Comparison of %5 Dextrose and Betamethasone Injections in Patients With Carpal Tunnel Syndrome

Comparison of the Effectiveness of Ultrasound-guided 5% Dextrose and Betamethasone Injections in Patients With Carpal Tunnel Syndrome.

The aim of the study is to compare the effectiveness of ultrasound-guided betamethasone and 5% dextrose injection, which is routinely applied in clinical practice, in patients with mild and moderate carpal tunnel syndrome (CTS).

Study Overview

Detailed Description

It is planned as an observational, single-center clinical study.A total of 28 patients diagnosed with mild-moderate carpal tunnel syndrome who meet the inclusion criteria will be included in the study.Patients who had been experiencing trigger finger symptoms for at least three month and who presented to the Gaziler Physical Medicine and Rehabilitation Training and Research Hospital, affiliated with the Health Sciences University Faculty of Medicine.

Patients will be divided into two groups. One group will receive 5% dextrose, the other group will receive 1 session of local injection by mixing Celeston chronodose [1ml/3 mg betamethasone acetate+3,947 mg betamethasone disodium phosphate (equivalent to 3 mg betamethasone)] and 1 ml 2% prilocaine.

Evaluations will be made before injection, at weeks 4 and 12.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

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

Study Locations

      • Ankara, Turkey (Türkiye)
        • Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

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

Sampling Method

Non-Probability Sample

Study Population

patients that have carpal tunnel syndrome

Description

Inclusion Criteria:

  • Paresthesia and pain symptoms in the region corresponding to the distribution of the median nerve
  • Detection of mild or moderate CTS by electromyography
  • One or both of the Phalen test and/or Tinel sign are positive on physical examination
  • Symptoms have persisted for at least 3 months

Exclusion Criteria:

  • Those diagnosed with polyneuropathy, plexopathy, radiculopathy, thoracic outlet syndrome
  • Having had surgery or any injection for carpal tunnel syndrome within the last year
  • History of wrist fracture
  • Those with rheumatoid arthritis, uncontrolled diabetes, gout, chronic renal failure, malignancy, active systemic infection
  • Those with cognitive impairment
  • Coagulopathy or bleeding tendency
  • Pregnancy

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
%5 dextrose group
hydrodissection with %5 dextrose
betamethasone group
perineural betamethasone injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric rating scale - 10
Time Frame: three months

The Numeric Rating Scale (NRS) is a simple and widely used tool for assessing pain intensity. Patients are asked to rate their pain on a scale from 0 to 10, where: 0 = No pain

1-3 = Mild pain

4-6 = Moderate pain

7-9 = Severe pain

10 = Worst pain imaginable

The patient selects the number that best represents their pain at last one week

three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
boston carpal tunnel syndrome questionnaire
Time Frame: three months

The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) is a disease-specific, patient-reported outcome measure used to assess symptom severity and functional status.1. Symptom Severity Scale (SSS)

Contains 11 items

Evaluates pain, numbness, tingling, weakness, nocturnal symptoms, and symptom frequency

Each item is scored on a 5-point Likert scale (1 = no symptoms, 5 = very severe symptoms)

2. Functional Status Scale (FSS)

Contains 8 items

Assesses difficulty in performing daily activities such as writing, buttoning clothes, holding a book, gripping a telephone, opening jars, and carrying grocery bags

Each item is scored from 1 (no difficulty) to 5 (cannot perform the activity)

three months
median nerve cross sectional area
Time Frame: three months
Median nerve cross-sectional area (CSA) refers to the measured area of the median nerve in a transverse (axial) plane, most commonly assessed using high-resolution ultrasonography.CSA measurements were performed using ultrasound at the scaphoid - pisiform bone level in the wrist, with results recorded in mm². To minimize measurement error, each measurement was performed three times, and the average of the three measurements was used for analysis.
three months
tinnel test positivity
Time Frame: three months

Tinel test positivity refers to the reproduction of distal paresthesia in the distribution of a nerve following percussion over the nerve at a suspected site of compression.

Definition of Positivity

The test is considered positive when tapping elicits:

Tingling

"Pins and needles" sensation (paresthesia)

Electric shock-like sensation

radiating into the median nerve distribution (thumb, index finger, middle finger, and radial half of the ring finger).

three months
phalen test positivity
Time Frame: three months

The Phalen test is performed by asking the patient to fully flex both wrists and maintain this position for approximately 60 seconds. This maneuver increases pressure within the carpal tunnel.

Definition of Positivity

The test is considered positive when the patient experiences:

Numbness

Tingling (paresthesia)

Burning sensation

Pain

in the distribution of the median nerve (thumb, index finger, middle finger, and radial half of the ring finger) during the maneuver.

three months
DuruÖz hand index
Time Frame: three months

The Duruöz Hand Index (DHI) is a patient-reported outcome measure developed to assess functional disability of the hand.Structure

The questionnaire consists of 18 items.

It assesses hand-related functional activities such as:

Turning a key

Buttoning clothes

Opening jars

Carrying objects

Using kitchen utensils

Scoring

Each item is scored on a 6-point Likert scale:

0 = Without difficulty

  1. = With slight difficulty
  2. = With moderate difficulty
  3. = With great difficulty
  4. = Nearly impossible
  5. = Impossible

The total score ranges from 0 to 90.

Higher scores indicate greater functional impairment.

three months

Collaborators and Investigators

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

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)

May 5, 2023

Primary Completion (Actual)

May 5, 2024

Study Completion (Actual)

May 5, 2024

Study Registration Dates

First Submitted

April 7, 2024

First Submitted That Met QC Criteria

April 7, 2024

First Posted (Actual)

April 11, 2024

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

April 1, 2024

More Information

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.

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