Effect of Different Ultrasound Doses on Median Nerve Conduction Parameters

NCT ID: NCT05233488

Last Updated: 2023-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-12

Study Completion Date

2023-12-10

Brief Summary

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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

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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.

Conditions

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Entrapment Neuropathies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
Participant applicator are blinded to the US dose used.

Study Groups

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Low US dose

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

Group Type EXPERIMENTAL

Pulsed Ultrasound Therapy

Intervention Type DEVICE

Ultrasound therapy is applied in the pulsed mode.

Intermediate US dose

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

Group Type EXPERIMENTAL

Pulsed Ultrasound Therapy

Intervention Type DEVICE

Ultrasound therapy is applied in the pulsed mode.

High US dose

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

Group Type EXPERIMENTAL

Pulsed Ultrasound Therapy

Intervention Type DEVICE

Ultrasound therapy is applied in the pulsed mode.

Higher US dose

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

Group Type EXPERIMENTAL

Pulsed Ultrasound Therapy

Intervention Type DEVICE

Ultrasound therapy is applied in the pulsed mode.

Interventions

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Pulsed Ultrasound Therapy

Ultrasound therapy is applied in the pulsed mode.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Amr Saadeldeen Shalaby

Lecturer, Faculty of Physical Therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amr S Shalaby, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Cairo University

Giza, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Amr S Shalaby, Ph.D.

Role: CONTACT

00201147718803

Marwa MH Abousenna, M.Sc.

Role: CONTACT

00201153261600

Facility Contacts

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Amr S Shalaby, Ph.D.

Role: primary

01147718803

Marwa MH Abousenna, M.Sc.

Role: backup

01153261600

Other Identifiers

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REC-43/02/008

Identifier Type: -

Identifier Source: org_study_id

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