Carpal Tunnel SyndromePhase 4NCT07105540
Comparison of Injection Techniques in Carpal Tunnel Syndrome
A Phase 4 study testing 5% Dextrose and Betamethasone and local anesthetic in people with Carpal Tunnel Syndrome, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the effects of ultrasound-guided hydrodissection with 5% dextrose and perineural corticosteroid injection on the clinical parameters of carpal tunnel syndrome, as well as to evaluate the long-term efficacy of these treatments. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- 5% Dextrose and Betamethasone and local anesthetic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Aug 2025to 30 Mar 2026
- Phase
- Phase 4
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with unilateral moderate carpal tunnel syndrome (CTS) confirmed by an electrophysiological study within the last 6 months
- Presence of at least one of the following symptoms lasting more than one month:
- Paresthesia/dysesthesia accompanied by weakness and clumsiness in the hand, worsened by repetitive wrist use or sleep, and relieved by postural correction or shaking of the hand
- Numbness due to sensory disturbance in the median nerve (MN) distribution
- Thenar muscle weakness with atrophy
- Positive Tinel's sign or Phalen's test
- Pain intensity of ≥4 out of 10 on the Visual Analog Scale (VAS) prior to treatment
Who cannot join
- History of previous wrist surgery, polyneuropathy, brachial plexopathy, or thoracic outlet syndrome
- Presence of systemic infection
- Pregnancy
- Prior corticosteroid injection for CTS
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Etlik City Hospital
Ankara, Yenimahalle, 06370
About this study
Official title: Comparison of Hydrodissection With 5% Dextrose and Perineural Corticosteroid Injection in Carpal Tunnel Syndrome: A Prospective Study
The aim of this study is to compare the effects of ultrasound-guided hydrodissection with 5% dextrose and perineural corticosteroid injection on the clinical parameters of carpal tunnel syndrome, as well as to evaluate the long-term efficacy of these treatments.
Read the detailed description
Carpal tunnel syndrome (CTS), the most prevalent peripheral compressive neuropathy, manifests primarily with sensory disturbances such as pain, numbness, and nocturnal paresthesia. Treatment options for CTS differ considerably depending on the severity of symptoms, and typically include splinting, physiotherapy, local injection therapies, and surgical release. Hydrodissection is an ultrasound-guided technique that has recently gained increased attention for its role in the management of nerve entrapment syndromes. The technique uses fluid injection to separate the nerve from nearby tissues. This may reduce perineural adhesions and improve the patient's symptoms. In hydrodissection, normal saline, 5% dextrose, or platelet-rich plasma (PRP) can be used as injectates. Recently, hydrodissection with 5% dextrose has become the most commonly used approach. Several studies in the literature have demonstrated that perineural hydrodissection with 5% dextrose provides more favorable outcomes than corticosteroid injections in patients with mild to moderate CTS, particularly at 4 to 6 months post-injection. However, it remains unclear whether hydrodissection leads to a reduction in the cross-sectional area of the median nerve. In addition, studies examining the procedural details of hydrodissection are limited. Therefore, further clinical research is needed to better understand and validate the technique.
Ultrasound-guided hydrodissection for CTS is performed using a 12 MHz linear array transducer probe (GE Logiq P9, GE Healthcare, Boston, MA). The median nerve (MN) is visualized at the scaphoid-pisiform level. In the intervention group, 2.5 ml of 5% dextrose is injected via an in-plane ulnar approach to separate the MN from the transverse carpal ligament, followed by an additional 2.5 ml of normal saline (NS) injected to separate the MN from the flexor tendons. In the control group, perineural injection of 1 ml betamethasone is administered around the MN using the same ultrasound device and probe.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- 5% Dextrose, Betamethasone and local anesthetic
- Keywords
- Hydrodissection, Perineural Injection, Median Nerve
- 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% DextroseDrug
Ultrasound-guided hydrodissection is performed using a 12 MHz linear transducer (GE Logiq P9, GE Healthcare) via an in-plane ulnar approach under sterile conditions. 2.5 ml of 5% dextrose will be injected via an in-plane ulnar approach to mechanically separate the median nerve from the transverse carpal ligament. Subsequently, an additional 2.5 ml of 5% dextrose will be administered to separate the nerve from adjacent flexor tendons. The total injection volume will be 5 ml.
Betamethasone and local anestheticDrug
Ultrasound-guided perineural injection is performed using a 12 MHz linear transducer (GE Logiq P9, GE Healthcare) via an in-plane ulnar approach under sterile conditions. A total of 2 ml solution (1 ml betamethasone and 1 ml 2% lidocaine) is injected perineurally around the median nerve under ultrasound guidance at the scaphoid-pisiform level.
| Study group | Role | What they receive |
|---|---|---|
| Hydrodissection group | Active comparator | Participants in the hydrodissection group will undergo ultrasound-guided perineural hydrodissection of the median nerve at the scaphoid-pisiform level using a 12 MHz linear transducer (GE Logiq P9, GE Healthcare, Boston, MA). Under sterile conditions, 2.5 ml of 5% dextrose will be injected via an in-plane ulnar approach to mechanically separate the median nerve from the transverse carpal ligament. Subsequently, an additional 2.5 ml of 5% dextrose will be administered to separate the nerve from adjacent flexor tendons. The total injection volume will be 5 ml. Receives: Drug: 5% Dextrose |
| Corticosteroid group | Active comparator | Participants in the corticosteroid group will undergo ultrasound-guided perineural injection of the median nerve at the scaphoid-pisiform level using a 12 MHz linear transducer (GE Logiq P9, GE Healthcare, Boston, MA). A perineural injection of 1 ml betamethasone combined with 1 ml 2% lidocaine will be administered around the median nerve. Receives: Drug: Betamethasone and local anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Carpal Tunnel Questionnaire
The Boston Carpal Tunnel Questionnaire (BCTQ) is a validated disease-specific assessment tool developed in 1993 to provide standardized clinical evaluation of carpal tunnel syndrome (CTS). It comprises 19 items divided into two subscales: the Symptom Severity Scale (BCTQ-SSS) and the Functional Status Scale (BCTQ-FSS). Scores on both subscales range from 1 to 5, with higher scores reflecting increased symptom burden and functional impairment associated with CTS.
Measured: At baseline, at Month 1,3,6 (Visit 1,2,3)
Secondary outcomes (3)
Visual Analog Scale (VAS)
Patients rate their pain on a 0-10 scale. A lower score indicates reduced pain.
Measured: At baseline and at Month 1,3,6 (Visit 1,2,3)
Cross-Sectional Area (CSA) of the Median Nerve via Ultrasonography
Median nerve CSA will be measured at the scaphoid-pisiform level. A reduction in CSA indicates improvement.
Measured: At baseline and at month 3,6 (Visit 2,3)
Hand Grip Strength
Hand grip strength will be measured using a standard Jamar dynamometer. During the procedure, patients will be seated with the elbow flexed at 90° and the forearm in a neutral position. Three consecutive measurements will be taken, and the average value will be recorded. Improvement reflects functional recovery.
Measured: At baseline and at Month 3,6 (Visit 2,3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start5 Aug 2025
- Primary completion5 Feb 2026
- Study completion30 Mar 2026
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.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gizem Suna Tuncer, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105540
- Sponsor's protocol ID
- AE-FTR-GST-01
- Status last verified
- Apr 2026
- First submitted
- 14 Jul 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hydrodissection With 5% Dextrose and Perineural Corticosteroid Injection in Carpal Tunnel Syndrome: A Prospective Study
- ClinicalTrials.gov ID
- NCT07105540
- Acronym / sponsor ID
- AE-FTR-GST-01
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Hydrodissection, Perineural Injection, Median Nerve
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 5 Feb 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 6 Aug 2025 (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 this study is to compare the effects of ultrasound-guided hydrodissection with 5% dextrose and perineural corticosteroid injection on the clinical parameters of carpal tunnel syndrome, as well as to evaluate the long-term efficacy of these treatments.
Detailed description
Carpal tunnel syndrome (CTS), the most prevalent peripheral compressive neuropathy, manifests primarily with sensory disturbances such as pain, numbness, and nocturnal paresthesia. Treatment options for CTS differ considerably depending on the severity of symptoms, and typically include splinting, physiotherapy, local injection therapies, and surgical release. Hydrodissection is an ultrasound-guided technique that has recently gained increased attention for its role in the management of nerve entrapment syndromes. The technique uses fluid injection to separate the nerve from nearby tissues. This may reduce perineural adhesions and improve the patient's symptoms. In hydrodissection, normal saline, 5% dextrose, or platelet-rich plasma (PRP) can be used as injectates. Recently, hydrodissection with 5% dextrose has become the most commonly used approach. Several studies in the literature have demonstrated that perineural hydrodissection with 5% dextrose provides more favorable outcomes than corticosteroid injections in patients with mild to moderate CTS, particularly at 4 to 6 months post-injection. However, it remains unclear whether hydrodissection leads to a reduction in the cross-sectional area of the median nerve. In addition, studies examining the procedural details of hydrodissection are limited. Therefore, further clinical research is needed to better understand and validate the technique.
Ultrasound-guided hydrodissection for CTS is performed using a 12 MHz linear array transducer probe (GE Logiq P9, GE Healthcare, Boston, MA). The median nerve (MN) is visualized at the scaphoid-pisiform level. In the intervention group, 2.5 ml of 5% dextrose is injected via an in-plane ulnar approach to separate the MN from the transverse carpal ligament, followed by an additional 2.5 ml of normal saline (NS) injected to separate the MN from the flexor tendons. In the control group, perineural injection of 1 ml betamethasone is administered around the MN using the same ultrasound device and probe.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrodissection group | Active comparator | Drug: 5% DextroseParticipants in the hydrodissection group will undergo ultrasound-guided perineural hydrodissection of the median nerve at the scaphoid-pisiform level using a 12 MHz linear transducer (GE Logiq P9, GE Healthcare, Boston, MA). Under sterile conditions, 2.5 ml of 5% dextrose will be injected via an in-plane ulnar approach to mechanically separate the median nerve from the transverse carpal ligament. Subsequently, an additional 2.5 ml of 5% dextrose will be administered to separate the nerve from adjacent flexor tendons. The total injection volume will be 5 ml. |
| Corticosteroid group | Active comparator | Drug: Betamethasone and local anestheticParticipants in the corticosteroid group will undergo ultrasound-guided perineural injection of the median nerve at the scaphoid-pisiform level using a 12 MHz linear transducer (GE Logiq P9, GE Healthcare, Boston, MA). A perineural injection of 1 ml betamethasone combined with 1 ml 2% lidocaine will be administered around the median nerve. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients diagnosed with unilateral moderate carpal tunnel syndrome (CTS) confirmed by an electrophysiological study within the last 6 months
- Presence of at least one of the following symptoms lasting more than one month:
- Pain intensity of ≥4 out of 10 on the Visual Analog Scale (VAS) prior to treatment
Key exclusion criteria (4 listed)
- History of previous wrist surgery, polyneuropathy, brachial plexopathy, or thoracic outlet syndrome
- Presence of systemic infection
- Pregnancy
- Prior corticosteroid injection for CTS
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% DextroseUltrasound-guided hydrodissection is performed using a 12 MHz linear transducer (GE Logiq P9, GE Healthcare) via an in-plane ulnar approach under sterile conditions. 2.5 ml of 5% dextrose will be injected via an in-plane ulnar approach to mechanically separate the median nerve from the transverse carpal ligament. Subsequently, an additional 2.5 ml of 5% dextrose will be administered to separate the nerve from adjacent flexor tendons. The total injection volume will be 5 ml. | Drug | Hydrodissection group |
| Betamethasone and local anestheticUltrasound-guided perineural injection is performed using a 12 MHz linear transducer (GE Logiq P9, GE Healthcare) via an in-plane ulnar approach under sterile conditions. A total of 2 ml solution (1 ml betamethasone and 1 ml 2% lidocaine) is injected perineurally around the median nerve under ultrasound guidance at the scaphoid-pisiform level. | Drug | Corticosteroid group |
Primary outcome
Boston Carpal Tunnel Questionnaire
Time frame: At baseline, at Month 1,3,6 (Visit 1,2,3)
The Boston Carpal Tunnel Questionnaire (BCTQ) is a validated disease-specific assessment tool developed in 1993 to provide standardized clinical evaluation of carpal tunnel syndrome (CTS). It comprises 19 items divided into two subscales: the Symptom Severity Scale (BCTQ-SSS) and the Functional Status Scale (BCTQ-FSS). Scores on both subscales range from 1 to 5, with higher scores reflecting increased symptom burden and functional impairment associated with CTS.
3 secondary outcomes
Visual Analog Scale (VAS)
Time frame: At baseline and at Month 1,3,6 (Visit 1,2,3)
Cross-Sectional Area (CSA) of the Median Nerve via Ultrasonography
Time frame: At baseline and at month 3,6 (Visit 2,3)
Hand Grip Strength
Time frame: At baseline and at Month 3,6 (Visit 2,3)
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 21 Jul 2026.
- Individual participant dataSharing planned: No
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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?
A Phase 4 study testing 5% Dextrose and Betamethasone and local anesthetic in people with Carpal Tunnel Syndrome, run by Ankara Etlik City 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 7 inclusion and 4 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 21 Jul 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Boston Carpal Tunnel Questionnaire (time frame: At baseline, at Month 1,3,6 (Visit 1,2,3)). 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 21 Jul 2026.