Carpal Tunnel SyndromeNCT07752797
Assessment of Ultrasound Findings, Nerve Test Results, and Hand Function in Patients With Carpal Tunnel Syndrome
An observational study of Carpal Tunnel Syndrome, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Carpal tunnel syndrome is one of the most common conditions caused by compression of a nerve at the wrist. It can lead to numbness, tingling, pain, weakness, and difficulty performing daily activities. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Ultrasonographic and Clinical Assessment
- How many people
- 109 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 31 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Adult, Older adult
Study population: The study population will consist of adult patients (≥18 years) with clinically suspected and electrophysiologically confirmed carpal tunnel syndrome who are evaluated in the Physical Medicine and Rehabilitation outpatient clinic. Participants will be classified into mild, moderate, and severe groups according to electrophysiological severity.
Who may be able to join
- Adults aged 18 years or older
- Clinical findings consistent with carpal tunnel syndrome
- Carpal tunnel syndrome confirmed by electroneuromyography
- Ability to understand and complete the study assessments
- Provision of written informed consent
Who cannot join
- Previous carpal tunnel release surgery
- History of fracture, major trauma, or surgery involving the assessed wrist or hand
- Cervical radiculopathy, brachial plexopathy, or other peripheral neuropathy affecting the upper extremity
- Polyneuropathy
- Inflammatory rheumatic disease or active infection involving the assessed upper extremity
- Severe neurological or musculoskeletal disorder that may affect hand function
- Inability to complete ultrasonographic, electrophysiological, functional, or questionnaire assessments
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Suleyman Education and Research Hospital
Küçükçekmece, Istanbul, 34307
About this study
Official title: Association of Clinical Severity With Ultrasonographic, Electrophysiological, and Functional Parameters in Patients With Carpal Tunnel Syndrome: A Cross-Sectional Observational Study
Carpal tunnel syndrome is one of the most common conditions caused by compression of a nerve at the wrist. It can lead to numbness, tingling, pain, weakness, and difficulty performing daily activities. Although nerve conduction studies are widely used to confirm the diagnosis and assess disease severity, ultrasonography has become an increasingly important, non-invasive diagnostic tool. However, the relationship between ultrasound findings, nerve conduction study results, hand function, and symptom severity has not been fully clarified.
The purpose of this study is to investigate the relationship between the clinical severity of carpal tunnel syndrome and ultrasonographic, electrophysiological, and functional parameters. Participants with carpal tunnel syndrome will undergo ultrasonographic measurement of the median nerve, nerve conduction studies, hand grip strength assessment, pressure pain threshold measurement, and completion of the Boston Carpal Tunnel Questionnaire.
The investigators hypothesize that greater clinical severity will be associated with larger median nerve cross-sectional area, more severe electrophysiological abnormalities, reduced hand grip strength, lower pressure pain threshold, and poorer functional status. The findings of this study may improve the understanding of the relationship between structural, electrophysiological, and functional changes in carpal tunnel syndrome and contribute to clinical evaluation and patient management.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Ultrasonographic and Clinical Assessment
- Keywords
- Median Nerve, Ultrasonography, Hand Grip Strength
- 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.
Ultrasonographic and Clinical AssessmentDiagnostic test
Participants will undergo a standardized diagnostic assessment including ultrasonographic measurement of the median nerve cross-sectional area at the carpal tunnel inlet, nerve conduction study evaluation, hand grip strength measurement using a Jamar dynamometer, pressure pain threshold assessment using a digital algometer, and completion of the Boston Carpal Tunnel Questionnaire. All assessments will be performed once during a single study visit. No therapeutic intervention will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Mild Carpal Tunnel Syndrome | Not described Receives: Diagnostic Test: Ultrasonographic and Clinical Assessment | |
| Moderate Carpal Tunnel Syndrome | Not described Receives: Diagnostic Test: Ultrasonographic and Clinical Assessment | |
| Severe Carpal Tunnel Syndrome | Not described Receives: Diagnostic Test: Ultrasonographic and Clinical Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Nerve Cross-Sectional Area Measured by Ultrasonography (mm²)
The median nerve cross-sectional area will be measured by high-resolution ultrasonography at the carpal tunnel inlet (pisiform level). The mean of three measurements will be recorded in square millimeters (mm²).
Measured: Baseline (prior to study assessments, during the single study visit)
Secondary outcomes (4)
Boston Carpal Tunnel Questionnaire Symptom Severity Score
Symptom severity will be assessed using the Boston Carpal Tunnel Questionnaire (BCTQ) Symptom Severity Scale. Scores range from 1 to 5, with higher scores indicating greater symptom severity.
Measured: Baseline (prior to study assessments, during the single study visit)
Boston Carpal Tunnel Questionnaire Functional Status Score
Functional status will be assessed using the Functional Status Scale of the Boston Carpal Tunnel Questionnaire (BCTQ-FSS). The questionnaire consists of 8 items evaluating difficulty in performing daily activities. Each item is scored from 1 (no difficulty) to 5 (cannot perform the activity), and the final score is calculated as the mean of all items. Higher scores indicate greater functional impairment.
Measured: Baseline (prior to study assessments, during the single study visit)
Hand Grip Strength Measured Using a Jamar Dynamometer (kg)
Maximum hand grip strength will be measured using a Jamar hydraulic hand dynamometer. The mean of three measurements will be recorded in kilograms (kg).
Measured: Baseline (prior to study assessments, during the single study visit)
Pressure Pain Threshold Measured Using a Digital Algometer (kPa)
Pressure pain threshold will be assessed using a digital pressure algometer. The mean of three measurements will be recorded in kPa
Measured: Baseline (prior to study assessments, during the single study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 Jun 2026
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Zehra FERHATLAR, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752797
- Sponsor's protocol ID
- PMR-KTS-2026-01
- Status last verified
- Sep 2026
- First submitted
- 29 Jul 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Clinical Severity With Ultrasonographic, Electrophysiological, and Functional Parameters in Patients With Carpal Tunnel Syndrome: A Cross-Sectional Observational Study
- ClinicalTrials.gov ID
- NCT07752797
- Acronym / sponsor ID
- PMR-KTS-2026-01
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Median Nerve, Ultrasonography, Hand Grip Strength
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 7 Aug 2026 (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.
Carpal tunnel syndrome is one of the most common conditions caused by compression of a nerve at the wrist. It can lead to numbness, tingling, pain, weakness, and difficulty performing daily activities. Although nerve conduction studies are widely used to confirm the diagnosis and assess disease severity, ultrasonography has become an increasingly important, non-invasive diagnostic tool. However, the relationship between ultrasound findings, nerve conduction study results, hand function, and symptom severity has not been fully clarified.
The purpose of this study is to investigate the relationship between the clinical severity of carpal tunnel syndrome and ultrasonographic, electrophysiological, and functional parameters. Participants with carpal tunnel syndrome will undergo ultrasonographic measurement of the median nerve, nerve conduction studies, hand grip strength assessment, pressure pain threshold measurement, and completion of the Boston Carpal Tunnel Questionnaire.
The investigators hypothesize that greater clinical severity will be associated with larger median nerve cross-sectional area, more severe electrophysiological abnormalities, reduced hand grip strength, lower pressure pain threshold, and poorer functional status. The findings of this study may improve the understanding of the relationship between structural, electrophysiological, and functional changes in carpal tunnel syndrome and contribute to clinical evaluation and patient management.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild Carpal Tunnel Syndrome | – | Diagnostic Test: Ultrasonographic and Clinical Assessment |
| Moderate Carpal Tunnel Syndrome | – | Diagnostic Test: Ultrasonographic and Clinical Assessment |
| Severe Carpal Tunnel Syndrome | – | Diagnostic Test: Ultrasonographic and Clinical Assessment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients (≥18 years) with clinically suspected and electrophysiologically confirmed carpal tunnel syndrome who are evaluated in the Physical Medicine and Rehabilitation outpatient clinic. Participants will be classified into mild, moderate, and severe groups according to electrophysiological severity.
Key inclusion criteria (5 listed)
- Adults aged 18 years or older
- Clinical findings consistent with carpal tunnel syndrome
- Carpal tunnel syndrome confirmed by electroneuromyography
- Ability to understand and complete the study assessments
- Provision of written informed consent
Key exclusion criteria (7 listed)
- Previous carpal tunnel release surgery
- History of fracture, major trauma, or surgery involving the assessed wrist or hand
- Cervical radiculopathy, brachial plexopathy, or other peripheral neuropathy affecting the upper extremity
- Polyneuropathy
- Inflammatory rheumatic disease or active infection involving the assessed upper extremity
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 |
|---|---|---|
| Ultrasonographic and Clinical AssessmentParticipants will undergo a standardized diagnostic assessment including ultrasonographic measurement of the median nerve cross-sectional area at the carpal tunnel inlet, nerve conduction study evaluation, hand grip strength measurement using a Jamar dynamometer, pressure pain threshold assessment using a digital algometer, and completion of the Boston Carpal Tunnel Questionnaire. All assessments will be performed once during a single study visit. No therapeutic intervention will be administered. | Diagnostic test | Mild Carpal Tunnel Syndrome, Moderate Carpal Tunnel Syndrome, Severe Carpal Tunnel Syndrome |
Primary outcome
Median Nerve Cross-Sectional Area Measured by Ultrasonography (mm²)
Time frame: Baseline (prior to study assessments, during the single study visit)
The median nerve cross-sectional area will be measured by high-resolution ultrasonography at the carpal tunnel inlet (pisiform level). The mean of three measurements will be recorded in square millimeters (mm²).
4 secondary outcomes
Boston Carpal Tunnel Questionnaire Symptom Severity Score
Time frame: Baseline (prior to study assessments, during the single study visit)
Boston Carpal Tunnel Questionnaire Functional Status Score
Time frame: Baseline (prior to study assessments, during the single study visit)
Hand Grip Strength Measured Using a Jamar Dynamometer (kg)
Time frame: Baseline (prior to study assessments, during the single study visit)
Pressure Pain Threshold Measured Using a Digital Algometer (kPa)
Time frame: Baseline (prior to study assessments, during the single study visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Kanuni Sultan Suleyman Training and Research 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 16 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Nerve Cross-Sectional Area Measured by Ultrasonography (mm²) (time frame: Baseline (prior to study assessments, during the single study visit)). 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 16 Sep 2026.