Carpal Tunnel SyndromeNCT06188390
Hydrodissection in Carpal Tunnel Syndrome
A study testing Ultrasound guided median nerve hydrodissection injection with Hyaluronic acid and Ultrasound guided median nerve hydrodissection injection with Dextrose water in people with Carpal Tunnel Syndrome, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
Trial summary
Compare the efficacy on carpal tunnel syndrome (CTS) treatment between hydrodissection with hyaluronic acid (HA) vs 5% dextrose 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 median nerve hydrodissection injection with Hyaluronic acid and Ultrasound guided median nerve hydrodissection injection with Dextrose water
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2023to 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
- 20-80 years old patients with carpal tunnel syndrome
Who cannot join
- pregnancy, Diabetes, hypothyroidism, uremia, rheumatoid arthritis, coagulopathy, cervical radiculopathy and patients who has ever received surgery for carpal tunnel syndrome or wrist fracture
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Physical Medicine and Rehabilitation, Taipei Tzu chi Hospital, Buddhist Tzu chi Medical Foundation
New Taipei City, 231
Yi Wei Chang, MD, MS, 886-2-66289979 ext. 63521, vikt11010@gmail.com
About this study
Official title: Comparing Efficacy of Hydrodissection With Hyaluronic Acid vs 5% Dextrose for Carpal Tunnel Syndrome: A Randomized Controlled Trial and Ultrasonographic Evaluation of Median Nerve Gliding
Compare the efficacy on carpal tunnel syndrome (CTS) treatment between hydrodissection with hyaluronic acid (HA) vs 5% dextrose
Read the detailed description
Compare the efficacy on carpal tunnel syndrome treatment between hydrodissection with hyaluronic acid vs 5% dextrose through ultrasonographic evaluation.; 2) Evaluate the association of median nerve gliding results between using duplex Doppler ultrasound and B mode video with cross-correlation algorithm.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Ultrasound guided median nerve hydrodissection injection with Hyaluronic acid, Ultrasound guided median nerve hydrodissection injection with Dextrose water
- Keywords
- carpal tunnel syndrome, hydrodissection, ultrasonography, median nerve gliding
- 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 median nerve hydrodissection injection with Hyaluronic acidProcedure or surgery
Hyaluronic acid was injected under ultrasound guidance around median nerve at the wrist
Ultrasound guided median nerve hydrodissection injection with Dextrose waterProcedure or surgery
Dextrose water was injected under ultrasound guidance around median nerve at the wrist
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid group | Experimental | Hyaluronic acidwas injected under ultrasound guidance around wrist median nerve Receives: Procedure: Ultrasound guided median nerve hydrodissection injection with Hyaluronic acid |
| Dextrose group | Active comparator | Dextrose was injected under ultrasound guidance around wrist median nerve Receives: Procedure: Ultrasound guided median nerve hydrodissection injection with Dextrose water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston CTS (carpal tunnel syndrome) questionnaire
The Boston CTS questionnaire is self-administered and is composed of two parts: the symptom severity scale (11 questions) and the functional status scale (8 questions).A final score is calculated for each scale (the sum of the individual scores divided by the number of items) and ranges from 1 to 5, with a higher score indicating a more severe handicap.
Measured: before injection , 2 weeks, 3 months and 6 months after injection.
Secondary outcomes (3)
Ultrasonography (B mode) of median nerve
Transverse ultrasonograms were obtained at the level of pisiform bone. Using electronic calipers, the CSA of the median nerve was measured by tracing the margin of the inner border of the perineural hyperechogenic rim that surrounded the hypoechoic median nerve , unit : mm2
Measured: before injection , 2 weeks, 3 months and 6 months after injection.
Ultrasonography (duplex Doppler) of median nerve
An ultrasonography probe was placed longitudinally at the level of the lunate-capitate intercarpal joint to obtain a clear image of the median nerve. Longitudinal gliding excursions of the median nerve and flexor tendon were recorded using Doppler ultrasonography. The saved images were transferred to a personal coputer and analyzed by a researcher who was unaware of the individual and group identity of each image
Measured: before injection , 2 weeks, 3 months and 6 months after injection.
Nerve conduction study (NCS) of median nerve
Distal motor latencies of the median and ulnar nerve were respectively measured by placing a stimulating electrode at the wrist and a recording electrode 8 cm away from the stimulating electrode on the abductor pollicis brevis muscle and the adductor digiti minimi muscle. For sensory NCSs of the median and ulnar nerves, a standard distance of 14 cm was maintained between the stimulating electrode at the wrist and the recording electrodes at the ring finger on radial and ulnar sides
Measured: before injection , 3 months and 6 months after injection.
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 Jan 2023
- Primary completionJul 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188390
- Sponsor's protocol ID
- TCRD-TPE-112-20(1/2)
- Status last verified
- Dec 2023
- First submitted
- 17 Aug 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin MT, Liu IC, Syu WT, Kuo PL, Wu CH. Effect of Perineural Injection with Different Dextrose Volumes on Median Nerve Size, Elasticity and Mobility in Hands with Carpal Tunnel Syndrome. Diagnostics (Basel). 2021 May 9;11(5):849. doi: 10.3390/diagnostics11050849.
PubMed 34065073Su YC, Shen YP, Li TY, Ho TY, Chen LC, Wu YT. The Efficacy of Hyaluronic Acid for Carpal Tunnel Syndrome: A Randomized Double-Blind Clinical Trial. Pain Med. 2021 Nov 26;22(11):2676-2685. doi: 10.1093/pm/pnab109.
PubMed 33749798Babaei-Ghazani A, Moradnia S, Azar M, Forogh B, Ahadi T, Chaibakhsh S, Khodabandeh M, Eftekharsadat B. Ultrasound-guided 5% dextrose prolotherapy versus corticosteroid injection in carpal tunnel syndrome: a randomized, controlled clinical trial. Pain Manag. 2022 Sep;12(6):687-697. doi: 10.2217/pmt-2022-0018. Epub 2022 Jul 18.
PubMed 35848821
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
- Comparing Efficacy of Hydrodissection With Hyaluronic Acid vs 5% Dextrose for Carpal Tunnel Syndrome: A Randomized Controlled Trial and Ultrasonographic Evaluation of Median Nerve Gliding
- ClinicalTrials.gov ID
- NCT06188390
- Acronym / sponsor ID
- TCRD-TPE-112-20(1/2)
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- carpal tunnel syndrome, hydrodissection, ultrasonography, median nerve gliding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- 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.
Compare the efficacy on carpal tunnel syndrome (CTS) treatment between hydrodissection with hyaluronic acid (HA) vs 5% dextrose
Detailed description
Compare the efficacy on carpal tunnel syndrome treatment between hydrodissection with hyaluronic acid vs 5% dextrose through ultrasonographic evaluation.; 2) Evaluate the association of median nerve gliding results between using duplex Doppler ultrasound and B mode video with cross-correlation algorithm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid group | Experimental | Procedure: Ultrasound guided median nerve hydrodissection injection with Hyaluronic acidHyaluronic acidwas injected under ultrasound guidance around wrist median nerve |
| Dextrose group | Active comparator | Procedure: Ultrasound guided median nerve hydrodissection injection with Dextrose waterDextrose was injected under ultrasound guidance around wrist median nerve |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 20-80 years old patients with carpal tunnel syndrome
Key exclusion criteria (1 listed)
- pregnancy, Diabetes, hypothyroidism, uremia, rheumatoid arthritis, coagulopathy, cervical radiculopathy and patients who has ever received surgery for carpal tunnel syndrome or wrist fracture
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 median nerve hydrodissection injection with Hyaluronic acidHyaluronic acid was injected under ultrasound guidance around median nerve at the wrist | Procedure or surgery | Hyaluronic acid group |
| Ultrasound guided median nerve hydrodissection injection with Dextrose waterDextrose water was injected under ultrasound guidance around median nerve at the wrist | Procedure or surgery | Dextrose group |
Primary outcome
Boston CTS (carpal tunnel syndrome) questionnaire
Time frame: before injection , 2 weeks, 3 months and 6 months after injection.
The Boston CTS questionnaire is self-administered and is composed of two parts: the symptom severity scale (11 questions) and the functional status scale (8 questions).A final score is calculated for each scale (the sum of the individual scores divided by the number of items) and ranges from 1 to 5, with a higher score indicating a more severe handicap.
3 secondary outcomes
Ultrasonography (B mode) of median nerve
Time frame: before injection , 2 weeks, 3 months and 6 months after injection.
Ultrasonography (duplex Doppler) of median nerve
Time frame: before injection , 2 weeks, 3 months and 6 months after injection.
Nerve conduction study (NCS) of median nerve
Time frame: before injection , 3 months and 6 months after injection.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Results publication: PubMed 34065073Lin MT, Liu IC, Syu WT, Kuo PL, Wu CH. Effect of Perineural Injection with Different Dextrose Volumes on Median Nerve Size, Elasticity and Mobility in Hands with Carpal Tunnel Syndrome. Diagnostics (Basel). 2021 May 9;11(5):849. doi: 10.3390/diagnostics11050849.
- Results publication: PubMed 33749798Su YC, Shen YP, Li TY, Ho TY, Chen LC, Wu YT. The Efficacy of Hyaluronic Acid for Carpal Tunnel Syndrome: A Randomized Double-Blind Clinical Trial. Pain Med. 2021 Nov 26;22(11):2676-2685. doi: 10.1093/pm/pnab109.
- Results publication: PubMed 35848821Babaei-Ghazani A, Moradnia S, Azar M, Forogh B, Ahadi T, Chaibakhsh S, Khodabandeh M, Eftekharsadat B. Ultrasound-guided 5% dextrose prolotherapy versus corticosteroid injection in carpal tunnel syndrome: a randomized, controlled clinical trial. Pain Manag. 2022 Sep;12(6):687-697. doi: 10.2217/pmt-2022-0018. Epub 2022 Jul 18.
- 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.
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 median nerve hydrodissection injection with Hyaluronic acid and Ultrasound guided median nerve hydrodissection injection with Dextrose water in people with Carpal Tunnel Syndrome, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation 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 1 inclusion and 1 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 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 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 Yi Wei Chang, MD, MS (886-2-66289979 ext. 63521, vikt11010@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston CTS (carpal tunnel syndrome) questionnaire (time frame: before injection , 2 weeks, 3 months and 6 months after injection.). 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 NCT06188390, which also lists 3 linked publications.
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.