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

Yunus Burak Bayır

Status: Enrolling

Conditions: Carpal Tunnel Syndrome Treatment

Treatments: Drug: Ozon treatment; Drug: Dextrose 5%; Drug: Steroid treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07002892

2024/11

Details and patient eligibility

About

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

Full description

Patients who were diagnosed with moderate CTS by EMG after clinically diagnosing CTS in our hospital's PTR clinic will be included in our study. At the beginning of the study, based on the study conducted by Wu et al. (1) who evaluated the effectiveness of dextrose prolotherapy in the treatment of patients diagnosed with carpal tunnel syndrome, the minimum number of patients required for each group was determined as 20 with a mean pain VAS change of 20%, a significance level of 0.05 and a power analysis of 95%. Considering that there may be a 20% loss during the study, it was decided to include a total of 72 patients, at least 24 patients for each group.

Patients who meet the inclusion criteria and fill out the "Informed Volunteer Consent Form" will be numbered according to their application order to the PTR clinic and will be randomized into three groups of 24 people using the "Research Randomizer" computer program, with the first group being the Ozone Group (OG), the second group being the Dextrose Group (DG) and the third group being the Corticosteroid Group (SG). Initial evaluations of the participants will be made before the injection. Each patient will receive one session of perineural injection of 1 ml betamethasone dipropionate mixed with 1 ml physiological serum to the first group; 2 ml 5% dextrose to the second group; and 2 ml 10 pg/ml ozone to the third group. The solutions to be administered will be prepared by one person in syringes that are taped shut from the outside, and then applied with a 27-gauge needle by a specialist physician who has no role in the evaluation of the results of the randomization section, from the proximal entrance of the carpal tunnel (scaphoid-psiform plane) under ultrasound guidance. In addition, each patient will wear a wrist splint for 8 hours daily during the post-treatment follow-up period. Treatment follow-up evaluations will be evaluated blindly by another specialist physician who has no role in the randomization, outcome evaluation and injection. Pre-treatment Visual Analog Scale (Global Pain), Boston Carpal Tunnel Questionnaire (Symptom Severity Scale and Functional Status Scale), Ultrasound (Measurement of median nerve cross-sectional area at pisiform level), EMG (Distal motor latency and sensory nerve conduction velocity), Hand grip strength measurement test (Dynamometer), VAS, Boston Carpal Tunnel Questionnaire, Ultrasound, Hand grip strength measurement test at the 4th week, VAS, Boston Carpal Tunnel Questionnaire, Ultrasound, Hand grip strength measurement test at the 12th week and VAS, Boston Carpal Tunnel Questionnaire, Ultrasound, Hand grip strength measurement test at the 24th week.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• Not having benefited from splinting and rest

Exclusion criteria

• 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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 3 patient groups

ozon treatment group

Active Comparator group

Description:

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

Treatment:

Drug: Ozon treatment

%5 dextrose injection group

Active Comparator group

Description:

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

Treatment:

Drug: Dextrose 5%

corticosteroid injection group

Active Comparator group

Description:

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

Treatment:

Drug: Steroid treatment