Corticosteroid vs 5% dextrose vs ultrasound-guided ozone injections for carpal tunnel syndrome
Effectiveness of Corticosteroid and 5% Dextrose Versus USG-guided Ozone Injections in Patients With Carpal Tunnel Syndrome: Three Blind Randomized Studies
This study will test whether a corticosteroid shot, a 5% dextrose injection, or an ultrasound-guided ozone injection helps adults with moderate carpal tunnel syndrome reduce pain and improve function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ankara Etlik City Hospital Government |
| Locations | 1 site (Ankara) |
| Trial ID | NCT07002892 on ClinicalTrials.gov |
What this trial studies
This is a randomized, triple-blind, three-arm interventional trial that enrolls adults with moderate carpal tunnel syndrome confirmed by EMG and randomizes them to one of three single perineural injections: betamethasone (with saline), 5% dextrose, or ultrasound-guided ozone. Seventy-two participants (24 per group) are randomized using computer-generated allocation and syringes are prepared and masked by a designated person to maintain blinding. The study is powered to detect a 20% change in pain VAS based on prior dextrose prolotherapy data, with follow-up assessments of pain and clinical function. Standard exclusion criteria remove patients with prior wrist surgery, significant neurologic or systemic disease, pregnancy, anticoagulation with warfarin, or prior corticosteroid injection for CTS.
Who should consider this trial
Good fit: Adults aged 18–65 with clinically and EMG-confirmed moderate carpal tunnel syndrome of at least three months' duration who have not improved with splinting or rest.
Not a fit: People with mild or severe CTS, prior wrist surgery, prior corticosteroid injection for CTS, the listed exclusionary medical conditions (e.g., pregnancy, inflammatory arthritis, current warfarin use), or other neuropathies are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, one of these injection options could provide a more effective non-surgical treatment to reduce pain and improve hand function in people with moderate CTS.
How similar studies have performed: Small prior studies have shown symptom improvement with corticosteroid and dextrose injections, while ozone therapy for CTS is less well studied, so this direct three-way comparison includes both supported and more novel approaches.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ankara
- Ankara Etlik City Hospital — Ankara, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Yunus Burak Bayir, Speci̇ali̇st
- Email: yunusburakbayir@gmail.com
- Phone: +905058083317
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.