CompletedNot Applicable

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

Turkey (Türkiye)84 participantsStarted 2025-04-18

Plain-language 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. It also compares the individual and combined effects of type 2 diabetes mellitus, DPN, and CTS on symptoms and hand function.

Who can participate

Age range

18 Years – 78 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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: * 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. Exclusion Criteria: * 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. * 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. * Hi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sonographic and symptomatic assessment of median nerve

Timeframe: baseline (single session)

Trial details

NCT IDNCT06933511

SponsorAnkara Etlik City Hospital

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2025-06-27

View on ClinicalTrials.gov More Carpal Tunnel Syndrome (CTS) trials