Investigation of the Relationship Between Ultrasonographic Parameters and Tactile Sensation in Carpal Tunnel Syndrome

NCT07170449 | Recruiting

• 1 other identifier: Sultan Abdulhamid Han
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to investigate the relationship between different ultrasonographic indices used in patients with carpal tunnel syndrome and the level of tactile sensation. The primary questions the study aimed to answer are: • To what extent are the ultrasonographic parameters used in the diagnosis of carpal tunnel syndrome related to the level of sensory complaints in the patient?

Conditions

Carpal Tunnel Syndrome (CTS)

Keywords

Carpal Tunnel Syndrome; Ultrasonography; Tactile Sensation

Outcome Measures

Primary Outcomes (9)

• median nerve ultrasound

  Median nerve maximum cross-sectional area measurement at the level of the carpal tunnel (mm²)

  3 Months

• Pointed - blunt discrimination test

  The patient is asked to distinguish between a pointed and a blunt tip by touching the median nerve dermatome.

  3 Months

• Moved two point discrimination

  The patient's finger is touched, starting from the distal tip and moving proximally, and the patient is asked to distinguish between one and two dots. The distance between the last pair of dots the patient can distinguish is noted in mm.

  3 months

• Fixed Two Point Discrimination Test

  The patient's finger is touched starting from the distal tip and working proximally, and the patient is asked to distinguish between one and two dots. The distance between the last pair of dots the patient can distinguish is noted in millimeters.

  3 months

• Semmes Weinstein Test

  With the patient's eyes closed, monofilament is applied perpendicularly in a steady manner until the filament bends. Use a smooth motion to touch the skin with the filament, bend the filament for a full second, than lift from the skin. Patient raises hand to indicate that the monofilament touch sensation is perceived.

  3 months

• median nerve ultrasound

  Median nerve echogenicity at the level of the carpal tunnel (%)

  3 months

• median nerve ultrasound

  Median nerve cross-sectional area measurement at the level of the carpal tunnel inlet (mm²)

  3 months

• median nerve ultrasound

  Median nerve cross-sectional area measurement at the level of the carpal tunnel outlet (mm²)

  3 months

• median nerve ultrasound

  Median nerve cross-sectional area measurement at the level of the pronator quadratus (mm²)

  3 months

Secondary Outcomes (3)

• Boston Carpal Tunnel Syndrome Questionnaire

  3 Months

• S-LANSS

  3 Months

• SF-12 (Short Form-12)

  3 months

Study Arms (1)

Patient group

Patients with carpal tunnel syndrome

Diagnostic Test: Nerve conduction studies; Diagnostic Test: Median nerve ultrasonography; Diagnostic Test: Sensory testing

Interventions

Nerve conduction studies DIAGNOSTIC_TEST

Upper extremity nerve conduction studies including median-ulnar sensory and motor responses

Patient group

Median nerve ultrasonography DIAGNOSTIC_TEST

Median nerve sonographic cross-sectional area and echogenicity measurements

Patient group

Sensory testing DIAGNOSTIC_TEST

tactile sensory tests

Patient group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with diagnosed CTS

You may qualify if:

• Electrodiagnostic diagnosis of carpal tunnel syndrome with pain, numbness, burning, and tingling consistent with the median nerve dermatomal area lasting at least 6 weeks.
• Literate
• Agree to participate in the study

You may not qualify if:

• Concomitant diabetes, systemic inflammatory disease, active infection, and history of malignancy
• Being \<18 and \>65 years old
• Being illiterate
• Refusing to participate in the study
• Having a disease with neuropathic pain, such as polyneuropathy, radiculopathy, or MS
• Other concomitant upper extremity entrapment neuropathies (e.g., cubital tunnel syndrome)
• Having undergone surgery for carpal tunnel syndrome
• Rheumatoid arthritis, advanced hand osteoarthritis

Sponsors & Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: lead

Study Sites (1)

Sultan Abdülhamit Han Trainin and Educational Hospital

Üsküdar, İ̇stanbul, Turkey (Türkiye)

RECRUITING

Related Publications (9)

• Bennett MI, Smith BH, Torrance N, Potter J. The S-LANSS score for identifying pain of predominantly neuropathic origin: validation for use in clinical and postal research. J Pain. 2005 Mar;6(3):149-58. doi: 10.1016/j.jpain.2004.11.007.

  PMID: 15772908 BACKGROUND

• Sezgin M, Incel NA, Serhan S, Camdeviren H, As I, Erdogan C. Assessment of symptom severity and functional status in patients with carpal tunnel syndrome: reliability and functionality of the Turkish version of the Boston Questionnaire. Disabil Rehabil. 2006 Oct 30;28(20):1281-5. doi: 10.1080/09638280600621469.

  PMID: 17083175 BACKGROUND

• Multanen J, Ylinen J, Karjalainen T, Ikonen J, Hakkinen A, Repo JP. Structural validity of the Boston Carpal Tunnel Questionnaire and its short version, the 6-Item CTS symptoms scale: a Rasch analysis one year after surgery. BMC Musculoskelet Disord. 2020 Sep 12;21(1):609. doi: 10.1186/s12891-020-03626-2.

  PMID: 32919457 BACKGROUND

• Stevens JC. AAEE minimonograph #26: The electrodiagnosis of carpal tunnel syndrome. Muscle Nerve. 1987 Feb;10(2):99-113. doi: 10.1002/mus.880100202.

  PMID: 3821791 BACKGROUND

• Fisse AL, Pitarokoili K, Motte J, Gamber D, Kerasnoudis A, Gold R, Yoon MS. Nerve echogenicity and intranerve CSA variability in high-resolution nerve ultrasound (HRUS) in chronic inflammatory demyelinating polyneuropathy (CIDP). J Neurol. 2019 Feb;266(2):468-475. doi: 10.1007/s00415-018-9158-3. Epub 2018 Dec 15.

  PMID: 30554264 BACKGROUND

• Wolny T, Linek P. Reliability of two-point discrimination test in carpal tunnel syndrome patients. Physiother Theory Pract. 2019 Apr;35(4):348-354. doi: 10.1080/09593985.2018.1443358. Epub 2018 Feb 26.

  PMID: 29482409 BACKGROUND

• Kim JM, Kim MW, Ko YJ. Correlating ultrasound findings of carpal tunnel syndrome with nerve conduction studies. Muscle Nerve. 2013 Dec;48(6):905-10. doi: 10.1002/mus.23841. Epub 2013 Sep 11.

  PMID: 23512486 BACKGROUND

• Aboonq MS. Pathophysiology of carpal tunnel syndrome. Neurosciences (Riyadh). 2015 Jan;20(1):4-9.

  PMID: 25630774 BACKGROUND

• Yucel H. Factors affecting symptoms and functionality of patients with carpal tunnel syndrome: a retrospective study. J Phys Ther Sci. 2015 Apr;27(4):1097-101. doi: 10.1589/jpts.27.1097. Epub 2015 Apr 30.

  PMID: 25995565 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Nerve Conduction Studies

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Müyesser Cavlak, PhD

  Sultan Abdülhamit Han Trainin and Educatioal Hospital

  PRINCIPAL INVESTIGATOR

• Emre Ata, Assoc Prof

  Sultan Abdülhamit Han Trainin and Educatioal Hospital

  STUDY CHAIR

Central Study Contacts

Müyesser Cavlak, PhD

CONTACT

+905426406118; muyessercavlak@hotmail.com

Feyza Nur Yücel, Specialist

CONTACT

5385577059 ext +90; dr.fny28@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 12, 2025
• Study Start: August 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 30, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)