Skip to main content
OpenTrials
Completed

NCT Number: NCT06657612

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beylikdüzü State Hospital

Istanbul, Beylikdüzü, 34147, Turkey (Türkiye)

About this study

Twenty-five patients with bifid median nerve and twenty-five patients without bifid median nerve, aged 18-65, who applied to the Physical Therapy and Rehabilitation outpatient clinic at Beylikdüzü State Hospital, diagnosed with mild to moderate carpal tunnel syndrome based on electrophysiological studies, and who received ultrasound-guided corticosteroid injection, will be included in our study. Patients identified as having a bifid median nerve during the injection will be noted and invited for a follow-up at the 1st month to assess their pain and functional status. The same follow-up visit will be conducted for an equal number of age- and gender-matched patients without bifid median nerve who received the injection. At the end of the study, the 1-month efficacy of the injection in both groups will be evaluated. Patients who agree to participate in the study will be asked to complete the Visual Analog Scale (VAS), the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), and the Quick Disabilities of the Arm, Shoulder, and Hand Questionnaire (Quick-DASH) before the injection. They will then be invited for a follow-up visit at the 1st month, where the VAS, BCTQ, and Quick-DASH will be administered again.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Visual Analog Scale (VAS):

    Time frame: 0 day, 4th week

    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.

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

    Time frame: 0 day, 4th week

    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.

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

    Time frame: 0 day, 4th week

    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.

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

    Time frame: 0 day, 4th week

    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.

Sponsors and collaborators

Lead sponsor

Beylikduzu State Hospital

Other

Registry information

Official study title

Is Ultrasound-Guided Steroid Injection Less Effective in Carpal Tunnel Syndrome Patients with Bifid Median Nerve?: a Focus on Short-Term Efficacy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 24, 2024
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.