Effect of Different Ultrasound Doses on Median Nerve Conduction Parameters

Entrapment Neuropathies Clinical Trial

Official title:

Effect of Non-thermal Parameters of Ultrasound on Median Motor Nerve Conduction Velocity.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05233488
• Other study ID #: REC-43/02/008
• Status: Recruiting
• Phase: N/A
• Start date: February 12, 2022
• Est. completion date: December 10, 2023

Study information

• Verified date: September 2023
• Source: Cairo University
• Contact: Amr S Shalaby, Ph.D.
• Phone: 00201147718803
• Email: amr.saad[@]pt.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current study investigates the effect of different doses of pulses ultrasound therapy on different nerve conduction parameters of the median nerve in healthy volunteering subjects.

Description:

In the current study, we apply pulsed ultrasound therapy on median nerves of healthy volunteer subjects, at 1 W/cm2 10% duty cycle, 3 W/cm2 10% duty cycle, 1 W/cm2 50% duty cycle, and 3 w/cm2 50% duty cycle. Parameters of median nerve conduction study, Latency, amplitude, area, duration and forearm NCV are recorded before and after application of ultrasound therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 10, 2023
• Est. primary completion date: November 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

Inclusion Criteria:

1. 120 hands of 60 subjects of both genders with age range 18: 24 years.

2. Subjects assigned will be apparently healthy subjects with no neurological or neuromuscular history affecting the upper limb.

Exclusion Criteria:

1. Peripheral polyneuropathy.

2. Diabetes mellitus.

3. Previous surgeries or median and/or ulnar nerve release.

4. Cervical radiculopathy.

5. Median or ulnar entrapment neuropathies.

6. Previous or current pregnancies.

Related Conditions & MeSH terms

• Charcot-Marie-Tooth Disease
• Entrapment Neuropathies
• Hereditary Sensory and Motor Neuropathy
• Nerve Compression Syndromes

Intervention

Device:
• Pulsed Ultrasound Therapy
Ultrasound therapy is applied in the pulsed mode.

Locations

Country	Name	City	State
Egypt	Cairo University	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CMAP distal latency	msecond	Immediately after application
Primary	CMAP amplitude	mV	Immediately after application
Primary	CMAP duration	msecond	Immediately after application
Primary	Nerve conduction study	m/sec.	Immediately after application