NCT06045013 Ultrasound-guided Dextrose Injection Versus Dextrose With Methylprednisolone in Carpal Tunnel Syndrome
| NCT ID | NCT06045013 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | General and Veteran Hospital Croatian Pride Knin |
| Condition | Carpal Tunnel Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2023-09-13 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 70 participants in total. It began in 2023-09-13 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this prospective, randomized, double-blinded, head-to-head comparative study is to compare the efficacy of ultrasound-guided 4 ml 5% dextrose perineural injection versus 3 ml 5% dextrose with 1 ml 40 mg/ml methylprednisolone perineural injection in patients with carpal tunnel syndrome (CTS). The main questions it aims to answer are: Is there a difference in efficacy between interventions regarding 1. pain alleviation, 2. improvement in symptoms severity and functional status, 3. improvement in grip strength, 4. size of median nerve cross-sectional area, and 5. improvement in quality of life during the six-month post-intervention follow-up period?
Eligibility Criteria
Inclusion Criteria: * age between 18 and 80 years, * the diagnosis of idiopathic CTS. Exclusion Criteria: * contraindications for local application of methylprednisolone or 5% dextrose (hypersensitivity to the drug, infection and skin damage at the application site), * previous wrist surgery, * traumatic wrist injury within 2 years, * previous wrist injection within 6 months, * previous physical therapy within 6 months, * history of peripheral traumatic nerve injury in the upper extremity, brachial plexopathy, severe cervical radiculopathy, and thoracic outlet syndrome, * history of diabetes * history of thyroid disease, * history of inflammatory rheumatic disease, * pregnancy, * inability to cooperate with the study protocol.
Contact & Investigator
Igor Begović, MD
PRINCIPAL INVESTIGATOR
General and Veteran Hospital "Croatian Pride" Knin, Croatia
Frequently Asked Questions
Who can join the NCT06045013 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Carpal Tunnel Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06045013 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 70 participants.
Is NCT06045013 currently recruiting?
Yes, NCT06045013 is actively recruiting participants. Contact the research team at igorbegovic2@gmail.com for enrollment information.
Where is the NCT06045013 trial being conducted?
This trial is being conducted at Knin, Croatia.
Who is sponsoring the NCT06045013 clinical trial?
NCT06045013 is sponsored by General and Veteran Hospital Croatian Pride Knin. The principal investigator is Igor Begović, MD at General and Veteran Hospital "Croatian Pride" Knin, Croatia. The trial plans to enroll 70 participants.