- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06360510
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Ankara, Turkey (Türkiye)
- Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
%5 dextrose group
|
hydrodissection with %5 dextrose
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betamethasone group
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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
The total score ranges from 0 to 90. Higher scores indicate greater functional impairment. |
three months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Wounds and Injuries
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Median Neuropathy
- Mononeuropathies
- Nerve Compression Syndromes
- Cumulative Trauma Disorders
- Sprains and Strains
- Carpal Tunnel Syndrome
- Polycyclic Compounds
- Pregnadienes
- Pregnanes
- Steroids
- Fused-Ring Compounds
- Steroids, Fluorinated
- Pregnadienetriols
- Betamethasone
Other Study ID Numbers
- 44
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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