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

NCT07002892 | Recruiting

• 1 other identifier: 2024/11
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carpal Tunnel Syndrome Treatment

Keywords

Ozone therapy; corticosteroid injection; %5 dextrose injection; median nerve; carpal tunnel syndrome

Outcome Measures

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.

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

Secondary Outcomes (4)

• Boston Carpal Tunnel Questionnaire

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

• Electromyography

  This evaluation will be made and recorded at the beginning and at 24th weeks

• Dynamometer

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

• Ultrasound

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

Study Arms (3)

ozon treatment group

ACTIVE COMPARATOR

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

Drug: Ozon treatment

%5 dextrose injection group

ACTIVE COMPARATOR

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

Drug: Dextrose 5%

corticosteroid injection group

ACTIVE COMPARATOR

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.

Drug: Steroid treatment

Interventions

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.

ozon treatment group

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.

corticosteroid injection group

Dextrose 5% DRUG

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

Also known as: perineural dextrose injection

%5 dextrose injection group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yunus Burak Bayır: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, 06170, Turkey (Türkiye)

RECRUITING

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• BAŞAK MANSIZ KAPLAN, ASSOC. PROF.

  Ankara Etlik City Hospital

  STUDY CHAIR

• DAMLA CANKURTARAN, ASSOC. PROF.

  Ankara Etlik City Hospital

  STUDY CHAIR

• SELİN ÇELEBİER, ASSİSTANT DOCTOR

  Ankara Etlik City Hospital

  STUDY CHAIR

Central Study Contacts

YUNUS BURAK BAYIR, SPECİALİST

CONTACT

+905058083317; yunusburakbayir@gmail.com

AYŞEGÜL YAMAN, SPECİALİST

CONTACT

05052423917

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: İnvestigator, out comes assessor and participants will be blind to which procedure is performed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Yunus Burak Bayır, Principal İnvestigator ,specialist doctor

Model Details: Our study was designed as a prospective, triple-blind, randomized study. Patients who applied to our hospital's PMR outpatient clinic and were diagnosed with moderate carpal tunnel syndrome by EMG will be included in the study.

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: June 4, 2025
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: June 4, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)