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Ultrasound may replace nerve tests for carpal tunnel diagnosis

NCT ID NCT07408596

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether ultrasound can accurately diagnose mild to moderate carpal tunnel syndrome (CTS) by measuring the median nerve. Researchers compared ultrasound results with standard nerve tests and checked how they related to pain, symptoms, and quality of life in 75 people. The goal is to see if ultrasound alone could be a reliable, non-invasive diagnostic tool.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could make diagnosing carpal tunnel syndrome faster and less invasive by using ultrasound instead of nerve tests.
What could go wrong
This is a small, completed study with 75 people, so results may not apply to everyone. Ultrasound might not replace standard tests in all cases.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

75 people

The number who actually took part.

Started

Jul 2025

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This cross-sectional analytical study is designed to include participants based on a power analysis and results from previous studies. To achieve 80% statistical power at a 95% confidence level, at least 68 participants are required; however, considering that a few participants may be excluded due to not meeting eligibility criteria, a total of 75 participants (150 hands) will be enrolled. The study will target individuals aged 18-60 years who present to the Physical Medicine and Rehabilitation outpatient clinic at İstanbul University, İstanbul Faculty of Medicine, Esnaf Hospital. Participants will include healthy individuals as well as patients diagnosed with mild to moderate carpal tunnel syndrome (CTS) based on clinical findings and electrophysiological evaluation. Before enrollment, all participants will be fully informed about the study, and written informed consent will be obtained. Demographic characteristics, including age, height, weight, will be recorded for all participants.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

INCLUSION CRITERIA: Participants aged 18-60 years who meet the eligibility criteria as either healthy controls or patients with carpal tunnel syndrome (CTS) are eligible for the study. 1. Healthy Participants: * Absence of any clinical symptoms related to CTS. * Normal evaluation according to electrophysiological criteria for CTS. 2. Participants with CTS: Participants must have a diagnosis of mild or moderate CTS based on clinical findings and electrophysiological evaluation. b.1) Clinical Findings/Symptoms: b.1.1) Symptoms: (A)- Sensory symptoms in the 1st, 2nd, 3rd finger, or lateral half of the 4th finger, or in any combination of these. (B)- Symptom relief with hand-shaking or squeezing movements. (C)- Pain or paresthesia triggered by hand grip or forceful hand use. (D)- Nocturnal paresthesia causing the patient to wake from sleep. b.1.2) Diagnostic Tests/Signs: * Tinel's sign * Phalen test * Reverse Phalen test * Carpal tunnel compression test * Flick sign Clinical CTS Diagnosis: Symptoms must be present for at least three months and at least the presence of sensory symptoms (A) plus at least one of B, C, or D, together with at least one positive diagnostic test/sign, is required for clinical diagnosis. b.2) Electrophysiological Evaluation: * Mild CTS: Median-ulnar sensory peak latency difference ≥ 0.4 ms in the 4th finger, and median sensory distal latency of the 2nd finger ≥ 2.8 ms, with conduction velocity \< 50 m/s. Sensory nerve action potential (SNAP) ≥ 12 μV. * Moderate CTS: Median distal motor latency of the 2nd finger between 4 ms and 5.5 ms, with conduction velocity \< 50 m/s. Compound muscle action potential (CMAP) ≥ 5 mV. E) EXCLUSİON CRİTERİA: 1. For Participants Meeting Patient Criteria: * Participants diagnosed with mild or moderate CTS who meet any of the following criteria will be excluded: * History of physical therapy for carpal tunnel syndrome within the last 6 months. * History of injection into the carpal tunnel. * History of carpal tunnel release surgery. * Presence of thenar atrophy in the hand. * History of cardiac pacemaker implantation. * History of lymphedema in the studied extremity. * History of cervical radiculopathy. * Presence of tenosynovitis in the ipsilateral upper extremity. * Presence of another compressive neuropathy in the ipsilateral upper extremity. * History of peripheral polyneuropathy or comorbidities that may cause peripheral polyneuropathy (e.g., diabetes mellitus). * Presence of metabolic disease. * History of fracture in the hand, wrist, or forearm. * Active pregnancy. * Presence of open wounds on the wrist. * History of uncontrolled systemic disease (endocrinologic, cardiovascular, pulmonary, hematologic, hepatic, renal, active systemic inflammatory disease, and/or malignancy). * History of inflammatory rheumatic or autoimmune disease. * Distal motor latency of the median nerve \> 5.5 ms on electrophysiological evaluation. * Age \< 18 or \> 60 years. * Cognitive or mental incapacity preventing understanding or completion of questionnaires. * Anatomical variations affecting ultrasonographic assessment of the median nerve (e.g., bifid median nerve, persistent median artery). * Anatomical variations affecting electrophysiological measurements (e.g., Martin-Gruber anastomosis). 2. For Healthy İndividual Participants: Participants will be excluded if they meet any of the following criteria: * Age \< 18 or \> 60 years. * Cognitive or mental incapacity preventing understanding or completion of questionnaires. * Presence of any clinical symptoms potentially related to CTS based on established clinical criteria. * Electrophysiological findings consistent with CTS, based on defined diagnostic thresholds.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Istanbul Unıversity, Istanbul Medicine Faculty, Esnaf Hospital

    Istanbul, Fatih, 34093, Turkey (Türkiye)

More trials for these conditions

Other studies related to the condition(s) this trial covers.