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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
    • Giza
      • Al Ḩayy Ath Thāmin, Giza, Egypt, 3221405
        • Recruiting
        • Outpatient clinic of faculty of physical therapy, Ahram Canadian University
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Healthy individuals
Participants will undergo the Tinel's Sign at different wrist positions while EMG activity and NCV are recorded.
Diagnostic test: Tinel's Sign performed at different wrist positions
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ahram Canadian University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 29, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 23, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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