Efficacy of Steroid Injection in Patients With Bifid Median Nerve Diagnosed Carpal Tunnel Syndrome

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorYunus Burak Bayır

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 2 cc:(1 cc betamethasone dipropionate+1cc physiological saline)

    Drug

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Patients with bifid median nerve diagnosed with carpal tunnel syndromeActive comparator 1 intervention
Group B: Patients with anatomical variations without median nerve diagnosed with carpal tunnel syndromeActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
This evaluation will be made and recorded at the baseline, at the 4th and 12th weeks after the procedure.

Secondary outcomes

1

Boston Carpal Tunnel Questionnaire

symptom severity and functional status scale

Time frame
This evaluation will be made and recorded at the baseline, at the 4th and 12th weeks after the procedure.
2

Electromyography

Distal motor latency and sensory nerve conduction velocity

Time frame
This evaluation will be made and recorded at the beginning.
3

Dynamometer

Hand grip strength measurement test

Time frame
This evaluation will be made and recorded at the baseline, at the 4th and 12th weeks after the procedure
4

Ultrasound

Median nerve cross-sectional area measurement at the pisiform level

Time frame
This evaluation will be made and recorded at the beginning.

Other outcomes

Sponsors and contacts

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Yunus Burak Bayır

Lead sponsor

Ankara Etlik City Hospital

Sponsor institution