Skip to main content
OpenTrials
Completed

NCT Number: NCT06360510

Comparison of %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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

%5 dextrose injection

Procedure

hydrodissection with %5 dextrose

betamethasone injection

Procedure

perineural betamethasone injection

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

    • 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)

  2. 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.

  3. 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).

  4. 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.

  5. 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

    • = With slight difficulty
    • = With moderate difficulty
    • = With great difficulty
    • = Nearly impossible
    • = Impossible

    The total score ranges from 0 to 90.

    Higher scores indicate greater functional impairment.

Sponsors and collaborators

Lead sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 11, 2024
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.