Carpal Tunnel SyndromeNCT06189651
Short Term Efficacy of 5% Dextrose Injection With Ultrasound Guided Nerve Hydrodissection Method in CTS
A study testing wrist splint and 5% dextrose injection using USG-guided nerve hydrodissection method in people with Carpal Tunnel Syndrome, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Hydrodissection injection method; It is a safe and effective injection method in peripheral nerve compression that aims to release the adhesions by separating the nerve from the surrounding connective tissues through the liquid given by injection. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- wrist splint and 5% dextrose injection using USG-guided nerve hydrodissection method
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 12 Dec 2023
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with clinical symptoms for at least 3 months
- Patients with paresthesia or dysesthesia in the fingers
- Patients diagnosed with mild or moderate carpal tunnel syndrome by EMG
Who cannot join
- Patients with severe carpal tunnel syndrome
- Patients with polyneuropathy, cervical radiculopathy, brachial plexopathy and thoracic outlet syndrome
- Patients with a history of wrist surgery
- Patients within 6 months of steroid injection for carpal tunnel syndrome
- Patients with infection at the treatment site
- Patients with coagulation disorders or on coumadin
Show all 9Show fewer
- Pregnant patients
- Patients with a history of malignancy, rheumatologic disease
- Patients with any other painful pathology in the upper extremity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Istanbul
About this study
Official title: Short-Term Efficacy of 5% Dextrose Injection With Ultrasound Guided Nerve Hydrodissection Method in Carpal Tunnel Syndrome: Prospective Randomized Controlled Study
Hydrodissection injection method; It is a safe and effective injection method in peripheral nerve compression that aims to release the adhesions by separating the nerve from the surrounding connective tissues through the liquid given by injection. Perineural injection of 5% dextrose is analgesic in neuropathic pain, although the mechanism is not fully defined. USG-guided 5% dextrose injection using nerve hydrodissection method is promising in the treatment of CTS. In our study, we aimed to investigate the short-term (4 weeks) efficacy of 5% dextrose injection using USG-guided nerve hydrodissection method in combination with wrist splint treatment in patients with mild to moderate carpal tunnel syndrome (CTS) and whether this treatment can provide additional benefit to wrist splint treatment.
Read the detailed description
In our prospective randomized controlled study, 44 patients who met the inclusion criteria and had mild to moderate carpal measured syndrome with EMG as described in previous studies were included in the study. The 44 volunteer participants with mild to moderate carpal tunnel syndrome were randomly divided into 2 groups as wrist splint treatment group (control group) and wrist splint + 5% dextrose injection treatment group (study group) by stratified and block randomization method. Stratified randomization was done according to the variable of having mild and moderate carpal tunnel syndrome. Assignment to the treatment or control group for each stratum was done by 1:1 block randomization.
All patients were given the same type of wrist splint to be used for at least 8 hours at night for 4 weeks, to be worn in a neutral position and in accordance with the wrist as described in previous studies to restrict movement in the wrist, and activities that aggravate symptoms (repetitive and demanding wrist movements: Knitting, keyboard use, use of vibrating tools, etc.) were recommended to be avoided. The given wrist splint is a commercially available wrist splint with a metal bar on the palmar side and Velcro straps on the dorsal side that can be adjusted according to the wrist, restricting flexion and extension of the wrist and allowing movement of the metacarpophalangeal joint. Patients who did not sleep for 8 hours were asked to complete 8 hours of wrist splint use before going to sleep or after waking up. All patients were given a wrist splint diary and asked to write down the days and hours of splinting. Patients who did not wear splints for enough days and hours were excluded from the study. In the study group, 2 ml each of 5% dextrose injection was administered once at the proximal wrist level above the median nerve separating the median nerve from the flexor retinaculum and below the median nerve separating the median nerve from the flexor tendons by nerve hydrodissection method in the transverse inplane plane under ultrasound guidance. After the application, the spread of the injectate was observed by looking longitudinally at the median nerve. A 25 gauge syringe was used for administration. Patients were observed for side effects and side effects were noted. Patients were asked to rate their injection pain on a Visual Analog Scale (VAS) after injection to measure the pain during injection. All patients were advised not to take any additional treatment for their symptoms during the study. Patients who received additional treatment were noted. All patients were evaluated with Visual Analog Scale (VAS) score, Turkish version of Boston Carpal Tunnel Questionnaire (BCTQ), grip strength (GS) measured by hand dynamometer, and median nerve cross-sectional area (CSA) measured by ultrasonography before the start of the study (week 0) and at the end of the 4th week.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- wrist splint, 5% dextrose injection using USG-guided nerve hydrodissection method
- Keywords
- carpal tunnel syndrome, hydrodissection, 5% dextrose, wrist splint
- 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.
wrist splintDevice
The same type of wrist splint to be used for at least 8 hours at night for 4 weeks, to be worn in a neutral position and in accordance with the wrist as described in previous studies to restrict movement in the wrist. Patients who did not sleep for 8 hours were asked to complete 8 hours of wrist splint use before going to sleep or after waking up.
5% dextrose injection using USG-guided nerve hydrodissection methodProcedure or surgery
2 ml each of 5% dextrose injection was administered once at the proximal wrist level above the median nerve separating the median nerve from the flexor retinaculum and below the median nerve separating the median nerve from the flexor tendons by nerve hydrodissection method in the transverse inplane plane under ultrasound guidance. After the application, the spread of the injectate was observed by looking longitudinally at the median nerve.
| Study group | Role | What they receive |
|---|---|---|
| Wrist splint treatment | Experimental | The same type of wrist splint was given Receives: Device: wrist splint |
| Wrist splint treatment+ %5 dextrose injection | Experimental | The same type of wrist splint was given and 5% dextrose injection using USG-guided nerve hydrodissection method was applied Receives: Device: wrist splint; Procedure: 5% dextrose injection using USG-guided nerve hydrodissection method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
VAS was used to measure the severity of pain-paresthesia. Patients were given a white paper with a horizontal straight line with numbers from 0 to 10. The patients were told that the left-hand side of the line described gradually decreasing pain and the right-hand side described gradually increasing pain and that a score of 0 corresponded to no pain-paresthesia and a score of 10 corresponded to intolerable pain-paresthesia and were asked to mark a number on the scale.
Measured: Start of the study (week 0) and at the end of the 4th week.
Boston Carpal Tunnel Questionnaire (BCTQ)
The BCTQ includes an eleven-question symptom severity scale (BCTQS) and an eight-question functional status scale (BCTQF) that assesses the degree of difficulty in daily activities. Symptom severity ranges from 11 (no symptoms) to 55 (severe symptoms). The functional status scale ranges from 8 (least difficulty) to 40 (maximum difficulty). Turkish version has been tested for reliability and validity.
Measured: Start of the study (week 0) and at the end of the 4th week.
Secondary outcomes (2)
Grip Strength (GS)
Maximal voluntary grip strength (GS) was measured with a hand dynamometer. This measurement was performed as described in previous studies; sitting, shoulders in adduction and neutral position, elbow in 90° flexion, forearm and wrist in neutral position. The measurements were performed three times. For each measurement, patients were asked to perform a maximal voluntary grip for five seconds. A rest period of 10 seconds was given between the three tests. The measurements were performed with a JAMAR Plus+ (by Sammons Preston) hand dynamometer. The average of these three measurements was used in the analysis. Before the test measurements, the patient was shown how to use the device practically.
Measured: Start of the study (week 0) and at the end of the 4th week.
Median Nerve Cross Sectional Area (CSA)
CSA was measured axially on the wrist at the scaphoid-psiform bone level. The measurement results were expressed in mm2. CSA measurements were performed by the same investigator. In order to determine the level of intra-observer error, CSA measurements were performed twice in 10 subjects with an interval of one day. Intraobserver error was calculated using the technical error of measurements (TEM) method.
Measured: Start of the study (week 0) and at the end of the 4th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start1 Nov 2021
- Primary completion1 Nov 2022
- Study completion12 Dec 2023
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, clinical trials
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nazlı Derya Bugdayci, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Investigators
- Nazli Derya Bugdayci, Assoc. Prof., Study director, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189651
- Sponsor's protocol ID
- STEDIUGNHMCTS
- Status last verified
- Dec 2023
- First submitted
- 19 Dec 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Efficacy of 5% Dextrose Injection With Ultrasound Guided Nerve Hydrodissection Method in Carpal Tunnel Syndrome: Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06189651
- Acronym / sponsor ID
- STEDIUGNHMCTS
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- carpal tunnel syndrome, hydrodissection, 5% dextrose, wrist splint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 3 Jan 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.
Hydrodissection injection method; It is a safe and effective injection method in peripheral nerve compression that aims to release the adhesions by separating the nerve from the surrounding connective tissues through the liquid given by injection. Perineural injection of 5% dextrose is analgesic in neuropathic pain, although the mechanism is not fully defined. USG-guided 5% dextrose injection using nerve hydrodissection method is promising in the treatment of CTS. In our study, we aimed to investigate the short-term (4 weeks) efficacy of 5% dextrose injection using USG-guided nerve hydrodissection method in combination with wrist splint treatment in patients with mild to moderate carpal tunnel syndrome (CTS) and whether this treatment can provide additional benefit to wrist splint treatment.
Detailed description
In our prospective randomized controlled study, 44 patients who met the inclusion criteria and had mild to moderate carpal measured syndrome with EMG as described in previous studies were included in the study. The 44 volunteer participants with mild to moderate carpal tunnel syndrome were randomly divided into 2 groups as wrist splint treatment group (control group) and wrist splint + 5% dextrose injection treatment group (study group) by stratified and block randomization method. Stratified randomization was done according to the variable of having mild and moderate carpal tunnel syndrome. Assignment to the treatment or control group for each stratum was done by 1:1 block randomization.
All patients were given the same type of wrist splint to be used for at least 8 hours at night for 4 weeks, to be worn in a neutral position and in accordance with the wrist as described in previous studies to restrict movement in the wrist, and activities that aggravate symptoms (repetitive and demanding wrist movements: Knitting, keyboard use, use of vibrating tools, etc.) were recommended to be avoided. The given wrist splint is a commercially available wrist splint with a metal bar on the palmar side and Velcro straps on the dorsal side that can be adjusted according to the wrist, restricting flexion and extension of the wrist and allowing movement of the metacarpophalangeal joint. Patients who did not sleep for 8 hours were asked to complete 8 hours of wrist splint use before going to sleep or after waking up. All patients were given a wrist splint diary and asked to write down the days and hours of splinting. Patients who did not wear splints for enough days and hours were excluded from the study. In the study group, 2 ml each of 5% dextrose injection was administered once at the proximal wrist level above the median nerve separating the median nerve from the flexor retinaculum and below the median nerve separating the median nerve from the flexor tendons by nerve hydrodissection method in the transverse inplane plane under ultrasound guidance. After the application, the spread of the injectate was observed by looking longitudinally at the median nerve. A 25 gauge syringe was used for administration. Patients were observed for side effects and side effects were noted. Patients were asked to rate their injection pain on a Visual Analog Scale (VAS) after injection to measure the pain during injection. All patients were advised not to take any additional treatment for their symptoms during the study. Patients who received additional treatment were noted. All patients were evaluated with Visual Analog Scale (VAS) score, Turkish version of Boston Carpal Tunnel Questionnaire (BCTQ), grip strength (GS) measured by hand dynamometer, and median nerve cross-sectional area (CSA) measured by ultrasonography before the start of the study (week 0) and at the end of the 4th week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, clinical trials
| Arm | Type | Receives |
|---|---|---|
| Wrist splint treatment | Experimental | Device: wrist splintThe same type of wrist splint was given |
| Wrist splint treatment+ %5 dextrose injection | Experimental | Device: wrist splint, Procedure: 5% dextrose injection using USG-guided nerve hydrodissection methodThe same type of wrist splint was given and 5% dextrose injection using USG-guided nerve hydrodissection method was applied |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with clinical symptoms for at least 3 months
- Patients with paresthesia or dysesthesia in the fingers
- Patients diagnosed with mild or moderate carpal tunnel syndrome by EMG
Key exclusion criteria (9 listed)
- Patients with severe carpal tunnel syndrome
- Patients with polyneuropathy, cervical radiculopathy, brachial plexopathy and thoracic outlet syndrome
- Patients with a history of wrist surgery
- Patients within 6 months of steroid injection for carpal tunnel syndrome
- Patients with infection at the treatment site
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 |
|---|---|---|
| wrist splintThe same type of wrist splint to be used for at least 8 hours at night for 4 weeks, to be worn in a neutral position and in accordance with the wrist as described in previous studies to restrict movement in the wrist. Patients who did not sleep for 8 hours were asked to complete 8 hours of wrist splint use before going to sleep or after waking up. | Device | Wrist splint treatment, Wrist splint treatment+ %5 dextrose injection |
| 5% dextrose injection using USG-guided nerve hydrodissection method2 ml each of 5% dextrose injection was administered once at the proximal wrist level above the median nerve separating the median nerve from the flexor retinaculum and below the median nerve separating the median nerve from the flexor tendons by nerve hydrodissection method in the transverse inplane plane under ultrasound guidance. After the application, the spread of the injectate was observed by looking longitudinally at the median nerve. | Procedure or surgery | Wrist splint treatment+ %5 dextrose injection |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: Start of the study (week 0) and at the end of the 4th week.
VAS was used to measure the severity of pain-paresthesia. Patients were given a white paper with a horizontal straight line with numbers from 0 to 10. The patients were told that the left-hand side of the line described gradually decreasing pain and the right-hand side described gradually increasing pain and that a score of 0 corresponded to no pain-paresthesia and a score of 10 corresponded to intolerable pain-paresthesia and were asked to mark a number on the scale.
Boston Carpal Tunnel Questionnaire (BCTQ)
Time frame: Start of the study (week 0) and at the end of the 4th week.
The BCTQ includes an eleven-question symptom severity scale (BCTQS) and an eight-question functional status scale (BCTQF) that assesses the degree of difficulty in daily activities. Symptom severity ranges from 11 (no symptoms) to 55 (severe symptoms). The functional status scale ranges from 8 (least difficulty) to 40 (maximum difficulty). Turkish version has been tested for reliability and validity.
2 secondary outcomes
Grip Strength (GS)
Time frame: Start of the study (week 0) and at the end of the 4th week.
Median Nerve Cross Sectional Area (CSA)
Time frame: Start of the study (week 0) and at the end of the 4th week.
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 3 Jan 2024.
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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.
Nazli Derya Bugdayci, Assoc. Prof. study director
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wrist splint and 5% dextrose injection using USG-guided nerve hydrodissection method in people with Carpal Tunnel Syndrome, run by Istanbul Physical Medicine Rehabilitation Training 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 3 inclusion and 9 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 3 Jan 2024. 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?
Visual Analogue Scale (VAS) (time frame: Start of the study (week 0) and at the end of the 4th week.). The study lists 2 primary outcomes in all. 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 3 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.