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

Overview

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

Detailed 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.

Interventions

• Drug Ozon treatment
  Each patient will receive 2 ml 10 μg/ml ozon perineural injection into the median nerve under US guidance, for 1 session.
• Drug Steroid treatment
  Each patient will receive 2 ml:(1 ml betamethasone dipropionate+1ml saline) perineural injection into the median nerve under US guidance, for 1 session.
• Drug Dextrose 5%
  Each patient will receive 2 ml %5 dextrose perineural injection into the median nerve under US guidance, for 1 session.

Primary outcome measures

• Visual Analog Scale(VAS) [Time frame: This evaluation will be made and recorded at the baseline, at the 4th, 12th and 24th weeks after the procedure.]

Secondary outcome measures (4)

• Boston Carpal Tunnel Questionnaire [Time frame: This evaluation will be made and recorded at the baseline, at the 4th, 12th and 24th weeks after the procedure.]
• Electromyography [Time frame: This evaluation will be made and recorded at the beginning and at 24th weeks]
• Dynamometer [Time frame: This evaluation will be made and recorded at the baseline, at the 4th, 12th and 24th weeks after the procedure.]
• Ultrasound [Time frame: This evaluation will be made and recorded at the baseline, at the 4th, 12th and 24th weeks after the procedure.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Ankara Etlik City Hospital — Ankara

Publications

• Forogh B, Mohamadi H, Fadavi HR, Madani SP, Aflakian N, Ghazaie F, Babaei-Ghazani A. Comparison of Ultrasound-Guided Local Ozone (O2-O3) Injection Versus Corticosteroid Injection in Patients With Mild to Moderate Carpal Tunnel Syndrome. Am J Phys Med Rehabil. 2021 Feb 1;100(2):168-172. doi: 10.1097/PHM.0000000000001546. PMID 32732745
• Elawamy A, Hassanien M, Talaat EA, Ali AM, Roushdy ASI, Kamel EZ. Intra-Carpal Injection of Ozone versus Methylprednisolone in Carpal Tunnel Syndrome of Systemic Sclerosis Patients: A Randomized Single-Blind Clinical Trial. Pain Physician. 2021 Jul;24(4):E453-E458. PMID 34213870
• Bahrami MH, Raeissadat SA, Nezamabadi M, Hojjati F, Rahimi-Dehgolan S. Interesting effectiveness of ozone injection for carpal tunnel syndrome treatment: a randomized controlled trial. Orthop Res Rev. 2019 May 6;11:61-67. doi: 10.2147/ORR.S202780. eCollection 2019. PMID 31123423
• Babaei-Ghazani A, Moradnia S, Azar M, Forogh B, Ahadi T, Chaibakhsh S, Khodabandeh M, Eftekharsadat B. Ultrasound-guided 5% dextrose prolotherapy versus corticosteroid injection in carpal tunnel syndrome: a randomized, controlled clinical trial. Pain Manag. 2022 Sep;12(6):687-697. doi: 10.2217/pmt-2022-0018. Epub 2022 Jul 18. PMID 35848821
• Nasiri A, Rezaei Motlagh F, Vafaei MA. Efficacy comparison between ultrasound-guided injections of 5% dextrose with corticosteroids in carpal tunnel syndrome patients. Neurol Res. 2023 Jun;45(6):554-563. doi: 10.1080/01616412.2022.2164453. Epub 2023 Jan 8. PMID 36617808
• Wu YT, Ke MJ, Ho TY, Li TY, Shen YP, Chen LC. Randomized double-blinded clinical trial of 5% dextrose versus triamcinolone injection for carpal tunnel syndrome patients. Ann Neurol. 2018 Oct;84(4):601-610. doi: 10.1002/ana.25332. Epub 2018 Oct 4. PMID 30187524

Identifiers

NCT: NCT07002892 · 2024/11

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗