measurement of felt pain	Day 0	Analogical visual scale of pain from 1 (no pain) to 100 (maximum pain)
Total number of explored muscles	Day 0	unit : number

Trial Locations

Locations (2)

Nîmes University Hospital; 🇫🇷 Nîmes, France

CHU Nîmes; 🇫🇷 Nîmes, France