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Carpal Tunnel Syndrome (CTS)NCT06933511

Impact of Diabetic Polyneuropathy on Carpal Tunnel Syndrome: Shear Wave Elastography, Ultrasound, and Hand Function

An observational study of Carpal Tunnel Syndrome (CTS) and Diabetic Polyneuropathy, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This observational study examines changes in the median nerve in patients diagnosed with diabetic polyneuropathy (DPN) and carpal tunnel syndrome (CTS) using shear wave elastography, microvascular imaging, and cross-sectional area measurements. Read more about this study

Who is it for?
Ages 18 to 78 yearsHealthy volunteers can take part
How many people
84 participants
Where
1 siteTurkey (Türkiye)
Study dates
18 Apr 2025to 25 Nov 2025
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 78 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The study population will include non-diabetic individuals, diabetic individuals with diabetic polyneuropathy (DPN), and diabetic individuals without diabetic polyneuropathy. Participants will be selected based on clinical presentation of hand symptoms such as pain, numbness, tingling, burning, and weakness, and each participant will be assessed for the presence or absence of carpal tunnel syndrome (CTS). Participants from both the diabetic and non-diabetic populations will be included in the study, with both CTS and non-CTS subgroups in each population.

Who may be able to join

  • Patient Group:
  • Presence of carpal tunnel syndrome (CTS) symptoms, including pain, numbness, tingling, burning, and weakness, which worsen during sleep, prolonged hand positions, or repetitive wrist movements, and improve with hand shaking or changing position.
  • Cognitively able to understand and participate in the study.
  • Aged between 18 and 78 years.
  • Has given written informed consent to participate.
  • Control Group:
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  • Asymptomatic individuals, with or without diabetes.
  • Cognitively able to understand and participate in the study.
  • Aged between 18 and 78 years.
  • Has given written informed consent to participate.

Who cannot join

  • History of previous carpal tunnel surgery or injection.
  • History of previous upper extremity trauma.
  • Presence of mass lesions or any condition that compresses the median nerve, observed during ultrasonographic examination.
  • Presence of a persistent median artery.
  • Presence of a bifid or trifid median nerve.
  • Presence of anastomoses, such as Martin-Gruber.
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  • History of long-term excessive alcohol consumption.
  • Chronic renal failure.
  • Presence of neuropathy due to a neurological condition.
  • Thyroid disorders.
  • History of malignancy.
  • History of neurotoxic drug use.
  • Peripheral arterial occlusive disease.
  • Severe diabetic polyneuropathy (DPN) diagnosis.
  • Pregnancy.
  • Cervical radiculopathy or brachial plexopathy.
  • Osteoarthritis of the hand.
  • Rheumatologic disease.
  • Systemic autoimmune disease.
  • History of cerebrovascular disease.
  • Dupuytren's contracture.
  • Sclerodactyly.
  • Cognitive limitations that would prevent understanding the study protocol.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara Etlik City Hospital

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: The Impact of Diabetic Polyneuropathy on Shear Wave Elastography, Ultrasonographic Findings, and Hand Function in Carpal Tunnel Syndrome

This observational study examines changes in the median nerve in patients diagnosed with diabetic polyneuropathy (DPN) and carpal tunnel syndrome (CTS) using shear wave elastography, microvascular imaging, and cross-sectional area measurements. It also compares the individual and combined effects of type 2 diabetes mellitus, DPN, and CTS on symptoms and hand function.

Read the detailed description

After giving written consent, all participants will undergo a screening process to determine if they meet the eligibility criteria for the study. Those who qualify will proceed to the assessment phase.

In the physical examination, participants will undergo several tests on both hands, including Tinel's sign, Phalen's test, joint position sense, two-point discrimination (using a Baseline aesthesiometer), sensory assessment of light touch, hand grip strength (measured with a Baseline hand dynamometer), precision grips (tip-to-tip, lateral, and three-finger grip using a pinch meter), and fine manual dexterity (assessed using the Nine-Hole Peg Test). The distribution of symptoms will be evaluated using the Katz Hand Diagram. Symptom severity will be assessed with the Visual Analog Scale (VAS), the Boston Carpal Tunnel Questionnaire (BCTQ), and the Toronto Clinical Scoring System (TCSS). Disability in the upper extremity will be measured with the Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH) questionnaire.

All participants will undergo ultrasound examination of the median nerve, including cross-sectional area (CSA) measurements and shear wave elastography (SWE) at the wrist (pisiform-scaphoid bone landmarks) and 12 cm proximal to the wrist. We will perform microvascular imaging (MVI) grading at the wrist. We will use the General Electric (GE) LOGIQ Fortis ultrasound device to measure CSA, MVI, and SWE. We will use two different transducers based on the measurement type: the L6-24 'hockey stick' transducer (22 MHz) for CSA and MVI, and the L2-9 linear transducer (14-8 MHz) for SWE assessments.

Following the ultrasound, participants will undergo electrodiagnostic evaluations on all four limbs, which will include sensory and motor conduction studies. Sensory conduction studies will include median nerve stimulation at the wrist with recordings taken from the second digit, and ulnar nerve stimulation at the wrist with recordings from the fifth digit. Additionally, the sensory distal latency difference between the median and ulnar nerves will be assessed by recording from the fourth digit. Motor conduction studies will involve median nerve stimulation at the wrist and antecubital fossa, with recordings from the abductor pollicis brevis muscle. Ulnar nerve conduction will be assessed by stimulating at the wrist, above and below the elbow, with recordings from the abductor digiti minimi. For the lower extremities, the peroneal nerve will be stimulated at the anterior ankle, below the fibular neck, and at the lateral popliteal fossa, with recordings taken from the extensor digitorum brevis. The tibial nerve will be stimulated at the posterior medial malleolus and popliteal fossa, with recordings from the abductor hallucis. The sural sensory conduction study will be performed by stimulating between the heads of the gastrocnemius muscle and recording from the posterior lateral malleolus. In addition, F-wave latency and sympathetic skin response will be measured for the early detection of diabetic polyneuropathy (DPN). In our laboratory, electrodiagnostic evaluations are routinely performed in accordance with the polyneuropathy protocol defined by Shin J. Oh. This protocol includes motor and sensory nerve conduction studies of the median nerve (motor: wrist to elbow; sensory: finger to wrist) in one upper extremity, as well as bilateral motor conduction studies of the posterior tibial and peroneal nerves, and bilateral sensory conduction studies of the sural nerves in the lower extremities. Polyneuropathy is defined as the presence of conduction slowing, reduced amplitude of the action potential, or absence of an evoked response in at least two nerves. Patients who meet this definition and also fulfill the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) simplified criteria will be included in the study. According to the AANEM simplified criteria, a diagnosis of distal symmetric polyneuropathy can be made when abnormalities are detected in at least two nerves-one of which must be the sural nerve-across motor and/or sensory nerve conduction studies performed on a minimum of three limbs, including at least one lower extremity. Based on the electrophysiological classification of carpal tunnel syndrome (CTS) by Padua et al., patients with mild or moderate CTS will be included in the study. Mild CTS is characterized by a slowing of sensory conduction velocity in the median nerve, while distal motor latency remains within normal limits. Moderate CTS is defined by a slowing of median sensory conduction in the second digit-wrist segment, accompanied by an abnormal distal motor latency.

Data will be analyzed on a hand-by-hand basis. Based on G*Power analysis, each group will include at least nine hands. Hands will be categorized into six groups according to electrodiagnostic findings as follows: 1) No diabetes, no DPN, no CTS (DM- / DPN- / CTS-); 2) No diabetes, no DPN, with CTS (DM- / DPN- / CTS+); 3) With diabetes, no DPN, no CTS (DM+ / DPN- / CTS-); 4) With diabetes, no DPN, with CTS (DM+ / DPN- / CTS+); 5) With diabetes, with DPN, no CTS (DM+ / DPN+ / CTS-); and 6) With diabetes, with DPN, with CTS (DM+ / DPN+ / CTS+). These six groups will be compared in terms of ultrasound findings, symptoms, and hand function. The hypothesis being tested is based on the "double crush theory," which suggests that DPN may increase the susceptibility of the median nerve to entrapment, potentially making CTS more likely, and CTS may present as an early sign of DPN. The study will assess the combined effects of DPN and CTS on symptoms and hand function. We will also investigate how the presence of DPN, in addition to CTS, affects symptoms and hand function.

Our secondary objective is to investigate the effects of CTS on the median nerve in the population with DPN, by assessing CSA, MVI, SWE, symptoms, and hand function.

Keywords
Carpal Tunnel Syndrome, Diabetic Polyneuropathy, Shear wave elastography, Ultrasound, Median nerve, hand function
Medical subject headings
Carpal Tunnel Syndrome, Diabetic Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06933511
Study groupRoleWhat they receive
(DM- / DPN- / CTS-)This group will serve as the control for the non-diabetic (DM-) patients with CTS and will be used to observe the effects of CTS alone. Additionally, it will serve as the control for the diabetic (DM+) patients without CTS and will be used to evaluate the effects of diabetes alone on the median nerve. In these patients, diagnoses of DPN and CTS will be excluded through electrodiagnostic testing.
(DM- / DPN- / CTS+)The non-diabetic group with carpal tunnel syndrome (CTS) includes patients diagnosed with mild to moderate CTS through nerve conduction studies.
(DM+ / DPN- / CTS-)The control group consists of diabetic (DM+) patients who have been excluded from diagnoses of diabetic polyneuropathy (DPN) and carpal tunnel syndrome (CTS) based on electrodiagnostic tests.
(DM+ / DPN- / CTS+)The diabetic group with carpal tunnel syndrome (CTS) but without diabetic polyneuropathy (DPN) includes patients who were diagnosed with mild to moderate CTS and excluded from having DPN, both based on nerve conduction studies.
(DM+ / DPN+ / CTS-)The diabetic group with diabetic polyneuropathy (DPN) but without carpal tunnel syndrome (CTS) includes patients who were diagnosed with DPN and excluded from having CTS, both based on nerve conduction studies.
(DM+ / DPN+ / CTS+)The diabetic group with carpal tunnel syndrome (CTS) and diabetic polyneuropathy (DPN) includes patients diagnosed with mild to moderate CTS and DPN, both based on nerve conduction studies.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sonographic and symptomatic assessment of median nerve

    This study investigates how diabetic polyneuropathy (DPN) affects the development and clinical signs of carpal tunnel syndrome (CTS). We will assess the median nerve by measuring its cross-sectional area (CSA), stiffness using shear wave elastography (SWE), and symptom severity with the Boston Carpal Tunnel Questionnaire (BCTQ). The BCTQ is a self-reported questionnaire with 11 items for symptom severity and 8 for functional impairment, each scored from 1 to 5. Higher scores reflect worse symptoms or greater disability. CSA will be measured three times within the median nerve's epineurium-both at the carpal tunnel entrance and on the forearm. SWE will also be measured at these locations, using three circular regions of interest (2-4 mm) selected from the most reliable areas shown on the reliability index map.

    Measured: baseline (single session)

Secondary outcomes (3)
  1. Microvascular Imaging (MVI) of the Median Nerve

    To detect vascular changes in the median nerve associated with CTS and DPN using Doppler ultrasonography. Microvascular Imaging (MVI) was used instead of power Doppler ultrasound due to its superior ability to visualize small-diameter vessels and low blood flow. Microvascularity was graded into four categories: Grade 0 indicates no detectable blood flow; Grade 1 indicates 1-2 isolated flow signals; Grade 2 represents more than two flow points or 1-2 flow strips longer than 1 mm; and Grade 3 denotes more than three continuous flow strips.

    Measured: baseline (single session)

  2. Polyneuropathy Symptom Severity Using the Toronto Clinical Scoring System (TCSS)

    The Toronto Clinical Scoring System (TCSS) is a comprehensive assessment tool divided into three sections. The first section evaluates the presence of symptoms in both the upper and lower extremities, including pain, numbness, tingling, burning, weakness, and instability. A score of 1 is given for each symptom present and 0 for those absent. The second section evaluates reflexes by assessing patellar and Achilles reflexes on both sides. Reflexes are scored as 0 for normal, 1 for reduced, and 2 for absent. The third section involves sensory testing of the great toe, including pinprick, light touch, vibration, thermal sensation, and joint position sense, scoring 0 for normal and 1 for abnormal sensation. The TCSS provides a way to assess the severity of diabetic polyneuropathy and is also useful for monitoring disease progression or response to treatment.

    Measured: baseline (single session)

  3. Hand Function Evaluation with Grip Strength, Nine-Hole Peg Tests and Q-DASH Questionnaire

    The Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH) questionnaire is a self-reported tool that assesses the impact of upper extremity disorders on daily activities, including symptoms and physical limitations. It consists of 11 items, with higher scores indicating greater disability and impairment in hand function. We will measure hand grip strength and test three types of precise grip strength: lateral pinch (similar to holding a key), tip-to-tip pinch (similar to holding a needle), and three-finger pinch (similar to holding a pen). For each type of grip, the average score will be recorded after one-minute intervals. The Nine-Hole Peg Test (NHPT) assesses fine motor skills, manual dexterity, and hand function, providing objective data on the speed and accuracy of hand movements, including for conditions such as carpal tunnel syndrome (CTS).

    Measured: baseline (single session)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2025
  2. Study start18 Apr 2025
  3. Primary completion27 Jun 2025
  4. Study completion25 Nov 2025

Resources

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
Prospective
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06933511
Sponsor's protocol ID
AESH-BSevingul-02-003
Status last verified
Apr 2025
First submitted
11 Apr 2025
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kim J, Kim MW, Kim JM. Enhanced diagnosis and severity assessment of carpal tunnel syndrome using combined shear wave elastography and cross-sectional area analysis: A prospective case-control study. PLoS One. 2025 Mar 24;20(3):e0320011. doi: 10.1371/journal.pone.0320011. eCollection 2025.

    PubMed 40127092
  • Martikkala L, Pemmari A, Himanen SL, Makela K. Median Nerve Shear Wave Elastography Is Associated With the Neurophysiological Severity of Carpal Tunnel Syndrome. J Ultrasound Med. 2024 Jul;43(7):1253-1263. doi: 10.1002/jum.16450. Epub 2024 Mar 22.

    PubMed 38516753
  • Sung JH, Kwon YJ, Baek SH, Son MH, Lee JH, Kim BJ. Utility of shear wave elastography and high-definition color for diagnosing carpal tunnel syndrome. Clin Neurophysiol. 2022 Mar;135:179-187. doi: 10.1016/j.clinph.2021.10.020. Epub 2021 Dec 10.

    PubMed 34963555
  • Wee TC, Simon NG. Shearwave Elastography in the Differentiation of Carpal Tunnel Syndrome Severity. PM R. 2020 Nov;12(11):1134-1139. doi: 10.1002/pmrj.12334. Epub 2020 Feb 14.

    PubMed 31994817
  • Park D, Lee SE, Cho JM, Yang JW, Kim M, Kwon HD. Characteristics of diabetic and non-diabetic carpal tunnel syndrome in terms of clinical, electrophysiological, and Sonographic features: a cross-sectional study. BMC Musculoskelet Disord. 2023 Sep 16;24(1):739. doi: 10.1186/s12891-023-06881-1.

    PubMed 37716949

Questions about this trial

What is this clinical trial studying?

An observational study of Carpal Tunnel Syndrome (CTS) and Diabetic Polyneuropathy, run by Ankara Etlik City 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 10 inclusion and 23 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 27 Mar 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?

Sonographic and symptomatic assessment of median nerve (time frame: baseline (single session)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06933511, which also lists 5 linked publications.

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 27 Mar 2026.

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