Entrapment NeuropathiesNCT05233488
Effect of Different Ultrasound Doses on Median Nerve Conduction Parameters
A study testing Pulsed Ultrasound Therapy in people with Entrapment Neuropathies, run by Cairo University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Entrapment Neuropathies
- What is being tested?
- Pulsed Ultrasound Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Feb 2022to 10 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Peripheral polyneuropathy.
- Diabetes mellitus.
- Previous surgeries or median and/or ulnar nerve release.
- Cervical radiculopathy.
- Median or ulnar entrapment neuropathies.
- Previous or current pregnancies.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Giza, 18650
Amr S Shalaby, Ph.D., 01147718803, amr.saad@hotmail.com
Marwa MH Abousenna, M.Sc., 01153261600, marwa_hany@hotmail.com
About this study
Official title: 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.
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.
- Conditions
- Entrapment Neuropathies
- Being tested
- Pulsed Ultrasound Therapy
- Keywords
- Pulsed Ultrasound, Nerve conduction parameters.
- Medical subject headings
- Nerve Compression Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Ultrasound TherapyDevice
Ultrasound therapy is applied in the pulsed mode.
| Study group | Role | What they receive |
|---|---|---|
| Low US dose | Experimental | Pulsed US, 1 W/cm2, 10% duty cycle. Receives: Device: Pulsed Ultrasound Therapy |
| Intermediate US dose | Experimental | Pulsed US, 1 W/cm2, 50% duty cycle. Receives: Device: Pulsed Ultrasound Therapy |
| High US dose | Experimental | Pulsed US, 3 W/cm2, 10% duty cycle. Receives: Device: Pulsed Ultrasound Therapy |
| Higher US dose | Experimental | Pulsed US, 3 W/cm2, 50% duty cycle. Receives: Device: Pulsed Ultrasound Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
CMAP distal latency
msecond
Measured: Immediately after application
CMAP amplitude
mV
Measured: Immediately after application
CMAP duration
msecond
Measured: Immediately after application
Nerve conduction study
m/sec.
Measured: Immediately after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start12 Feb 2022
- Primary completion10 Nov 2023 (estimated)
- Study completion10 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Entrapment NeuropathiesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Saadeldeen Shalaby, Cairo University
- Investigators
- Amr S Shalaby, Ph.D., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233488
- Sponsor's protocol ID
- REC-43/02/008
- Status last verified
- Sep 2023
- First submitted
- 29 Jan 2022
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make IPD and related data dictionaries available.
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-thermal Parameters of Ultrasound on Median Motor Nerve Conduction Velocity.
- ClinicalTrials.gov ID
- NCT05233488
- Acronym / sponsor ID
- REC-43/02/008
- Conditions
- Entrapment Neuropathies
- Keywords
- Pulsed Ultrasound, Nerve conduction parameters.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Feb 2022 (actual)
- Primary completion
- 10 Nov 2023 (estimated)
- Study completion
- 10 Dec 2023 (estimated)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Low US dose | Experimental | Device: Pulsed Ultrasound TherapyPulsed US, 1 W/cm2, 10% duty cycle. |
| Intermediate US dose | Experimental | Device: Pulsed Ultrasound TherapyPulsed US, 1 W/cm2, 50% duty cycle. |
| High US dose | Experimental | Device: Pulsed Ultrasound TherapyPulsed US, 3 W/cm2, 10% duty cycle. |
| Higher US dose | Experimental | Device: Pulsed Ultrasound TherapyPulsed US, 3 W/cm2, 50% duty cycle. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- Peripheral polyneuropathy.
- Diabetes mellitus.
- Previous surgeries or median and/or ulnar nerve release.
- Cervical radiculopathy.
- Median or ulnar entrapment neuropathies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed Ultrasound TherapyUltrasound therapy is applied in the pulsed mode. | Device | High US dose, Higher US dose, Intermediate US dose, Low US dose |
Primary outcome
CMAP distal latency
Time frame: Immediately after application
msecond
CMAP amplitude
Time frame: Immediately after application
mV
CMAP duration
Time frame: Immediately after application
msecond
Nerve conduction study
Time frame: Immediately after application
m/sec.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amr S Shalaby, Ph.D. principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Ultrasound Therapy in people with Entrapment Neuropathies, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr S Shalaby, Ph.D. (00201147718803, amr.saad@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CMAP distal latency (time frame: Immediately after application). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.