Carpal Tunnel SyndromeNCT06599086
Efficacy of Steroid Injection in Patients With Bifid Median Nerve Diagnosed Carpal Tunnel Syndrome
A study testing 2 cc:(1 cc betamethasone dipropionate+1cc physiological saline) in people with Carpal Tunnel Syndrome, run by Yunus Burak Bayır at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- 2 cc:(1 cc betamethasone dipropionate+1cc physiological saline)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2024to 14 Sep 2025
- Phase
- Interventional
- 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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Etlik City Hospital
Ankara, Ankara, 06170
Yunus B Bayır, Specialist, 0903127970000, yunusburakbayir@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- 2 cc:(1 cc betamethasone dipropionate+1cc physiological saline)
- Keywords
- corticosteroid, injection, bifid median nerve, carpal tunnel syndrome, variation of median nerve
- 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.
2 cc:(1 cc betamethasone dipropionate+1cc physiological saline)Drug
Also called perineural steroid injection
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with bifid median nerve diagnosed with carpal tunnel syndrome | Active comparator | Each patient will receive 2 cc:(1 cc betamethasone dipropionate+1cc saline) perineural injection into the median nerve under US guidance, for 1 session. Receives: Drug: 2 cc:(1 cc betamethasone dipropionate+1cc physiological saline) |
| Patients with anatomical variations without median nerve diagnosed with carpal tunnel syndrome | Active comparator | 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. Receives: Drug: 2 cc:(1 cc betamethasone dipropionate+1cc physiological saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale(VAS)
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.
Measured: This evaluation will be made and recorded at the baseline, at the 4th and 12th weeks after the procedure.
Secondary outcomes (4)
Boston Carpal Tunnel Questionnaire
symptom severity and functional status scale
Measured: This evaluation will be made and recorded at the baseline, at the 4th and 12th weeks after the procedure.
Electromyography
Distal motor latency and sensory nerve conduction velocity
Measured: This evaluation will be made and recorded at the beginning.
Dynamometer
Hand grip strength measurement test
Measured: This evaluation will be made and recorded at the baseline, at the 4th and 12th weeks after the procedure
Ultrasound
Median nerve cross-sectional area measurement at the pisiform level
Measured: This evaluation will be made and recorded at the beginning.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Sep 2024
- Primary completion14 Sep 2025 (estimated)
- Study completion14 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Our study was designed as a prospective, double-blind randomized controlled study.Patients who applied to our hospital's PMR outpatient clinic and with moderate carpal tunnel syndrome by EMG will be included in the study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yunus Burak Bayır
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Yunus Burak Bayır, Ankara Etlik City Hospital
- Investigators
- Ayşegül Yaman, specialist, Study chair, Ankara Etlik City HospitalBaşak Mansız Kaplan, assoc. prof, Study chair, Ankara Etlik City HospitalAslıhan Uzunkulaoğlu, assoc. prof, Study chair, Ankara Etlik City HospitalSelin Çelebier, assistant dr, Study chair, Seli̇n Çelebi̇er
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599086
- Sponsor's protocol ID
- Perineural steroid Injection
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bayrak IK, Bayrak AO, Kale M, Turker H, Diren B. Bifid median nerve in patients with carpal tunnel syndrome. J Ultrasound Med. 2008 Aug;27(8):1129-36. doi: 10.7863/jum.2008.27.8.1129.
PubMed 18645070Theofilopoulou S, Katouni K, Papadopoulos V, Pappas N, Antonopoulos I, Giavopoulos P, Chrysikos D, Filippou D. Variations of the Median Nerve and Carpal Tunnel Syndrome: a Systematic Review of the Literature. Maedica (Bucur). 2023 Dec;18(4):699-704. doi: 10.26574/maedica.2023.18.4.699.
PubMed 38348062Granata G, Caliandro P, Pazzaglia C, Minciotti I, Russo G, Martinoli C, Padua L. Prevalence of bifid median nerve at wrist assessed through ultrasound. Neurol Sci. 2011 Aug;32(4):615-8. doi: 10.1007/s10072-011-0582-8. Epub 2011 Apr 30.
PubMed 21533564
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06599086
- Acronym / sponsor ID
- Perineural steroid Injection
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- corticosteroid, injection, bifid median nerve, carpal tunnel syndrome, variation of median nerve
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yunus Burak BayırOther government
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 14 Sep 2025 (estimated)
- Study completion
- 14 Sep 2025 (estimated)
- First posted
- 19 Sep 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Our study was designed as a prospective, double-blind randomized controlled study.Patients who applied to our hospital's PMR outpatient clinic and with moderate carpal tunnel syndrome by EMG will be included in the study.
| Arm | Type | Receives |
|---|---|---|
| Patients with bifid median nerve diagnosed with carpal tunnel syndrome | Active comparator | Drug: 2 cc:(1 cc betamethasone dipropionate+1cc physiological saline)Each patient will receive 2 cc:(1 cc betamethasone dipropionate+1cc saline) perineural injection into the median nerve under US guidance, for 1 session. |
| Patients with anatomical variations without median nerve diagnosed with carpal tunnel syndrome | Active comparator | 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| 2 cc:(1 cc betamethasone dipropionate+1cc physiological saline)Also: perineural steroid injectionEach 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 | Patients with anatomical variations without median nerve diagnosed with carpal tunnel syndrome, Patients with bifid median nerve diagnosed with carpal tunnel syndrome |
Primary outcome
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.
4 secondary outcomes
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.
Electromyography
Time frame: 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
Ultrasound
Time frame: This evaluation will be made and recorded at the beginning.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Background: PubMed 18645070Bayrak IK, Bayrak AO, Kale M, Turker H, Diren B. Bifid median nerve in patients with carpal tunnel syndrome. J Ultrasound Med. 2008 Aug;27(8):1129-36. doi: 10.7863/jum.2008.27.8.1129.
- Background: PubMed 38348062Theofilopoulou S, Katouni K, Papadopoulos V, Pappas N, Antonopoulos I, Giavopoulos P, Chrysikos D, Filippou D. Variations of the Median Nerve and Carpal Tunnel Syndrome: a Systematic Review of the Literature. Maedica (Bucur). 2023 Dec;18(4):699-704. doi: 10.26574/maedica.2023.18.4.699.
- Background: PubMed 21533564Granata G, Caliandro P, Pazzaglia C, Minciotti I, Russo G, Martinoli C, Padua L. Prevalence of bifid median nerve at wrist assessed through ultrasound. Neurol Sci. 2011 Aug;32(4):615-8. doi: 10.1007/s10072-011-0582-8. Epub 2011 Apr 30.
- 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.
Ayşegül Yaman, specialist study chair
Ankara Etlik City Hospital
Başak Mansız Kaplan, assoc. prof study chair
Ankara Etlik City Hospital
Aslıhan Uzunkulaoğlu, assoc. prof study chair
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2 cc:(1 cc betamethasone dipropionate+1cc physiological saline) in people with Carpal Tunnel Syndrome, run by Yunus Burak Bayır 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 30 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YUNUS BURAK BAYIR, SPECİALİST (05058083317, yunusburakbayir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06599086, which also lists 3 linked publications.
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 30 May 2025.