NCT05233488

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

February 12, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2023

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

1.7 years

First QC Date

January 29, 2022

Last Update Submit

September 5, 2023

Conditions

Entrapment Neuropathies

Keywords

Pulsed UltrasoundNerve conduction parameters.

Outcome Measures

Primary Outcomes (4)

  • CMAP distal latency

    msecond

    Immediately after application

  • CMAP amplitude

    mV

    Immediately after application

  • CMAP duration

    msecond

    Immediately after application

  • Nerve conduction study

    m/sec.

    Immediately after application

Study Arms (4)

Low US dose

EXPERIMENTAL

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

Device: Pulsed Ultrasound Therapy

Intermediate US dose

EXPERIMENTAL

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

Device: Pulsed Ultrasound Therapy

High US dose

EXPERIMENTAL

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

Device: Pulsed Ultrasound Therapy

Higher US dose

EXPERIMENTAL

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

Device: Pulsed Ultrasound Therapy

Interventions

Pulsed Ultrasound TherapyDEVICE

Ultrasound therapy is applied in the pulsed mode.

High US doseHigher US doseIntermediate US doseLow US dose

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • hands of 60 subjects of both genders with age range 18: 24 years.
  • Subjects assigned will be apparently healthy subjects with no neurological or neuromuscular history affecting the upper limb.

You may not qualify if:

  • Peripheral polyneuropathy.
  • Diabetes mellitus.
  • Previous surgeries or median and/or ulnar nerve release.
  • Cervical radiculopathy.
  • Median or ulnar entrapment neuropathies.
  • Previous or current pregnancies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, 18650, Egypt

RECRUITING

MeSH Terms

Conditions

Nerve Compression Syndromes

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Amr S Shalaby, Ph.D.

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amr S Shalaby, Ph.D.

CONTACT

00201147718803amr.saad@pt.cu.edu.eg

Marwa MH Abousenna, M.Sc.

CONTACT

00201153261600marwa_hany@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Participant applicator are blinded to the US dose used.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, Faculty of Physical Therapy

Study Record Dates

First Submitted

January 29, 2022

First Posted

February 10, 2022

Study Start

February 12, 2022

Primary Completion

November 10, 2023

Study Completion

December 10, 2023

Last Updated

September 6, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
Within six months of termination of the current study.
Access Criteria
IPD sharing will be done after publication of the study results

Locations

EG(1)