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

May 25, 2025 updated by: Yunus Burak Bayır

USG-guided Steroid Injection Treatment: Efficacy of in Patients With Bifid Median Nerve Diagnosed Carpal Tunnel Syndrome Versus With Non-bifid Median Nerve Diagnosed Carpal Tunnel Syndrome:A Single-blind Randomized Controlled Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Ankara, Turkey, 06170
        • Recruiting
        • Etlik City Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: 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.
Other Names:
  • perineural steroid injection
Active Comparator: 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.
Drug: 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.
Other Names:
  • perineural steroid injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale(VAS)
Time Frame: This evaluation will be made and recorded at the baseline, at the 4th and 12th weeks after the procedure.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Boston Carpal Tunnel Questionnaire
Time Frame: This evaluation will be made and recorded at the baseline, at the 4th and 12th weeks after the procedure.
symptom severity and functional status scale
This evaluation will be made and recorded at the baseline, at the 4th and 12th weeks after the procedure.
Electromyography
Time Frame: This evaluation will be made and recorded at the beginning.
Distal motor latency and sensory nerve conduction velocity
This evaluation will be made and recorded at the beginning.
Dynamometer
Time Frame: This evaluation will be made and recorded at the baseline, at the 4th and 12th weeks after the procedure
Hand grip strength measurement test
This evaluation will be made and recorded at the baseline, at the 4th and 12th weeks after the procedure
Ultrasound
Time Frame: This evaluation will be made and recorded at the beginning.
Median nerve cross-sectional area measurement at the pisiform level
This evaluation will be made and recorded at the beginning.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yunus Burak Bayır

Investigators

  • Study Chair: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2024

Primary Completion (Estimated)

September 14, 2025

Study Completion (Estimated)

September 14, 2025

Study Registration Dates

First Submitted

September 10, 2024

First Submitted That Met QC Criteria

September 12, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

May 30, 2025

Last Update Submitted That Met QC Criteria

May 25, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Perineural steroid Injection

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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