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Effectiveness of Corticosteroid and 5% Dextrose Versus USG-guided Ozone Injections in Patients With Carpal Tunnel Syndrome: Three Blind Randomized Studies

ConditionCarpal Tunnel Syndrome Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorYunus Burak Bayır

About this trial

Effectiveness of corticosteroid and 5% dextrose versus USG-guided ozone injections in patients with carpal tunnel syndrome: Three blind randomized studies

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Being between 18-65 years old

Have been clinically diagnosed with carpal tunnel syndrome

Confirmation of moderate CTS diagnosis with EMG

Having typical CTS symptoms for at least 3 months

Disqualifiers

History of polyneuropathy, brachial plexopathy, thoracic outlet syndrome or wrist surgery

History of inflammatory arthritis, hypothyroidism, pregnancy, rheumatologic disorders or pacemaker

Current warfarin use, previous corticosteroid injection for CTS, trauma or neoplasm at the injection site, hypersensitivity to corticosteroids or skin infection(injection site)

G6PD deficiency, hyperthyroidism, thrombocytopenia, severe cardiovascular instability and those receiving ACE inhibitors

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ozon treatment

    Drug

    Each patient will receive 2 ml 10 μg/ml ozon perineural injection into the median nerve under US guidance, for 1 session.

  • Steroid treatment

    Drug

    Each patient will receive 2 ml:(1 ml betamethasone dipropionate+1ml saline) perineural injection into the median nerve under US guidance, for 1 session.

  • Dextrose 5%

    Drug

    Each patient will receive 2 ml %5 dextrose perineural injection into the median nerve under US guidance, for 1 session.

Treatment groups

72 Participants
are divided into 3 treatment groups
Group A: ozon treatment groupActive comparator 1 intervention
Group B: %5 dextrose injection groupActive comparator 1 intervention
Group C: corticosteroid injection groupActive 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, 12th and 24th 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, 12th and 24th 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 and at 24th weeks
3

Dynamometer

Hand grip strength measurement test

Time frame
This evaluation will be made and recorded at the baseline, at the 4th, 12th and 24th 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 baseline, at the 4th, 12th and 24th weeks after the procedure.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yunus Burak Bayır

Lead sponsor

Ankara Etlik City Hospital

Sponsor institution

Source ClinicalTrials.gov
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