- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05969093
Refining the Interpretation of the Tinel's Sign for Carpal Tunnel Syndrome
July 22, 2023 updated by: Mohamed Magdy ElMeligie, Ahram Canadian University
Refining the Interpretation of the Tinel's Sign for Carpal Tunnel Syndrome: An Electromyographic and Nerve Conduction Velocity Study
This is an observational study to investigate the electromyographic (EMG) activity and nerve conduction velocity (NCV) of healthy individuals during the Tinel's Sign performed at different wrist positions.
The study aims to identify the wrist position that best isolates median nerve activity during the Tinel's Sign.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The study will be conducted in a controlled laboratory setting, equipped with an electromyography (EMG) machine and a nerve conduction velocity (NCV) measurement device.
We will recruit 30 healthy adults, aged 18-45 years, with no history of hand or wrist pain, neurological or muscular disorders.
Participants will be excluded if they have any contraindications to EMG or NCV measurement.
The independent variable will be the wrist position during the Tinel's Sign, and the dependent variables will be the EMG activity of the thenar and hypothenar muscles and the NCV of the median and ulnar nerves.
EMG activity will be measured using surface electrodes placed on the thenar and hypothenar muscles.
NCV will be measured using a standard NCV measurement device.
To minimize bias, the same trained examiner will perform all tests and measurements, and the examiner will be blinded to the EMG and NCV data during the tests.
Differences in EMG activity and NCV across different wrist positions will be analyzed using repeated measures ANOVA.
Post-hoc pairwise comparisons will be performed using Bonferroni correction.
The study protocol will be submitted to the local ethics committee for approval, and all participants will provide informed consent.
Study Type
Observational
Enrollment (Estimated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mohamed M ElMeligie, Ph.d
- Phone Number: +201064442032
- Email: mohamed.elmeligie@acu.edu.eg
Study Locations
-
-
Giza
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Al Ḩayy Ath Thāmin, Giza, Egypt, 3221405
- Recruiting
- Outpatient clinic of faculty of physical therapy, Ahram Canadian University
-
Contact:
- Mohamed M ElMeligie, Ph.d
- Phone Number: 01064442032
- Email: mohamed.elmeligie@acu.edu.eg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Healthy individuals aged 18-60 years
Description
Inclusion Criteria:
- Healthy individuals aged 18-45 years
- No history of hand or wrist pain, neurological or muscular disorders
Exclusion Criteria:
- Any contraindications to EMG or NCV measurement
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healthy individuals
Participants will undergo the Tinel's Sign at different wrist positions while EMG activity and NCV are recorded.
|
Participants will undergo the Tinel's Sign at different wrist positions while EMG activity and NCV are recorded to investigate the effect of wrist position on median nerve activity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EMG activity of the thenar muscles during the Tinel's Sign performed at different wrist positions.
Time Frame: Baseline
|
The amplitude of EMG activity of the thenar muscles will be measured during the Tinel's Sign performed at different wrist positions.
The amplitude will be quantified in microvolts (µV).
|
Baseline
|
|
EMG activity of the hypothenar muscles during the Tinel's Sign performed at different wrist positions.
Time Frame: Baseline
|
The amplitude of EMG activity of the hypothenar muscles will be measured during the Tinel's Sign performed at different wrist positions.
The amplitude will be quantified in microvolts (µV).
|
Baseline
|
|
Nerve conduction velocity of the median nerve during the Tinel's Sign performed at different wrist positions.
Time Frame: Baseline
|
The NCV of the median nerve will be measured during the Tinel's Sign performed at different wrist positions.
The NCV will be quantified in meters per second (m/s).
|
Baseline
|
|
Nerve conduction velocity of the ulnar nerve during the Tinel's Sign performed at different wrist positions.
Time Frame: Baseline
|
The NCV of the ulnar nerve will be measured during the Tinel's Sign performed at different wrist positions.
The NCV will be quantified in meters per second (m/s).
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Amal Fawzy, Ph.d, Faculty of Physical Therapy, Ahram Canadian University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 29, 2023
Primary Completion (Estimated)
December 23, 2023
Study Completion (Estimated)
January 1, 2024
Study Registration Dates
First Submitted
July 22, 2023
First Submitted That Met QC Criteria
July 22, 2023
First Posted (Actual)
August 1, 2023
Study Record Updates
Last Update Posted (Actual)
August 1, 2023
Last Update Submitted That Met QC Criteria
July 22, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 012/TINEL2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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