Efficacy of Steroid Injection in Patients With Bifid Median Nerve Diagnosed Carpal Tunnel Syndrome

NCT06599086 | Recruiting

• 1 other identifier: Perineural steroid Injection
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Various median nerve anatomical variations have been reported in the literature.One of these is the bifid median nerve.Due to its relatively higher cross-sectional area, it can facilitate compression of the median nerve in the carpal tunnel.Therefore, bifid median nerve is relatively common in patients with CTS.Some studies have shown that the bifid median nerve has an effect on surgical failure in the treatment of carpal tunnel syndrome.Apart from surgical treatment, perineural injection with corticosteroids is a treatment method that has been used for a long time in the treatment of mild and moderate carpal tunnel syndrome.It is controversial whether bifid median nerve has a negative effect on treatment effectiveness.When looking at the literature, there is no previous study on this subject.With the introduction of ultrasound into our daily practice, the frequency of ultrasound-guided perineural injections has increased.Ultrasound allowed us to see variations in the median nerve before injection.The aim of the study is to compare the effectiveness of steroid injection in patients with CTS with bifid median nerve and patients with CTS with non-variant median nerve.It is also to investigate whether this anatomical variation has a negative effect on the treatment.

Conditions

Carpal Tunnel Syndrome

Keywords

corticosteroid; injection; bifid median nerve; carpal tunnel syndrome; variation of median nerve

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale(VAS)

  Global pain:The VAS used for pain assessment consists of a line drawn in the form 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 baseline, at the 4th and 12th weeks after the procedure.

Secondary Outcomes (4)

• Boston Carpal Tunnel Questionnaire

  This evaluation will be made and recorded at the baseline, at the 4th and 12th weeks after the procedure.

• Electromyography

  This evaluation will be made and recorded at the beginning.

• Dynamometer

  This evaluation will be made and recorded at the baseline, at the 4th and 12th weeks after the procedure

• Ultrasound

  This evaluation will be made and recorded at the beginning.

Study Arms (2)

Patients with bifid median nerve diagnosed with carpal tunnel syndrome

ACTIVE COMPARATOR

Each patient will receive 2 cc:(1 cc betamethasone dipropionate+1cc saline) perineural injection into the median nerve under US guidance, for 1 session.

Drug: 2 cc:(1 cc betamethasone dipropionate+1cc physiological saline)

Patients with anatomical variations without median nerve diagnosed with carpal tunnel syndrome

ACTIVE COMPARATOR

Each patient will receive 2 cc:(1 cc betamethasone dipropionate+1cc physiological saline) perineural injection into the median nerve under US guidance, for 1 session.

Drug: 2 cc:(1 cc betamethasone dipropionate+1cc physiological saline)

Interventions

2 cc:(1 cc betamethasone dipropionate+1cc physiological saline) DRUG

Each patient will receive 2 cc:(1 cc betamethasone dipropionate+1cc physiological saline) perineural injection into the median nerve under US guidance, for 1 session.

Also known as: perineural steroid injection

Patients with anatomical variations without median nerve diagnosed with carpal tunnel syndrome; Patients with bifid median nerve diagnosed with carpal tunnel syndrome

Eligibility Criteria

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

You may qualify if:

• Being between the ages of 18-65
• Being clinically diagnosed with Carpal Tunnel Syndrome
• Confirmation of mild and moderate Carpal Tunnel Syndrome diagnosis with EMG
• Diagnosis of bifid median nerve after ultrasound evaluation, No variation was detected for the control group either.
• Having typical Carpal Tunnel Syndrome symptoms for at least 3 months

You may not qualify if:

• History of polyneuropathy, brachial plexopathy, thoracic outlet syndrome, or wrist surgery
• History of Inflammatory arthritis, hypothyroidism, pregnancy,rheumatological disorders or heart battery
• current warfarin use, Prior steroid injection for CTS, trauma or neoplasm at the injection site, hypersensitivity to corticosteroids or skin infection at the injection site
• other median nerve variations and presence of persistent median artery.

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

• Ayşegül Yaman, specialist

  Ankara Etlik City Hospital

  STUDY CHAIR

• Başak Mansız Kaplan, assoc. prof

  Ankara Etlik City Hospital

  STUDY CHAIR

• Aslıhan Uzunkulaoğlu, assoc. prof

  Ankara Etlik City Hospital

  STUDY CHAIR

• Selin Çelebier, assistant dr

  Seli̇n Çelebi̇er

  STUDY CHAIR

Central Study Contacts

YUNUS BURAK BAYIR, SPECİALİST

CONTACT

05058083317; yunusburakbayir@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The physician performing the evaluation and participants will be blind to which procedure is performed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Yunus Burak Bayır, Principal İnvestigator

Model Details: Our study was designed as a prospective, double-blind randomized controlled study.Patients who applied to our hospital's PMR outpatient clinic and with moderate carpal tunnel syndrome by EMG will be included in the study.

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: September 15, 2024
• Primary Completion: September 14, 2025
• Study Completion: September 14, 2025
• Last Updated: May 30, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)