ClinicalTrials.gg
Status unknownNCT05233488Updated Sep 6, 2023

Effect of Different Ultrasound Doses on Median Nerve Conduction Parameters

An interventional study of Pulsed Ultrasound Therapy in Entrapment Neuropathies, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-06.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 24 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Entrapment Neuropathies

Keywords

  • Pulsed Ultrasound
  • Nerve conduction parameters.
03

In context

Nerve Compression Syndromes

105 studies on the registry are indexed under Nerve Compression Syndromes; 13 are open to participants now.

This study's planned enrollment of 120 is above the median of 52 across 66 interventional studies indexed under Nerve Compression Syndromes.

Browse Nerve Compression Syndromes studies →

Lead sponsor

Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Low US dose

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

    Device: Pulsed Ultrasound Therapy

  • Experimental
    Intermediate US dose

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

    Device: Pulsed Ultrasound Therapy

  • Experimental
    High US dose

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

    Device: Pulsed Ultrasound Therapy

  • Experimental
    Higher US dose

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

    Device: Pulsed Ultrasound Therapy

Interventions

  • DevicePulsed Ultrasound Therapy

    Ultrasound therapy is applied in the pulsed mode.

06

What researchers measure

Primary outcomes

  1. CMAP distal latency

    msecond

    Time frame: Immediately after application

  2. CMAP amplitude

    mV

    Time frame: Immediately after application

  3. CMAP duration

    msecond

    Time frame: Immediately after application

  4. Nerve conduction study

    m/sec.

    Time frame: Immediately after application

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — There is a plan to make IPD and related data dictionaries available.

Supporting information: Study protocol, Clinical study report

Time frame: Within six months of termination of the current study.

Access criteria: IPD sharing will be done after publication of the study results

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05233488
Lead sponsor
Cairo University
Responsible party
Amr Saadeldeen Shalaby (Lecturer, Faculty of Physical Therapy, Cairo University) — Principal investigator
First posted
Feb 10, 2022
Start date
Feb 12, 2022
Primary completion
Nov 10, 2023 (estimated)
Completion
Dec 10, 2023 (estimated)
Last update
Sep 6, 2023

Study contacts

Amr S Shalaby, Ph.D.
Contact
amr.saad@pt.cu.edu.eg
00201147718803
Marwa MH Abousenna, M.Sc.
Contact
marwa_hany@hotmail.com
00201153261600
Amr S Shalaby, Ph.D.
principal investigator · Cairo University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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