Effect of Different Ultrasound Doses on Median Nerve Conduction Parameters

September 5, 2023 updated by: Amr Saadeldeen Shalaby, Cairo University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 24 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CMAP distal latency
Time Frame: Immediately after application
msecond
Immediately after application
CMAP amplitude
Time Frame: Immediately after application
mV
Immediately after application
CMAP duration
Time Frame: Immediately after application
msecond
Immediately after application
Nerve conduction study
Time Frame: Immediately after application
m/sec.
Immediately after application

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2022

Primary Completion (Estimated)

November 10, 2023

Study Completion (Estimated)

December 10, 2023

Study Registration Dates

First Submitted

January 29, 2022

First Submitted That Met QC Criteria

February 9, 2022

First Posted (Actual)

February 10, 2022

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 5, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC-43/02/008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

There is a plan to make IPD and related data dictionaries available.

IPD Sharing Time Frame

Within six months of termination of the current study.

IPD Sharing Access Criteria

IPD sharing will be done after publication of the study results

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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