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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05969093
Other study ID # 012/TINEL2023
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 29, 2023
Est. completion date January 1, 2024

Study information

Verified date July 2023
Source Ahram Canadian University
Contact Mohamed M ElMeligie, Ph.d
Phone +201064442032
Email mohamed.elmeligie@acu.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date January 1, 2024
Est. primary completion date December 23, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Egypt Outpatient clinic of faculty of physical therapy, Ahram Canadian University Al ?ayy Ath Thamin Giza

Sponsors (1)

Lead Sponsor Collaborator
Ahram Canadian University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary EMG activity of the thenar muscles during the Tinel's Sign performed at different wrist positions. 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
Primary EMG activity of the hypothenar muscles during the Tinel's Sign performed at different wrist positions. 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
Primary Nerve conduction velocity of the median nerve during the Tinel's Sign performed at different wrist positions. 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
Primary Nerve conduction velocity of the ulnar nerve during the Tinel's Sign performed at different wrist positions. 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
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