Effect of Different Ultrasound Doses on Median Nerve Conduction Parameters
Primary Purpose
Entrapment Neuropathies
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pulsed Ultrasound Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Entrapment Neuropathies focused on measuring Pulsed Ultrasound, Nerve conduction parameters.
Eligibility Criteria
Inclusion Criteria:
- 120 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.
Exclusion Criteria:
- Peripheral polyneuropathy.
- Diabetes mellitus.
- Previous surgeries or median and/or ulnar nerve release.
- Cervical radiculopathy.
- Median or ulnar entrapment neuropathies.
- Previous or current pregnancies.
Sites / Locations
- Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Low US dose
Intermediate US dose
High US dose
Higher US dose
Arm Description
Pulsed US, 1 W/cm2, 10% duty cycle.
Pulsed US, 1 W/cm2, 50% duty cycle.
Pulsed US, 3 W/cm2, 10% duty cycle.
Pulsed US, 3 W/cm2, 50% duty cycle.
Outcomes
Primary Outcome Measures
CMAP distal latency
msecond
CMAP amplitude
mV
CMAP duration
msecond
Nerve conduction study
m/sec.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05233488
Brief Title
Effect of Different Ultrasound Doses on Median Nerve Conduction Parameters
Official Title
Effect of Non-thermal Parameters of Ultrasound on Median Motor Nerve Conduction Velocity.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 12, 2022 (Actual)
Primary Completion Date
November 10, 2023 (Anticipated)
Study Completion Date
December 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Entrapment Neuropathies
Keywords
Pulsed Ultrasound, Nerve conduction parameters.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare Provider
Masking Description
Participant applicator are blinded to the US dose used.
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low US dose
Arm Type
Experimental
Arm Description
Pulsed US, 1 W/cm2, 10% duty cycle.
Arm Title
Intermediate US dose
Arm Type
Experimental
Arm Description
Pulsed US, 1 W/cm2, 50% duty cycle.
Arm Title
High US dose
Arm Type
Experimental
Arm Description
Pulsed US, 3 W/cm2, 10% duty cycle.
Arm Title
Higher US dose
Arm Type
Experimental
Arm Description
Pulsed US, 3 W/cm2, 50% duty cycle.
Intervention Type
Device
Intervention Name(s)
Pulsed Ultrasound Therapy
Intervention Description
Ultrasound therapy is applied in the pulsed mode.
Primary Outcome Measure Information:
Title
CMAP distal latency
Description
msecond
Time Frame
Immediately after application
Title
CMAP amplitude
Description
mV
Time Frame
Immediately after application
Title
CMAP duration
Description
msecond
Time Frame
Immediately after application
Title
Nerve conduction study
Description
m/sec.
Time Frame
Immediately after application
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
120 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.
Exclusion Criteria:
Peripheral polyneuropathy.
Diabetes mellitus.
Previous surgeries or median and/or ulnar nerve release.
Cervical radiculopathy.
Median or ulnar entrapment neuropathies.
Previous or current pregnancies.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amr S Shalaby, Ph.D.
Phone
00201147718803
Email
amr.saad@pt.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Marwa MH Abousenna, M.Sc.
Phone
00201153261600
Email
marwa_hany@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr S Shalaby, Ph.D.
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Giza
ZIP/Postal Code
18650
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amr S Shalaby, Ph.D.
Phone
01147718803
Email
amr.saad@hotmail.com
First Name & Middle Initial & Last Name & Degree
Marwa MH Abousenna, M.Sc.
Phone
01153261600
Email
marwa_hany@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Effect of Different Ultrasound Doses on Median Nerve Conduction Parameters
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