Effect of Different Ultrasound Doses on Median Nerve Conduction Parameters

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05233488
Collaborator
(none)
120
4
5.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Pulsed Ultrasound Therapy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Four groups; First group receives pulsed US 1 W/cm2 10% duty cycle. Second group receives pulsed US 1 W/cm2 50% duty cycle. Third group receives pulsed US 3 W/cm2 10% duty cycle. Fourth group receives pulsed US 3 W/cm2 50% duty cycle.Four groups; First group receives pulsed US 1 W/cm2 10% duty cycle. Second group receives pulsed US 1 W/cm2 50% duty cycle. Third group receives pulsed US 3 W/cm2 10% duty cycle. Fourth group receives pulsed US 3 W/cm2 50% duty cycle.
Masking:
Double (Participant, Care Provider)
Masking Description:
Participant applicator are blinded to the US dose used.
Primary Purpose:
Treatment
Official Title:
Effect of Non-thermal Parameters of Ultrasound on Median Motor Nerve Conduction Velocity.
Anticipated Study Start Date :
Feb 12, 2022
Anticipated Primary Completion Date :
Jul 10, 2022
Anticipated Study Completion Date :
Aug 10, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Low US dose

Pulsed US, 1 W/cm2, 10% duty cycle.

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

Experimental: Intermediate US dose

Pulsed US, 1 W/cm2, 50% duty cycle.

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

Experimental: High US dose

Pulsed US, 3 W/cm2, 10% duty cycle.

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

Experimental: Higher US dose

Pulsed US, 3 W/cm2, 50% duty cycle.

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

Outcome Measures

Primary Outcome Measures

  1. CMAP distal latency [Immediately after application]

    msecond

  2. CMAP amplitude [Immediately after application]

    mV

  3. CMAP duration [Immediately after application]

    msecond

  4. Nerve conduction study [Immediately after application]

    m/sec.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 24 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

  • Principal Investigator: Amr S Shalaby, Ph.D., Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amr Saadeldeen Shalaby, Lecturer, Faculty of Physical Therapy, Cairo University
ClinicalTrials.gov Identifier:
NCT05233488
Other Study ID Numbers:
  • REC-43/02/008
First Posted:
Feb 10, 2022
Last Update Posted:
Feb 10, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Amr Saadeldeen Shalaby, Lecturer, Faculty of Physical Therapy, Cairo University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 10, 2022