Effectiveness of Corticosteroid and 5% Dextrose Versus USG-guided Ozone Injections in Patients With Carpal Tunnel Syndrome: Three Blind Randomized Studies
NCT ID: NCT07002892
Last Updated: 2025-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
72 participants
INTERVENTIONAL
2025-01-01
2026-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy of Ozone Therapy and Splint in Carpal Tunnel Syndrome
NCT06649461
Comparison of Injection Techniques in Carpal Tunnel Syndrome
NCT07105540
Corticosteroid And Ozone Injection In Patıents With Carpal Tunnel Syndrome
NCT06237634
Short-Term Effectiveness of Ultrasound-Guided Corticosteroid Hydrodissection
NCT04848324
Ultrasound-Guided 5% Dextrose Injection for Carpal Tunnel Syndrome
NCT06349265
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ozon treatment group
Each patient will receive 2 ml 10 μg/ml ozon perineural injection into the median nerve under US guidance, for 1 session.
Ozon treatment
Each patient will receive 2 ml 10 μg/ml ozon perineural injection into the median nerve under US guidance, for 1 session.
%5 dextrose injection group
Each patient will receive 2 ml 5% dextrose perineural injection into the median nerve under US guidance, for 1 session.
Dextrose 5%
Each patient will receive 2 ml %5 dextrose perineural injection into the median nerve under US guidance, for 1 session.
corticosteroid injection group
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ozon treatment
Each patient will receive 2 ml 10 μg/ml ozon perineural injection into the median nerve under US guidance, for 1 session.
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.
Dextrose 5%
Each patient will receive 2 ml %5 dextrose perineural injection into the median nerve under US guidance, for 1 session.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Yunus Burak Bayır
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Yunus Burak Bayır
Yunus Burak Bayır, Principal İnvestigator ,specialist doctor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
BAŞAK MANSIZ KAPLAN, ASSOC. PROF.
Role: STUDY_CHAIR
Ankara Etlik City Hospital
DAMLA CANKURTARAN, ASSOC. PROF.
Role: STUDY_CHAIR
Ankara Etlik City Hospital
SELİN ÇELEBİER, ASSİSTANT DOCTOR
Role: STUDY_CHAIR
Ankara Etlik City Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ankara Etlik City Hospital
Ankara, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
AYŞEGÜL YAMAN, SPECİALİST
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024/11
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.