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Ultrasound-guided Dextrose Injection Versus Dextrose With Methylprednisolone in Carpal Tunnel Syndrome

NCT06045013 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-09-21

No results posted yet for this study

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?

Conditions

  • Carpal Tunnel Syndrome

Interventions

DRUG

5% dextrose injection

Single ultrasound-guided injection of 4 ml 5% dextrose in carpal tunnel via ulnar approach.

DRUG

5% dextrose injections with methylprednisolone acetate 40 mg/ml

Single ultrasound-guided injection of 3 ml 5% dextrose with 1 ml 40 mg/ml methylprednisolone acetate in carpal tunnel via ulnar approach.

Sponsors & Collaborators

  • Clinical Hospital Centre Zagreb

    collaborator OTHER

  • School of Public Health Andrija Štampar

    collaborator UNKNOWN

  • General and Veteran Hospital Croatian Pride Knin

    lead OTHER

Principal Investigators

  • Igor Begović, MD · General and Veteran Hospital "Croatian Pride" Knin, Croatia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-13
Primary Completion
2026-01-01
Completion
2026-08-30
FDA Drug
Yes

Countries

  • Croatia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06045013 on ClinicalTrials.gov