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RecruitingPhase 3NCT06045013

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

Comparison of the Efficacy Between Ultrasound-guided Dextrose Injection Versus Dextrose With Methylprednisolone Injection in Patients With Carpal Tunnel Syndrome: a Prospective, Randomized Double-blind Clinical Trial.

Sponsor

General and Veteran Hospital Croatian Pride Knin

Enrollment

70 participants

Start Date

Sep 13, 2023

Study Type

INTERVENTIONAL

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria2

  • age between 18 and 80 years,
  • the diagnosis of idiopathic CTS.

Exclusion Criteria11

  • 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.

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Interventions

DRUG5% dextrose injection

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

DRUG5% 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.

Locations(1)

General and Veteran Hospital "Croatian Pride" Knin

Knin, Croatia

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NCT06045013