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NCT Number: NCT06538779

Sonographic Examination of Median Nerve Variations

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Etlik City Hospital

Ankara, 06170, Turkey (Türkiye)

Location status: Recruiting

Location contact

Yunus B BAYIR, Specialist

CONTACT

[email protected]

0903127970000

About this study

Patients diagnosed with carpal tunnel syndrome electrophysiologically who applied to Etlik City Hospital physical therapy outpatient clinic will be included in the study.There are no sensitive groups.The research period was determined as 1 year.The sample size was done using G Power 3.1.9.4 statistical power analysis program for Windows.Based on the study conducted by Walker FO et al., the number of patients that would provide a significant difference (with a margin of error of 5% Type 1 and 20% Type 2, a study power of 80% and a confidence interval of 95%) was found to be 129 patients in total.Demographic and clinical characteristics of patients who meet the inclusion criteria and fill out the "Informed Consent Forum" will be recorded.General pain of the patients will be evaluated with the Visual Analogue Scale (Global Pain), symptom severity and functional status will be evaluated with the Boston Carpal Tunnel Questionnaire, and hand grip strength measurement will be evaluated with a dynamometer.The patient hand diagram will be marked according to the patient's sensory symptoms.Median nerve cross-sectional area will be measured at the pisiform level with ultrasound, and distal motor latency and sensory nerve conduction velocity will be measured with EMG and recorded.Median nerve stiffness will be evaluated by real-time elastography.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Visual Analog Scale(VAS)

    Time frame: This evaluation will be made and recorded at the beginning

    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.

Secondary outcomes

  1. Boston Carpal Tunnel Questionnaire

    Time frame: This evaluation will be made and recorded at the beginning.

    symptom severity and functional status scale

  2. Dynamometer

    Time frame: This evaluation will be made and recorded at the beginning.

    Hand grip strength measurement test

  3. Ultrasound

    Time frame: This evaluation will be made and recorded at the beginning.

    Median nerve cross-sectional area measurement at the pisiform level.

  4. Real-time elastography.

    Time frame: This evaluation will be made and recorded at the beginning.

    Median nerve stiffness will be evaluated by real-time strain/sheer elastography.

Study contacts

Contact information is provided by the study sponsor or research team.

Ayşegül YAMAN, specialist

CONTACT

05052423917

Yunus Burak BAYIR, specialist

CONTACT

[email protected]

05058083317

Sponsors and collaborators

Lead sponsor

Yunus Burak Bayır

Other Gov

Registry information

Official study title

Sonographic Examination of Median Nerve Variations and Characteristics Observed in Healthy and Carpal Tunnel Syndrome Patients

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 6, 2024
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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