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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yunus Burak Bayır

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 14, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 14, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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