Carpal Tunnel SyndromeNCT05423028
Vitamin B12 and Dextrose for Median Nerve Hydrodissection
A study testing Ultrasound-guided nerve hydrodissection in people with Carpal Tunnel Syndrome, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
Carpal tunnel syndrome is the most common peripheral entrapment neuropathy of the upper limb. Previous experiments found that ultrasound-guided median nerve hydrodissection with 5% dextrose water could ameliorate the condition of carpal tunnel syndrome. 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?
- Ultrasound-guided nerve hydrodissection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Dec 2021to Dec 2024
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20-80 year-old.
- Diagnosis (carpal tunnel syndrome) was confirmed using an electrophysiological study.
Who cannot join
- Previously undergone wrist surgery or steroid injection for CTS
- Thrombocytopenia
- Coagulopathy
- Inflammation status
- Polyneuropathy
- Brachial plexopathy
Show all 11Show fewer
- Cervical radiculopathy
- Autoimmune disease
- Malignancy
- Pregnancy
- Thoracic outlet syndrome
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University
Tainan
Yao-Hong Guo, MD, MSc, 886-6-2353535 ext. 2666, drprps@gmail.com
About this study
Official title: The Effects of Vitamin B12 and Dextrose on the Ultrasound-guided Median Nerve Hydrodissection
Carpal tunnel syndrome is the most common peripheral entrapment neuropathy of the upper limb. Previous experiments found that ultrasound-guided median nerve hydrodissection with 5% dextrose water could ameliorate the condition of carpal tunnel syndrome. Oral administration of vitamin B 12 had been reported to reduce the discomfort from peripheral neuropathy although the level of evidence is not strong. This prospective, double-blind randomized control trial aims to compare the effects of different kinds of the injection agents on carpal tunnel syndrome.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Ultrasound-guided nerve hydrodissection
- 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.
Ultrasound-guided nerve hydrodissectionProcedure or surgery
Peri- median nerve injection for hydrorelease and decompression
| Study group | Role | What they receive |
|---|---|---|
| Dextrose | Active comparator | Not described Receives: Procedure: Ultrasound-guided nerve hydrodissection |
| Vitamin B12 | Experimental | Not described Receives: Procedure: Ultrasound-guided nerve hydrodissection |
| Dextrose + Vitamin B12 | Experimental | Not described Receives: Procedure: Ultrasound-guided nerve hydrodissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Boston Carpal Tunnel Syndrome Questionnaire
Measure the severity of symptoms and functional status before and after treatment
Measured: Pre-treatment, 1st, 3rd, 6th month after injection
Secondary outcomes (4)
Visual analog scale of pain and tingling
Measure the pain and tingling scale before treatment and after treatment. (0 is for not at all pain/tingling, and 100 is for extremely pain/tingling.)
Measured: Pre-treatment, 1st, 3rd, 6th month after injection
Cross-sectional area of the median nerve
Using the ultrasound to measure the cross-sectional area of the median nerve before and after treatment
Measured: Pre-treatment, 1st, 3rd, 6th month after injection
Median nerve elastography
Using the ultrasound to measure the elastography of the median nerve before and after treatment
Measured: Pre-treatment, 1st, 3rd, 6th month after injection
Median nerve conduction velocity and amplitude
Antidromic sensory nerve conduction velocity and amplitude of the median nerve before and after treatment
Measured: Pre-treatment, 1st, 6th month after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start7 Dec 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
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 National Cheng-Kung University 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423028
- Sponsor's protocol ID
- NCKUH-11103036
- Status last verified
- Mar 2024
- First submitted
- 6 Jun 2022
- Last updated
- 21 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Vitamin B12 and Dextrose on the Ultrasound-guided Median Nerve Hydrodissection
- ClinicalTrials.gov ID
- NCT05423028
- Acronym / sponsor ID
- NCKUH-11103036
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 21 Jun 2022 (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.
Carpal tunnel syndrome is the most common peripheral entrapment neuropathy of the upper limb. Previous experiments found that ultrasound-guided median nerve hydrodissection with 5% dextrose water could ameliorate the condition of carpal tunnel syndrome. Oral administration of vitamin B 12 had been reported to reduce the discomfort from peripheral neuropathy although the level of evidence is not strong. This prospective, double-blind randomized control trial aims to compare the effects of different kinds of the injection agents on carpal tunnel syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dextrose | Active comparator | Procedure: Ultrasound-guided nerve hydrodissection |
| Vitamin B12 | Experimental | Procedure: Ultrasound-guided nerve hydrodissection |
| Dextrose + Vitamin B12 | Experimental | Procedure: Ultrasound-guided nerve hydrodissection |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 20-80 year-old.
- Diagnosis (carpal tunnel syndrome) was confirmed using an electrophysiological study.
Key exclusion criteria (11 listed)
- Previously undergone wrist surgery or steroid injection for CTS
- Thrombocytopenia
- Coagulopathy
- Inflammation status
- Polyneuropathy
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 |
|---|---|---|
| Ultrasound-guided nerve hydrodissectionPeri- median nerve injection for hydrorelease and decompression | Procedure or surgery | Dextrose, Dextrose + Vitamin B12, Vitamin B12 |
Primary outcome
Change of Boston Carpal Tunnel Syndrome Questionnaire
Time frame: Pre-treatment, 1st, 3rd, 6th month after injection
Measure the severity of symptoms and functional status before and after treatment
4 secondary outcomes
Visual analog scale of pain and tingling
Time frame: Pre-treatment, 1st, 3rd, 6th month after injection
Cross-sectional area of the median nerve
Time frame: Pre-treatment, 1st, 3rd, 6th month after injection
Median nerve elastography
Time frame: Pre-treatment, 1st, 3rd, 6th month after injection
Median nerve conduction velocity and amplitude
Time frame: Pre-treatment, 1st, 6th month after injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Individual participant dataSharing planned: Yes
Related trials for Carpal Tunnel Syndrome
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
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Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
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Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Effect of Progressive Gamified Motor Rehabilitation After Carpal Tunnel Release
Carpal Tunnel Surgery
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided nerve hydrodissection in people with Carpal Tunnel Syndrome, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 2 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 21 Mar 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yao-Hong Guo, MD, MSc (886-6-2353535 ext. 2666, drprps@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Boston Carpal Tunnel Syndrome Questionnaire (time frame: Pre-treatment, 1st, 3rd, 6th month after injection). 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 Mar 2024.