Is Ultrasound-Guided Steroid Injection Less Effective in Carpal Tunnel Syndrome Patients with Bifid Median Nerve?

NCT06657612 | Completed

• 1 other identifier: BeylikduzuStateH6
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the short-term efficacy of ultrasound-guided corticosteroid injection in patients with and without bifid median nerve.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (4)

• Visual Analog Scale (VAS):

  The Visual Analog Scale is a widely used tool to assess the intensity of pain. It consists of a straight line, typically 10 cm in length, where one end represents "no pain" (0) and the other end represents "worst imaginable pain" (10). Patients mark a point on the line that corresponds to their current level of pain. VAS provides a simple, quantitative measure of pain that is easy for patients to use and for clinicians to interpret, making it a reliable tool for tracking changes in pain levels over time.

  0 day, 4th week

• Boston Carpal Tunnel Syndrome Questionnaire Symptom Severity Scale (BCTQ-SSS):

  The SSS assesses the severity of carpal tunnel symptoms such as pain, tingling, and numbness. The total score for this scale ranges from a minimum of 11 to a maximum of 55. A lower score indicates mild or no symptoms, while a higher score suggests more severe symptoms. As the score increases, the severity of symptoms worsens, with a score closer to 55 reflecting a significantly greater impact on daily life.

  0 day, 4th week

• Quick Disabilities of the Arm, Shoulder, and Hand Questionnaire (Quick-DASH):

  The Quick-DASH is a shortened version of the full DASH questionnaire, designed to measure physical function and symptoms in people with musculoskeletal disorders of the upper limb. It consists of 11 items that assess the difficulty a patient experiences in performing activities of daily living, such as carrying a heavy object, opening a jar, or using a computer. Each item is scored on a 5-point Likert scale, where higher scores reflect greater disability. The Quick-DASH is a validated, efficient tool that provides a broad overview of the patient's upper extremity function and how their condition affects daily life.

  0 day, 4th week

• Boston Carpal Tunnel Syndrome Questionnaire Functional Status Scale (BCTQ-FSS):

  The FSS evaluates how carpal tunnel syndrome affects a person's ability to perform daily tasks like writing, buttoning clothes, or holding objects. The total score for this scale ranges from a minimum of 8 to a maximum of 40. A lower score suggests little to no difficulty in performing these tasks, while a higher score reflects greater functional limitations. As the FSS score increases, it indicates that the condition is having a more pronounced effect on daily functioning.

  0 day, 4th week

Study Arms (2)

Bifid median nerve

Patients (diagnosed with carpal tunnel syndrome) with bifid median nerve

Other: No intervention

Control group

Patients (diagnosed with carpal tunnel syndrome) with normal median nerve

Other: No intervention

Interventions

No intervention OTHER

No intervention

Bifid median nerve; Control group

Eligibility Criteria

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

Study Population

Patients with mild to moderate carpal tunnel syndrome

You may qualify if:

• Patients aged 18-65.
• Diagnosed with mild to moderate carpal tunnel syndrome based on electrophysiological studies conducted within the last 6 months.
• Scheduled for ultrasound-guided corticosteroid injection.
• Patients who have agreed to participate in the study.

You may not qualify if:

• Diagnosis of any other condition that could cause neuropathic symptoms, such as polyneuropathy, brachial plexopathy, or thoracic outlet syndrome.
• Previous history of injection or surgery for carpal tunnel syndrome
• Patients who refuse to participate in the study.

Sponsors & Collaborators

• Beylikduzu State Hospital: lead

Study Sites (1)

Beylikdüzü State Hospital

Istanbul, Beylikdüzü, 34147, Turkey (Türkiye)

Location

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 Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 24, 2024
• Study Start: October 25, 2024
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)