Clinical trial NCT06538779: Sonographic Examination of Median Nerve Variations
Official title: Sonographic Examination of Median Nerve Variations and Characteristics Observed in Healthy and Carpal Tunnel Syndrome Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carpal Tunnel Syndrome
Keywords: bifid median nerve
carpal tunnel syndrome
variations of median nerve
sonography
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-08-06
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 129 patients

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scale(VAS)
timeFrame: This evaluation will be made and recorded at the beginning
Secondary outcomes:
measure: Boston Carpal Tunnel Questionnaire
timeFrame: This evaluation will be made and recorded at the beginning.
measure: Dynamometer
timeFrame: This evaluation will be made and recorded at the beginning.
measure: Ultrasound
timeFrame: This evaluation will be made and recorded at the beginning.
measure: Real-time elastography.
timeFrame: This evaluation will be made and recorded at the beginning.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Etlik City Hospital
Study officials:
affiliation: Ankara Etlik City Hospital
name: Başak MANSIZ KAPLAN, assoc. prof.
role: STUDY_CHAIR
affiliation: Ankara Etlik City Hospital
name: Ebru KARACA UMAY, prof. dr.
role: STUDY_CHAIR
affiliation: Ankara Etlik City Hospital
name: Ajda BAL, prof. dr.
role: STUDY_CHAIR
affiliation: Ankara Etlik Şehir Hastanesi
name: Selin ÇELEBİER, assistant dr
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.