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

NCT ID: NCT06599086

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-15
• Study Completion Date: 2025-09-14

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.

Detailed Description

Our study was designed as a prospective, double-blind randomized controlled study.Patients with an electrophysiological diagnosis of moderate CTS 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.Sample size was calculated using the statistical power analysis programme G Power 3.1.9.4 for windows.Based on the study by Walker FO,the minimum number of patients required to achieve a significant change of 20 mm in VAS assesment before and after treatment(with a 5% Type 1 and Type 2 margin of error, 80% working power and 95% confidence interval) was found to be 17(total 34 patients) for each group.Considering the possibility of 20% loss during the study,ıt was decided to include at least 20(total 40) patients for each group.Demographic and clinical characteristics of Patients who met the inclusion criteria and completed the 'Informed Volunteer Consent Forum' will be recorded.The general pain of the patients will be evaluated with Visual Analog Scala,The symptom severity and functional status of the patients will be evaluated with the Boston Carpal Tunnel Questionnaire,The patients' 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, Distal motor latency and sensory nerve conduction velocity will be recorded with EMG.Pre-injection baseline assessments of participants will be made by a blinded investigator. In all patients, the median nerve will be visualized with ultrasound with a 12 MHz linear probe at the scaphoid-pisiform level.Afterwards, perineural injection(2cc:1cc 2% lidocaine hidroclorid+1cc betamethasone) will be performed using an in-plane approach around the median nerve.

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Patients with bifid median nerve diagnosed with carpal tunnel syndrome

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

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

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: DRUG

Other Intervention Names

perineural steroid injection

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yunus Burak Bayır

OTHER_GOV

Sponsor Role: lead

Responsible Party

Yunus Burak Bayır

Yunus Burak Bayır, Principal İnvestigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ayşegül Yaman, specialist

Role: STUDY_CHAIR

Ankara Etlik City Hospital

Başak Mansız Kaplan, assoc. prof

Role: STUDY_CHAIR

Ankara Etlik City Hospital

Aslıhan Uzunkulaoğlu, assoc. prof

Role: STUDY_CHAIR

Ankara Etlik City Hospital

Selin Çelebier, assistant dr

Role: STUDY_CHAIR

Seli̇n Çelebi̇er

Locations

Etlik City Hospital

Ankara, Ankara, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

YUNUS BURAK BAYIR, SPECİALİST

Role: CONTACT

yunusburakbayir@gmail.com

05058083317

Facility Contacts

Yunus B Bayır, Specialist

Role: primary

yunusburakbayir@gmail.com

0903127970000

References

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.

Reference Type: BACKGROUND

PMID: 18645070 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38348062 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21533564 (View on PubMed)

Other Identifiers

Perineural steroid Injection

Identifier Type: -

Identifier Source: org_study_id