Carpal Tunnel SyndromeNCT06657612
Is Ultrasound-Guided Steroid Injection Less Effective in Carpal Tunnel Syndrome Patients with Bifid Median Nerve?
An observational study of Carpal Tunnel Syndrome, run by Beylikduzu State Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Oct 2024to 15 Jan 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with mild to moderate carpal tunnel syndrome
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Beylikdüzü State Hospital
Istanbul, Beylikdüzü, 34147
About this study
Official title: Is Ultrasound-Guided Steroid Injection Less Effective in Carpal Tunnel Syndrome Patients with Bifid Median Nerve?: a Focus on Short-Term Efficacy
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.
Read the detailed description
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.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- No intervention
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Bifid median nerve | Patients (diagnosed with carpal tunnel syndrome) with bifid median nerve Receives: Other: No intervention | |
| Control group | Patients (diagnosed with carpal tunnel syndrome) with normal median nerve Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0 day, 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start25 Oct 2024
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Beylikduzu State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra Sirin, Beylikduzu State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657612
- Sponsor's protocol ID
- BeylikduzuStateH6
- Status last verified
- Jan 2025
- First submitted
- 22 Oct 2024
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Ultrasound-Guided Steroid Injection Less Effective in Carpal Tunnel Syndrome Patients with Bifid Median Nerve?: a Focus on Short-Term Efficacy
- ClinicalTrials.gov ID
- NCT06657612
- Acronym / sponsor ID
- BeylikduzuStateH6
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Beylikduzu State HospitalUniversity, hospital or other
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bifid median nerve | – | Other: No interventionPatients (diagnosed with carpal tunnel syndrome) with bifid median nerve |
| Control group | – | Other: No interventionPatients (diagnosed with carpal tunnel syndrome) with normal median nerve |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with mild to moderate carpal tunnel syndrome
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Bifid median nerve, Control group |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel Syndrome, run by Beylikduzu State Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS): (time frame: 0 day, 4th week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.