Carpal Tunnel SyndromeNCT03598322
The Volume Effect of Hydrodissection for Carpal Tunnel Syndrome
A study testing Dextrose 1mL injection, Dextrose 2mL injection and Dextrose 4mL injection in people with Carpal Tunnel Syndrome, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The investigators investigated the volume effect of hydrodissection for Injection therapies in patients with Carpal Tunnel Syndrome. The investigators evaluated participants by Shear Wave Ultrasound Elastography and Artificial Intelligence Imaging Analysis 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?
- Dextrose 1mL injection, Dextrose 2mL injection and Dextrose 4mL injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Jun 2018to 30 Jul 2019
- 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 20-80
- Electrophysiological diagnosis of carpal tunnel syndrome
- At least one of the following two:
- Tenderness or numbness over median nerve innervated dermatome over 2 months
- Phalen test or Tinel sign or flick sign positive
Who cannot join
- History of wrist surgery
- Wrist trauma in recent two years
- Received wrist injection in recent three months
- History of brachial plexopathy, cervical radiculopathy or thoracic outlet syndrome
- History of DM, thyroid disorder or autoimmune disease
- Unable to cooperate with interview, examination or injection
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Physical Medicine & Rehabilitation , National Taiwan University Hospital
Taipei, 100
About this study
Official title: The Volume Effect of Hydrodissection for Injection Therapies in Patients With Carpal Tunnel Syndrome - Evaluation Model by Shear Wave Ultrasound Elastography and Artificial Intelligence Imaging Analysis
The investigators investigated the volume effect of hydrodissection for Injection therapies in patients with Carpal Tunnel Syndrome. The investigators evaluated participants by Shear Wave Ultrasound Elastography and Artificial Intelligence Imaging Analysis
Read the detailed description
The investigators investigated the volume effect of hydrodissection for Injection therapies in patients with Carpal Tunnel Syndrome. The investigators evaluated participants by Shear Wave Ultrasound Elastography and Artificial Intelligence Imaging Analysis
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Dextrose 1mL injection, Dextrose 2mL injection, Dextrose 4mL injection
- 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.
Dextrose 1mL injectionProcedure or surgery
Dextrose 1mL injection and hydrodissection for CTS
Dextrose 2mL injectionProcedure or surgery
Dextrose 2mL injection
Dextrose 4mL injectionProcedure or surgery
Dextrose 4mL injection
| Study group | Role | What they receive |
|---|---|---|
| Dextrose 1mL | Active comparator | Dextrose injection, Dextrose 1mL, active comparator Receives: Procedure: Dextrose 1mL injection |
| Dextrose 2mL | Experimental | Dextrose injection, Dextrose 2mL Receives: Procedure: Dextrose 2mL injection |
| Dextrose 4mL | Experimental | 'Dextrose injection, Dextrose 4mL Receives: Procedure: Dextrose 4mL injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Visual analog scale (VAS)
Change of Visual analog scale (VAS), from Baseline
Measured: 1 week, 4 weeks, 12 weeks, 24 weeks
Secondary outcomes (3)
Boston Carpal Tunnel Syndrome Questionnaire Score (BCTQ)
Boston Carpal Tunnel Syndrome Questionnaire Score (BCTQ), 19 items with each item scale 1-5
Measured: 1 week, 4 weeks, 12 weeks, 24 weeks
QuickDASH
QuickDASH (The Disabilities of the Arm, Shoulder and Hand Score(QuickDash)), 11 items with each item scale 1-5
Measured: 1 week, 4 weeks, 12 weeks, 24 weeks
MSK US finding
Cross-sectional area of median nerve
Measured: 1 week, 4 weeks, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start30 Jun 2018
- Primary completion1 Jul 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by National Taiwan 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chueh Hung Wu, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598322
- Sponsor's protocol ID
- 201711014RINA
- Status last verified
- Nov 2017
- First submitted
- 3 Jul 2018
- Last updated
- 6 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lin MT, Liao CL, Hsiao MY, Hsueh HW, Chao CC, Wu CH. Volume Matters in Ultrasound-Guided Perineural Dextrose Injection for Carpal Tunnel Syndrome: A Randomized, Double-Blinded, Three-Arm Trial. Front Pharmacol. 2020 Dec 17;11:625830. doi: 10.3389/fphar.2020.625830. eCollection 2020.
PubMed 33391002
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Volume Effect of Hydrodissection for Injection Therapies in Patients With Carpal Tunnel Syndrome - Evaluation Model by Shear Wave Ultrasound Elastography and Artificial Intelligence Imaging Analysis
- ClinicalTrials.gov ID
- NCT03598322
- Acronym / sponsor ID
- 201711014RINA
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 30 Jun 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 26 Jul 2018 (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 investigators investigated the volume effect of hydrodissection for Injection therapies in patients with Carpal Tunnel Syndrome. The investigators evaluated participants by Shear Wave Ultrasound Elastography and Artificial Intelligence Imaging Analysis
Detailed description
The investigators investigated the volume effect of hydrodissection for Injection therapies in patients with Carpal Tunnel Syndrome. The investigators evaluated participants by Shear Wave Ultrasound Elastography and Artificial Intelligence Imaging Analysis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dextrose 1mL | Active comparator | Procedure: Dextrose 1mL injectionDextrose injection, Dextrose 1mL, active comparator |
| Dextrose 2mL | Experimental | Procedure: Dextrose 2mL injectionDextrose injection, Dextrose 2mL |
| Dextrose 4mL | Experimental | Procedure: Dextrose 4mL injection'Dextrose injection, Dextrose 4mL |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 20-80
- Electrophysiological diagnosis of carpal tunnel syndrome
- At least one of the following two:
Key exclusion criteria (6 listed)
- History of wrist surgery
- Wrist trauma in recent two years
- Received wrist injection in recent three months
- History of brachial plexopathy, cervical radiculopathy or thoracic outlet syndrome
- History of DM, thyroid disorder or autoimmune disease
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 |
|---|---|---|
| Dextrose 1mL injectionDextrose 1mL injection and hydrodissection for CTS | Procedure or surgery | Dextrose 1mL |
| Dextrose 2mL injectionDextrose 2mL injection | Procedure or surgery | Dextrose 2mL |
| Dextrose 4mL injectionDextrose 4mL injection | Procedure or surgery | Dextrose 4mL |
Primary outcome
Change of Visual analog scale (VAS)
Time frame: 1 week, 4 weeks, 12 weeks, 24 weeks
Change of Visual analog scale (VAS), from Baseline
3 secondary outcomes
Boston Carpal Tunnel Syndrome Questionnaire Score (BCTQ)
Time frame: 1 week, 4 weeks, 12 weeks, 24 weeks
QuickDASH
Time frame: 1 week, 4 weeks, 12 weeks, 24 weeks
MSK US finding
Time frame: 1 week, 4 weeks, 12 weeks, 24 weeks
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 6 Sep 2019.
- Derived from this study: PubMed 33391002Lin MT, Liao CL, Hsiao MY, Hsueh HW, Chao CC, Wu CH. Volume Matters in Ultrasound-Guided Perineural Dextrose Injection for Carpal Tunnel Syndrome: A Randomized, Double-Blinded, Three-Arm Trial. Front Pharmacol. 2020 Dec 17;11:625830. doi: 10.3389/fphar.2020.625830. eCollection 2020.
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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.
Chueh Hung Wu, MD principal investigator
National Taiwan University 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 Dextrose 1mL injection, Dextrose 2mL injection and Dextrose 4mL injection in people with Carpal Tunnel Syndrome, run by National Taiwan 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 5 inclusion and 6 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 6 Sep 2019. 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?
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?
Change of Visual analog scale (VAS) (time frame: 1 week, 4 weeks, 12 weeks, 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03598322, which also lists 1 linked publication.
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 6 Sep 2019.