Carpal Tunnel SyndromeNCT06360510
Comparison of %5 Dextrose and Betamethasone Injections in Patients With Carpal Tunnel Syndrome
An observational study of Carpal Tunnel Syndrome, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- %5 dextrose injection and betamethasone injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2023to 5 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients that have carpal tunnel syndrome
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Ankara
About this study
Official title: 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).
Read the 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.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- %5 dextrose injection, betamethasone injection
- Keywords
- carpal tunnel syndrome, betamethasone, % 5 dextrose
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
%5 dextrose injectionProcedure or surgery
hydrodissection with %5 dextrose
betamethasone injectionProcedure or surgery
perineural betamethasone injection
| Study group | Role | What they receive |
|---|---|---|
| %5 dextrose group | Not described Receives: Procedure: %5 dextrose injection | |
| betamethasone group | Not described Receives: Procedure: betamethasone injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating scale - 10
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
Measured: three months
Secondary outcomes (5)
boston carpal tunnel syndrome questionnaire
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)
Measured: three months
median nerve cross sectional area
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.
Measured: three months
tinnel test positivity
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).
Measured: three months
phalen test positivity
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.
Measured: three months
DuruÖz hand index
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.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start5 May 2023
- Primary completion5 May 2024
- Study completion5 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360510
- Sponsor's protocol ID
- 44
- Status last verified
- Apr 2024
- First submitted
- 7 Apr 2024
- Last updated
- 23 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Ultrasound-guided 5% Dextrose and Betamethasone Injections in Patients With Carpal Tunnel Syndrome.
- ClinicalTrials.gov ID
- NCT06360510
- Acronym / sponsor ID
- 44
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- carpal tunnel syndrome, betamethasone, % 5 dextrose
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 5 May 2023 (actual)
- Primary completion
- 5 May 2024 (actual)
- Study completion
- 5 May 2024 (actual)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| %5 dextrose group | – | Procedure: %5 dextrose injection |
| betamethasone group | – | Procedure: betamethasone injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients that have carpal tunnel syndrome
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| %5 dextrose injectionhydrodissection with %5 dextrose | Procedure or surgery | %5 dextrose group |
| betamethasone injectionperineural betamethasone injection | Procedure or surgery | betamethasone group |
Primary outcome
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
5 secondary outcomes
boston carpal tunnel syndrome questionnaire
Time frame: three months
median nerve cross sectional area
Time frame: three months
tinnel test positivity
Time frame: three months
phalen test positivity
Time frame: three months
DuruÖz hand index
Time frame: three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel Syndrome, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric rating scale - 10 (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.