Carpal Tunnel SyndromeNCT05965791
Median Nerve Function During Phalen's Test
An observational study of Carpal Tunnel Syndrome, run by Ahram Canadian University at 1 site in Egypt.
Trial summary
This study will use electromyography and nerve conduction studies to evaluate median nerve function during the Phalen's wrist flexion test in different wrist positions. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Phalen's wrist flexion test
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jul 2023to 15 Dec 2023
- Phase
- Observational
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy men and women aged 18-45 recruited from the local community.
Who may be able to join
- Healthy adults aged 18-45 years
- No history of hand/wrist disorders
Who cannot join
- Contraindications to EMG or NCV
- Neurological or muscular disorders
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
Al Ḩayy Ath Thāmin, Giza Governorate, 3221405
Mohamed M ElMeligie, Ph.d, 01064442032, mohamed.elmeligie@acu.edu.eg
About this study
Official title: Electrophysiological Assessment of the Median Nerve During the Phalen's Test for Carpal Tunnel Syndrome
This study will use electromyography and nerve conduction studies to evaluate median nerve function during the Phalen's wrist flexion test in different wrist positions.
Read the detailed description
The Phalen's test is commonly used to assess carpal tunnel syndrome. However, it is unclear which wrist position during this test best isolates median nerve function. This study will measure thenar muscle activation and median nerve conduction in 30 healthy participants performing the Phalen's test. Different wrist flexion angles will be evaluated to determine which position optimally targets the median nerve. Results may enhance utilization of the Phalen's test in clinical practice and research.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Phalen's wrist flexion test
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phalen's wrist flexion testDiagnostic test
The Phalen's test will be performed at different wrist flexion angles from 0 to 90 degrees.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Adults | 30 healthy adult participants aged 18-45 years performing the Phalen's wrist flexion test Receives: Diagnostic Test: Phalen's wrist flexion test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thenar Muscle Activation
Mean EMG activity of the thenar muscles during the Phalen's test at different wrist angles. Measured in microvolts (μV).
Measured: Baseline
Median Nerve Conduction Velocity during Phalen's Test
Median nerve conduction velocity (measured in meters per second, m/s) assessed using surface electrodes at the wrist and elbow during the Phalen's test wrist flexion maneuver. Measured bilaterally at each wrist flexion angle during a single study visit.
Measured: Baseline
Median Nerve Distal Latency during Phalen's Test
Median nerve distal latency (measured in milliseconds, ms) assessed using surface electrodes over the abductor pollicis brevis and stimulating the median nerve at the wrist during the Phalen's test. Measured bilaterally at each wrist flexion angle during a single study visit.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start25 Jul 2023 (estimated)
- Primary completion25 Nov 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy ElMeligie, Ahram Canadian University
- Investigators
- Amal Fawzy, Ph.d, Study chair, Faculty of Physical Therapy, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965791
- Sponsor's protocol ID
- OT-PT-001
- Status last verified
- Jul 2023
- First submitted
- 20 Jul 2023
- Last updated
- 28 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological Assessment of the Median Nerve During the Phalen's Test for Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT05965791
- Acronym / sponsor ID
- OT-PT-001
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 25 Jul 2023 (estimated)
- Primary completion
- 25 Nov 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 28 Jul 2023 (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.
This study will use electromyography and nerve conduction studies to evaluate median nerve function during the Phalen's wrist flexion test in different wrist positions.
Detailed description
The Phalen's test is commonly used to assess carpal tunnel syndrome. However, it is unclear which wrist position during this test best isolates median nerve function. This study will measure thenar muscle activation and median nerve conduction in 30 healthy participants performing the Phalen's test. Different wrist flexion angles will be evaluated to determine which position optimally targets the median nerve. Results may enhance utilization of the Phalen's test in clinical practice and research.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Adults | – | Diagnostic Test: Phalen's wrist flexion test30 healthy adult participants aged 18-45 years performing the Phalen's wrist flexion test |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy men and women aged 18-45 recruited from the local community.
Key inclusion criteria (2 listed)
- Healthy adults aged 18-45 years
- No history of hand/wrist disorders
Key exclusion criteria (2 listed)
- Contraindications to EMG or NCV
- Neurological or muscular disorders
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 |
|---|---|---|
| Phalen's wrist flexion testThe Phalen's test will be performed at different wrist flexion angles from 0 to 90 degrees. | Diagnostic test | Healthy Adults |
Primary outcome
Thenar Muscle Activation
Time frame: Baseline
Mean EMG activity of the thenar muscles during the Phalen's test at different wrist angles. Measured in microvolts (μV).
Median Nerve Conduction Velocity during Phalen's Test
Time frame: Baseline
Median nerve conduction velocity (measured in meters per second, m/s) assessed using surface electrodes at the wrist and elbow during the Phalen's test wrist flexion maneuver. Measured bilaterally at each wrist flexion angle during a single study visit.
Median Nerve Distal Latency during Phalen's Test
Time frame: Baseline
Median nerve distal latency (measured in milliseconds, ms) assessed using surface electrodes over the abductor pollicis brevis and stimulating the median nerve at the wrist during the Phalen's test. Measured bilaterally at each wrist flexion angle during a single study visit.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Amal Fawzy, Ph.d study chair
Faculty of Physical Therapy, Ahram Canadian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel Syndrome, run by Ahram Canadian 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 2 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 28 Jul 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 Mohamed M ElMeligie, Ph.d (+201064442032, mohamed.elmeligie@acu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thenar Muscle Activation (time frame: Baseline). The study lists 3 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 28 Jul 2023.