Sonographic Examination of Median Nerve Variations

NCT06538779 | Recruiting

• 1 other identifier: Median nerve variations
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate the prevalence of bifid median nerve in patients diagnosed with carpal tunnel syndrome (CTS) and whether it has a higher prevalence in CTS patients than in asymptomatic individuals, and to evaluate the characteristics of the bifid median nerve found and whether median nerve variations are predisposing factors in the development of CTS.

Conditions

Carpal Tunnel Syndrome

Keywords

bifid median nerve; carpal tunnel syndrome; variations of median nerve; sonography

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale(VAS)

  The VAS used for pain assessment consists of a line drawn in the form of a ruler,and numbers from 0 to 10(with 0 as ''no pain'' and 10 as ''unbearable pain'') were asked to score.

  This evaluation will be made and recorded at the beginning

Secondary Outcomes (4)

• Boston Carpal Tunnel Questionnaire

  This evaluation will be made and recorded at the beginning.

• Dynamometer

  This evaluation will be made and recorded at the beginning.

• Ultrasound

  This evaluation will be made and recorded at the beginning.

• Real-time elastography.

  This evaluation will be made and recorded at the beginning.

Study Arms (2)

normal median nerve in carpal tunnel syndrome

Patients' general pain will be assessed with Visual Analog Scale (Global Pain), symptom severity and functional status will be assessed with Boston Carpal Tunnel Questionnaire, hand grip strength will be measured with dynamometer. Patient hand diagram will be marked according to patient's sensory symptoms. Median nerve cross-sectional area measurement at pisiform level with ultrasound, distal motor latency and sensory nerve conduction velocity with emg will be performed and recorded. Median nerve stiffness will be assessed with real-time elastography.

Diagnostic Test: elastography,usg

median nerve variation in carpal tunnel syndrome

Patients' general pain will be assessed with Visual Analog Scale (Global Pain), symptom severity and functional status will be assessed with Boston Carpal Tunnel Questionnaire, hand grip strength will be measured with dynamometer. Patient hand diagram will be marked according to patient's sensory symptoms. Median nerve cross-sectional area measurement at pisiform level with ultrasound, distal motor latency and sensory nerve conduction velocity with emg will be performed and recorded. Median nerve stiffness will be assessed with real-time elastography.

Diagnostic Test: elastography,usg

Interventions

elastography,usg DIAGNOSTIC_TEST

Patients' general pain will be assessed with Visual Analog Scale (Global Pain), symptom severity and functional status will be assessed with Boston Carpal Tunnel Questionnaire, hand grip strength will be measured with dynamometer. Patient hand diagram will be marked according to patient's sensory symptoms. Median nerve cross-sectional area measurement at pisiform level with ultrasound, distal motor latency and sensory nerve conduction velocity with emg will be performed and recorded. Median nerve stiffness will be assessed with real-time elastography.

median nerve variation in carpal tunnel syndrome; normal median nerve in carpal tunnel syndrome

Eligibility Criteria

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

Study Population

129 patients

You may qualify if:

• Having typical Carpal Tunnel Sydnrome symptoms lasting longer than 3 months
• Carpal tunnel syndrome diagnosed with EMG
• Being a male/female \>18 years of age

You may not qualify if:

• History of polyneuropathy, brachial plexopathy, thoracic outlet syndrome, or surgery in the wrist area
• Presence of inflammatory arthritis, hypothyroidism, pregnancy, rheumatological disorders, diabetes mellitus
• Presence of peripheral vascular disease

Sponsors & Collaborators

• Yunus Burak Bayır: lead

Study Sites (1)

Etlik City Hospital

Ankara, Ankara, 06170, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Bayrak IK, Bayrak AO, Kale M, Turker H, Diren B. Bifid median nerve in patients with carpal tunnel syndrome. J Ultrasound Med. 2008 Aug;27(8):1129-36. doi: 10.7863/jum.2008.27.8.1129.

  PMID: 18645070 BACKGROUND

• Theofilopoulou S, Katouni K, Papadopoulos V, Pappas N, Antonopoulos I, Giavopoulos P, Chrysikos D, Filippou D. Variations of the Median Nerve and Carpal Tunnel Syndrome: a Systematic Review of the Literature. Maedica (Bucur). 2023 Dec;18(4):699-704. doi: 10.26574/maedica.2023.18.4.699.

  PMID: 38348062 BACKGROUND

• Granata G, Caliandro P, Pazzaglia C, Minciotti I, Russo G, Martinoli C, Padua L. Prevalence of bifid median nerve at wrist assessed through ultrasound. Neurol Sci. 2011 Aug;32(4):615-8. doi: 10.1007/s10072-011-0582-8. Epub 2011 Apr 30.

  PMID: 21533564 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

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

Study Officials

• Başak MANSIZ KAPLAN, assoc. prof.

  Ankara Etlik City Hospital

  STUDY CHAIR

• Ebru KARACA UMAY, prof. dr.

  Ankara Etlik City Hospital

  STUDY CHAIR

• Ajda BAL, prof. dr.

  Ankara Etlik City Hospital

  STUDY CHAIR

• Selin ÇELEBİER, assistant dr

  Ankara Etlik Şehir Hastanesi

  STUDY CHAIR

Central Study Contacts

Yunus Burak BAYIR, specialist

CONTACT

05058083317; yunusburakbayir@gmail.com

Ayşegül YAMAN, specialist

CONTACT

05052423917

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Yunus Burak Bayır, Principal İnvestigator

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 6, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)