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

September 13, 2023 updated by: Igor Begović, General and Veteran Hospital Croatian Pride Knin

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.

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Adult participants aged between 18 and 80 years with a clinical and electrophysiological diagnosis of idiopathic CTS referred to the Physical Medicine and Rehabilitation clinic will be randomly assigned into two groups using a random number generating software in a 1:1 manner.

Since patients can have CTS in one or both hands, randomization will be conducted according to the patient, thus the same patient can receive the intervention only on one side which will be considered worst.

The minimum sample size of a total of 70 participants (35 in each group) was estimated by analyzing the power of the t-test for independent samples according to the following characteristics: type one error (α=0.05), power (1-ß=0.80), and effect size (d=0.68).

The power analysis of the test was performed using the computer program G*Power for Windows, version 3.1.3.

IBM SPSS Statistics version 29.0 software will be used for the data analysis.

Group one will receive an ultrasound-guided 4 ml single perineural injection of 5% dextrose in the carpal tunnel and group two ultrasound-guided single perineural injection of 3 ml 5% dextrose plus 1 ml 40 mg/ml methylprednisolone acetate in the carpal tunnel.

Participants, the physician who will perform the injection procedure and the assessor will be blinded for the treatment allocation. The only person who will know which intervention drug it is about will be the nurse who will prepare the medicine according to the randomization.

Clinical diagnosis of CTS will be made in the presence of at least one symptom (1. pain, 2. pricking, 3. tingling, 4. burning, or 5. numbness in the innervation area of the median nerve on the hand) and at least one sign (1. objective disturbance of the sense of touch, i.e. hypoesthesia or dysesthesia in the innervation area of the median nerve on the hand, 2. positive Tinel's sign, 3. positive Phalen's sign, or 4. positive compression test).

Inclusion criteria are age between 18 and 80 years and the diagnosis of idiopathic CTS based on clinical and electrophysiological criteria.

Exclusion criteria are 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 traumatic peripheral 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 and inability to cooperate with the study protocol.

Basic demographic data will be obtained: gender, age, Body Mass Index (BMI), level of education, occupation, rating of hand activity and force level applied on the hand during the day, cigarette smoking, hand dominance, affected hand, symptom duration, and history of comorbid conditions.

Pain intensity (using a 10 cm Visual Analogue Scale; VAS pain, 0-10; 0=no pain, 10=the most severe pain), symptoms severity and functional impairment (using the Boston Carpal Tunnel Questionnaire; BCTQ), grip strength (using the Jamar hydraulic hand dynamometer in kilograms), median nerve cross-sectional area (CSA) (using diagnostic ultrasound at the carpal tunnel inlet), and quality of life (QoL) (using 36-Item Short Form Survey; SF-36) will be measured immediately before injection, at 4, 12, and 24 weeks post-injection.

The primary outcome measure will be the change in pain intensity at 4 weeks post-injection.

Secondary outcome measures will be the change in pain intensity at 12 and 24 weeks post-injection, and the changes in symptoms severity and functional impairment, grip strength, median nerve CSA, and QoL at 4, 12, and 24 weeks post-injection.

During the study, acetaminophen and tramadol will be allowed for occasional pain relief except for two days prior to the evaluation sessions due to possible interference with the results.

Physical therapy, use of wrist splints, acupuncture, and invasive interventions for CTS other than those included in the study protocol will not be allowed during the study.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Croatia
      • Knin, Croatia, 22300
        • Recruiting
        • General and Veteran Hospital "Croatian Pride" Knin
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Nadica Laktašić Žerjavić, Prof,MD,PhD.
        • Sub-Investigator:
          • Milan MIlošević, Prof,MD,PhD.
        • Sub-Investigator:
          • Željka Pandža, MD
        • Sub-Investigator:
          • Marija Anić Matić, Med.techn.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 5% dextrose injection
Ultrasound-guided 4 ml single injection of 5% dextrose
Drug: 5% dextrose injection
Single ultrasound-guided injection of 4 ml 5% dextrose in carpal tunnel via ulnar approach.
Other Names:
  • 5% dextrose
Active Comparator: 5% dextrose injections with methylprednisolone acetate
Ultrasound-guided single injection of 3 ml 5% dextrose plus 1 ml 40 mg/ml methylprednisolone acetate
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.
Other Names:
  • Depo-Medrol 40 mg/ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
before injection, 4 weeks post injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity at 12 and 24 weeks post injection
Time Frame: before injection,12 and 24 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.
before injection,12 and 24 weeks post injection.
Symptoms severity and functional impairment of carpal tunnel syndrome (CTS)
Time Frame: before injection, 4, 12 and 24 weeks post injection.
Assessment of CTS symptoms severity and functional impairment using the Boston Carpal Tunnel Questionnaire (BCTQ).
before injection, 4, 12 and 24 weeks post injection.
Grip strength
Time Frame: before injection, 4, 12 and 24 weeks post injection.
Assessment of grip strength using the Jamar hydraulic hand dynamometer in kilograms.
before injection, 4, 12 and 24 weeks post injection.
Median nerve cross-sectional area (CSA)
Time Frame: before injection, 4, 12 and 24 weeks post injection.
The CSA of the median nerve measured by diagnostic ultrasound at the level of carpal tunnel.
before injection, 4, 12 and 24 weeks post injection.
Quality of life (QoL)
Time Frame: before injection, 4, 12 and 24 weeks post injection.
Assessment of QoL using 36-Item Short Form Survey (SF-36).
before injection, 4, 12 and 24 weeks post injection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General and Veteran Hospital Croatian Pride Knin

Collaborators

Clinical Hospital Centre Zagreb
School of Public Health Andrija Štampar

Investigators

  • Principal Investigator: Igor Begović, MD, General and Veteran Hospital "Croatian Pride" Knin, Croatia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2023

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

August 30, 2026

Study Registration Dates

First Submitted

September 13, 2023

First Submitted That Met QC Criteria

September 13, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 510.01/23-01/76

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Carpal Tunnel Syndrome

Clinical Trials on 5% dextrose injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe