Effect of Different Ultrasound Doses on Median Nerve Conduction Parameters

Not Applicable

Recruiting

• Conditions: Entrapment Neuropathies
• Interventions: Device: Pulsed Ultrasound Therapy

• Registration Number: NCT05233488
• Lead Sponsor: Cairo University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-01-29
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-10
• Study Start: 2022-02-12
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-05
• Last Update Posted: 2023-09-06
• Primary Completion: 2023-11-10
• Study Completion: 2023-12-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intermediate US dose	Pulsed Ultrasound Therapy	Pulsed US, 1 W/cm2, 50% duty cycle.
Low US dose	Pulsed Ultrasound Therapy	Pulsed US, 1 W/cm2, 10% duty cycle.
High US dose	Pulsed Ultrasound Therapy	Pulsed US, 3 W/cm2, 10% duty cycle.
Higher US dose	Pulsed Ultrasound Therapy	Pulsed US, 3 W/cm2, 50% duty cycle.

Primary Outcome Measures

Name	Time	Method
CMAP distal latency	Immediately after application	msecond
CMAP amplitude	Immediately after application	mV
CMAP duration	Immediately after application	msecond
Nerve conduction study	Immediately after application	m/sec.

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Giza, Egypt