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.
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Pain intensity at 4 weeks post injection
Study Overview
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?
Detailed Description
The research will be conducted in the General and Veteran Hospital "Croatian Pride" Knin.
The research will be a prospective, randomized, double-blinded, head-to-head comparative study.
The goal of the research is to compare the efficacy of ultrasound-guided 5% dextrose injection versus 5% dextrose with 40 mg methylprednisolone injection in patients with carpal tunnel syndrome (CTS).
Randomization of patients will be performed before the intervention using computer software.
All participants will sign written informed consent and the study will be performed under the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. The study is approved by the Ethical Committee at the General and Veteran Hospital "Croatian Pride" Knin (approval number: 510.01/23-01/79).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
5% dextrose injection
Ultrasound-guided 4 ml single injection of 5% dextrose
Intervention: 5% dextrose injection (Drug)
5% dextrose injections with methylprednisolone acetate
Ultrasound-guided single injection of 3 ml 5% dextrose plus 1 ml 40 mg/ml methylprednisolone acetate
Intervention: 5% dextrose injections with methylprednisolone acetate 40 mg/ml (Drug)
Outcomes
Primary Outcomes
Pain intensity at 4 weeks post injection
Time Frame: before injection, 4 weeks post injection
Assessment of pain intensity using 10 cm Visual Analogue Scale (VAS pain), 0-10; 0=no pain, 10=the most severe pain.
Secondary Outcomes
- Grip strength(before injection, 4, 12 and 24 weeks post injection.)
- Pain intensity at 12 and 24 weeks post injection(before injection,12 and 24 weeks post injection.)
- Symptoms severity and functional impairment of carpal tunnel syndrome (CTS)(before injection, 4, 12 and 24 weeks post injection.)
- Median nerve cross-sectional area (CSA)(before injection, 4, 12 and 24 weeks post injection.)
- Quality of life (QoL)(before injection, 4, 12 and 24 weeks post injection.)
Investigators
Igor Begović
Physical medicine and rehabilitation specialist
General and Veteran Hospital Croatian Pride Knin