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Interest of Ultrasonography in Electroneuromyography: Single-blind Randomised Controlled Clinical Trial (US ENMG)

C

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Conditions

Electromyoneurography

Treatments

Other: Electroneuromyography without ultrasound
Other: Electroneuromyography with ultrasound

Study type

Interventional

Funder types

Other

Identifiers

NCT03868189
2018-A02872-53 (Other Identifier)
NIMAO/2018-01/SC-01

Details and patient eligibility

About

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.

Enrollment

290 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

290 participants in 2 patient groups, including a placebo group

electroneuromyography
Experimental group
Treatment:
Other: Electroneuromyography with ultrasound
control
Placebo Comparator group
Treatment:
Other: Electroneuromyography without ultrasound

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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