- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06730724
Thenar Muscle Ultrasound in CTS Evaluation
December 9, 2024 updated by: Busra Sirin, Beylikduzu State Hospital
Is Ultrasound Measurement of Thenar Muscle Cross-Sectional Area Useful in the Evaluation of Carpal Tunnel Syndrome?: A Controlled Study
This study will include 20 patients aged 18-75 years who have been diagnosed with carpal tunnel syndrome (CTS) based on electrophysiological examinations performed within the last three months, as well as 20 healthy volunteers without a CTS diagnosis.
Sociodemographic data such as age, gender, height, weight, and BMI will be recorded.
Pinch grip strength will be evaluated using a Jamar pinch meter, and hand grip strength will be assessed using a Jamar dynamometer.
Ultrasound will be used to measure the cross-sectional area and thickness of the thenar muscles as well as the cross-sectional area of the median nerve.
Additionally, previous electrophysiological examination results will be recorded for the CTS patients.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
40
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: Büşra Şirin Ahısha, MD
- Phone Number: 02124443322
- Email: bsrn080@gmail.com
Study Locations
-
-
Beylikdüzü
-
Istanbul, Beylikdüzü, Turkey, 34147
- Beylikdüzü State Hospital
-
-
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
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
Carpal tunnel syndrome and healthy controls
Description
Inclusion Criteria:
- Patients aged 18-75 years.
- Diagnosed with carpal tunnel syndrome based on electrophysiological examination within the last 3 months.
- Healthy volunteers without a diagnosis of carpal tunnel syndrome.
- Volunteered to participate in the study.
Exclusion Criteria:
- Refusal to participate in the study.
- History of surgery due to carpal tunnel syndrome.
- Presence of neuromuscular diseases.
- Presence of advanced osteoarthritis.
- Presence of psychiatric disorders.
- Presence of cognitive impairments that may hinder study participation.
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 |
|---|---|
|
Carpal tunnel syndrome
Patients with carpal tunnel syndrome
|
No intervention
|
|
Control group
Healthy controls without carpal tunnel syndrome
|
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Thenar Muscle Cross-Sectional Area (Ultrasound)
Time Frame: 0 day
|
Measurement of the cross-sectional area of the thenar muscles using ultrasound to determine muscle atrophy or changes associated with carpal tunnel syndrome.
|
0 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Thenar Muscle Thickness (Ultrasound)
Time Frame: 0 day
|
Assessment of the thickness of the thenar muscles using ultrasound to evaluate structural changes in patients with CTS.
|
0 day
|
|
Median Nerve Cross-Sectional Area (Ultrasound)
Time Frame: 0 day
|
Measurement of the median nerve's cross-sectional area using ultrasound, a parameter commonly associated with CTS diagnosis and severity.
|
0 day
|
|
Pinch Grip Strength
Time Frame: 0 day
|
Evaluated using the Jamar pinch meter, this outcome measures the functional strength of the thumb and index finger, which may be impaired in CTS.
|
0 day
|
|
Hand Grip Strength
Time Frame: 0 day
|
Assessed with a Jamar dynamometer, this outcome measures overall hand strength and provides insights into functional limitations caused by CTS.
|
0 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Büşra Şirin Ahısha, Beylikdüzü State Hospital
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)
December 10, 2024
Primary Completion (Estimated)
January 10, 2025
Study Completion (Estimated)
January 10, 2025
Study Registration Dates
First Submitted
December 9, 2024
First Submitted That Met QC Criteria
December 9, 2024
First Posted (Estimated)
December 12, 2024
Study Record Updates
Last Update Posted (Estimated)
December 12, 2024
Last Update Submitted That Met QC Criteria
December 9, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BeylikduzuStateH12
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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