Carpal Tunnel Syndrome TreatmentNCT07002892
Effectiveness of Corticosteroid and 5% Dextrose Versus USG-guided Ozone Injections in Patients With Carpal Tunnel Syndrome: Three Blind Randomized Studies
A study testing Ozon treatment, Steroid treatment and Dextrose 5% in people with Carpal Tunnel Syndrome Treatment, run by Yunus Burak Bayır at 1 site in Turkey (Türkiye).
Trial summary
Effectiveness of corticosteroid and 5% dextrose versus USG-guided ozone injections in patients with carpal tunnel syndrome: Three blind randomized studies Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome Treatment
- What is being tested?
- Ozon treatment, Steroid treatment and Dextrose 5%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
AYŞEGÜL YAMAN, SPECİALİST contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Etlik City Hospital
Ankara, 06170
YUNUS BURAK BAYIR, SPECİALİST, +905058083317, yunusburakbayir@gmail.com
YUNUS BURAK BAYIR, SPECİALİST, 05058083317, yunusburakbayir@gmail.com
About this study
Effectiveness of corticosteroid and 5% dextrose versus USG-guided ozone injections in patients with carpal tunnel syndrome: Three blind randomized studies
Read the 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.
- Conditions
- Carpal Tunnel Syndrome Treatment
- Being tested
- Ozon treatment, Steroid treatment, Dextrose 5%
- Keywords
- Ozone therapy, corticosteroid injection, %5 dextrose injection, median nerve, carpal tunnel syndrome
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozon treatmentDrug
Each patient will receive 2 ml 10 μg/ml ozon perineural injection into the median nerve under US guidance, for 1 session.
Steroid treatmentDrug
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
Also called perineural dextrose injection
Each patient will receive 2 ml %5 dextrose perineural injection into the median nerve under US guidance, for 1 session.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Steroid treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
symptom severity and functional status scale
Measured: This evaluation will be made and recorded at the baseline, at the 4th, 12th and 24th weeks after the procedure.
Electromyography
Distal motor latency and sensory nerve conduction velocity
Measured: This evaluation will be made and recorded at the beginning and at 24th weeks
Dynamometer
Hand grip strength measurement test
Measured: This evaluation will be made and recorded at the baseline, at the 4th, 12th and 24th weeks after the procedure.
Ultrasound
Median nerve cross-sectional area measurement at the pisiform level
Measured: This evaluation will be made and recorded at the baseline, at the 4th, 12th and 24th weeks after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start1 Jan 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel Syndrome TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yunus Burak Bayır
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Yunus Burak Bayır, Ankara Etlik City Hospital
- Investigators
- BAŞAK MANSIZ KAPLAN, ASSOC. PROF., Study chair, Ankara Etlik City HospitalDAMLA CANKURTARAN, ASSOC. PROF., Study chair, Ankara Etlik City HospitalSELİN ÇELEBİER, ASSİSTANT DOCTOR, Study chair, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07002892
- Sponsor's protocol ID
- 2024/11
- Status last verified
- Nov 2024
- First submitted
- 25 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32732745Elawamy 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.
PubMed 34213870Bahrami 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.
PubMed 31123423Babaei-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.
PubMed 35848821Nasiri 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.
PubMed 36617808Wu 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.
PubMed 30187524
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Corticosteroid and 5% Dextrose Versus USG-guided Ozone Injections in Patients With Carpal Tunnel Syndrome: Three Blind Randomized Studies
- ClinicalTrials.gov ID
- NCT07002892
- Acronym / sponsor ID
- 2024/11
- Conditions
- Carpal Tunnel Syndrome Treatment
- Keywords
- Ozone therapy, corticosteroid injection, %5 dextrose injection, median nerve, carpal tunnel syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Yunus Burak BayırOther government
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| ozon treatment group | Active comparator | Drug: Ozon treatmentEach 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 | Active comparator | Drug: 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 | Active comparator | Drug: Steroid treatmentEach patient will receive 2 ml:(1 ml betamethasone dipropionate+1 ml saline) perineural injection into the median nerve under US guidance, for 1 session. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ozon treatmentEach patient will receive 2 ml 10 μg/ml ozon perineural injection into the median nerve under US guidance, for 1 session. | Drug | ozon treatment group |
| Steroid treatmentEach patient will receive 2 ml:(1 ml betamethasone dipropionate+1ml saline) perineural injection into the median nerve under US guidance, for 1 session. | Drug | corticosteroid injection group |
| Dextrose 5%Also: perineural dextrose injectionEach patient will receive 2 ml %5 dextrose perineural injection into the median nerve under US guidance, for 1 session. | Drug | %5 dextrose injection group |
Primary outcome
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.
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.
4 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Background: PubMed 32732745Forogh 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.
- Background: PubMed 34213870Elawamy 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.
- Background: PubMed 31123423Bahrami 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.
- Background: PubMed 35848821Babaei-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.
- Background: PubMed 36617808Nasiri 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.
- Background: PubMed 30187524Wu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AYŞEGÜL YAMAN, SPECİALİST contact
BAŞAK MANSIZ KAPLAN, ASSOC. PROF. study chair
Ankara Etlik City Hospital
DAMLA CANKURTARAN, ASSOC. PROF. study chair
Ankara Etlik City Hospital
SELİN ÇELEBİER, ASSİSTANT DOCTOR study chair
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ozon treatment, Steroid treatment and Dextrose 5% in people with Carpal Tunnel Syndrome Treatment, run by Yunus Burak Bayır at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YUNUS BURAK BAYIR, SPECİALİST (+905058083317, yunusburakbayir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07002892, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.