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

NCT06933511 | Completed

• 1 other identifier: AESH-BSevingul-02-003
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carpal Tunnel Syndrome (CTS); Diabetic Polyneuropathy; Shear Wave Elastography; Median Nerve; Ultrasound; Hand Function

Keywords

Carpal Tunnel Syndrome; Diabetic Polyneuropathy; Shear wave elastography; Ultrasound; Median nerve; hand function

Outcome Measures

Primary Outcomes (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.

  baseline (single session)

Secondary Outcomes (3)

• Microvascular Imaging (MVI) of the Median Nerve

  baseline (single session)

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

  baseline (single session)

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

  baseline (single session)

Study Arms (6)

(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.

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 40127092 RESULT

• 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.

  PMID: 38516753 RESULT

• 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.

  PMID: 34963555 RESULT

• 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.

  PMID: 31994817 RESULT

• 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.

  PMID: 37716949 RESULT

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Burcu Sevingul, M.D.

  Ankara Etlik City Hospital

  PRINCIPAL INVESTIGATOR

• Burcu Sevingul, M.D.

  Ankara Etlik City Hospital

  STUDY DIRECTOR

• Ebru Karaca Umay, M.D.

  Ankara Etlik City Hospital

  STUDY CHAIR

• Alper Dilli, M.D.

  Ankara Etlik City Hospital

  STUDY CHAIR

• Burcu Kucuk Bicer, M.D.

  Gazi University, Faculty of Medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor (Physical Medicine and Rehabilitation Resident Doctor)

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 18, 2025
• Study Start: April 18, 2025
• Primary Completion: June 27, 2025
• Study Completion: November 25, 2025
• Last Updated: March 27, 2026

Record last verified: 2025-04

Locations

TU (1)