Carpal Tunnel SyndromeNCT06730724
Thenar Muscle Ultrasound in CTS Evaluation
An observational study of Carpal Tunnel Syndrome, run by Beylikduzu State Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2024to 10 Jan 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Adult, Older adult
Study population: Carpal tunnel syndrome and healthy controls
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Beylikdüzü State Hospital
Istanbul, Beylikdüzü, 34147
About this study
Official title: 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.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- No intervention
- 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.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Carpal tunnel syndrome | Patients with carpal tunnel syndrome Receives: Other: No intervention | |
| Control group | Healthy controls without carpal tunnel syndrome Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thenar Muscle Cross-Sectional Area (Ultrasound)
Measurement of the cross-sectional area of the thenar muscles using ultrasound to determine muscle atrophy or changes associated with carpal tunnel syndrome.
Measured: 0 day
Secondary outcomes (4)
Thenar Muscle Thickness (Ultrasound)
Assessment of the thickness of the thenar muscles using ultrasound to evaluate structural changes in patients with CTS.
Measured: 0 day
Median Nerve Cross-Sectional Area (Ultrasound)
Measurement of the median nerve's cross-sectional area using ultrasound, a parameter commonly associated with CTS diagnosis and severity.
Measured: 0 day
Pinch Grip Strength
Evaluated using the Jamar pinch meter, this outcome measures the functional strength of the thumb and index finger, which may be impaired in CTS.
Measured: 0 day
Hand Grip Strength
Assessed with a Jamar dynamometer, this outcome measures overall hand strength and provides insights into functional limitations caused by CTS.
Measured: 0 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start10 Dec 2024 (estimated)
- Primary completion10 Jan 2025 (estimated)
- Study completion10 Jan 2025 (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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Beylikduzu State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra Sirin, Beylikduzu State Hospital
- Investigators
- Büşra Şirin Ahısha, Principal investigator, Beylikdüzü State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730724
- Sponsor's protocol ID
- BeylikduzuStateH12
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- 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 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Ultrasound Measurement of Thenar Muscle Cross-Sectional Area Useful in the Evaluation of Carpal Tunnel Syndrome?: A Controlled Study
- ClinicalTrials.gov ID
- NCT06730724
- Acronym / sponsor ID
- BeylikduzuStateH12
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beylikduzu State HospitalUniversity, hospital or other
- Study start
- 10 Dec 2024 (estimated)
- Primary completion
- 10 Jan 2025 (estimated)
- Study completion
- 10 Jan 2025 (estimated)
- First posted
- 12 Dec 2024 (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 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carpal tunnel syndrome | – | Other: No interventionPatients with carpal tunnel syndrome |
| Control group | – | Other: No interventionHealthy controls without carpal tunnel syndrome |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Carpal tunnel syndrome and healthy controls
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| No interventionNo intervention | Other | Carpal tunnel syndrome, Control group |
Primary outcome
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.
4 secondary outcomes
Thenar Muscle Thickness (Ultrasound)
Time frame: 0 day
Median Nerve Cross-Sectional Area (Ultrasound)
Time frame: 0 day
Pinch Grip Strength
Time frame: 0 day
Hand Grip Strength
Time frame: 0 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Carpal Tunnel Syndrome
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Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
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Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
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Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
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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.
Büşra Şirin Ahısha principal investigator
Beylikdüzü State Hospital
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 Beylikduzu State Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 12 Dec 2024. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Büşra Şirin Ahısha, MD (02124443322, bsrn080@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thenar Muscle Cross-Sectional Area (Ultrasound) (time frame: 0 day). 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 12 Dec 2024.