Carpal Tunnel SyndromeNCT04766918
The Effect of Different Molecular Weight of HA for Carpal Tunnel Syndrome
A study testing Sono-guided injection with high molecular weight hyaluronic acid and Sono-guided injection with low molecular weight hyaluronic acid in people with Carpal Tunnel Syndrome, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
Recently, nerve hydrodissection is utilized to assist ultrasound-guided nerve injection and studies recommend its clinical benefit for peripheral entrapment neuropathy. Hyaluronic acid (HA) can decrease the post-surgery adhesion of soft tissue and nerve but its clinical application in clinical practice is very rare. 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?
- Sono-guided injection with high molecular weight hyaluronic acid and Sono-guided injection with low molecular weight hyaluronic acid
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2021to 31 Oct 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 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 was confirmed using an electrophysiological study
Who cannot join
- Cancer
- Coagulopathy
- Pregnancy
- Inflammation status
- Cervical radiculopathy
- Polyneuropathy, brachial plexopathy
- Thoracic outlet syndrome
- Previously undergone wrist surgery or steroid injection for CTS
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Tri-Service General Hospital, School of Medicine, National Defense Medical Center
Taipei, Neihu, 886
About this study
Official title: The Effect of Different Molecular Weight of Hyaluronic Acid for Patients With Carpal Tunnel Syndrome
Recently, nerve hydrodissection is utilized to assist ultrasound-guided nerve injection and studies recommend its clinical benefit for peripheral entrapment neuropathy. Hyaluronic acid (HA) can decrease the post-surgery adhesion of soft tissue and nerve but its clinical application in clinical practice is very rare.
We just proved that single HA injection have short-term effectiveness in mild-to-moderate carpal tunnel (CTS) cases and this finding may hint the therapeutic effectiveness of nerve hydrodissection for CTS depend on absorption time of solution. In addition, no study compare different weight of HA for nerve injection so far. Hence, the purpose of this study aim to compare different weight of HA for CTS and whether hydrodissection effect depend on the absorption time of solution or not.
Read the detailed description
Participants established with diagnosis of mild-to-moderate CTS will been randomly assigned to high molecular weight HA (Aragan Plus, 20 mg/2 ml, 3000kDa) or low molecular weight HA (ARTZDispo, 25 mg/2.5 ml, 600-1200kDa) groups. With ultrasound guidance, total two-sessions of high or low molecular weight HA with one week interval will been injected into intra-carpal region. The Boston Carpal Tunnel Syndrome Questionnaire is assigned as primary outcome. The secondary outcomes encompass visual analog scale, electrophysiological studies, cross-sectional area of the median nerve, mobility of median nerve and absorption time of HA. The assessment is performed prior injection and at 2 week, 1, 2, 3 and 6 months post-injection.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Sono-guided injection with high molecular weight hyaluronic acid, Sono-guided injection with low molecular weight hyaluronic acid
- Keywords
- Hydrodissection, hyaluronic acid
- 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.
Sono-guided injection with high molecular weight hyaluronic acidProcedure or surgery
Sono-guided injection with hyaluronic acid (Aragan Plus, 20 mg/2 ml, 3000kDa) between carpal tunnel and median nerve
Sono-guided injection with low molecular weight hyaluronic acidProcedure or surgery
Sono-guided injection with hyaluronic acid (ARTZDispo, 25 mg/2 ml, 600-1200kDa) between carpal tunnel and median nerve
| Study group | Role | What they receive |
|---|---|---|
| High molecular weight hyaluronic acid | Experimental | Ultrasound-guided hydrodissection with high molecular weight hyaluronic acid between carpal tunnel and median nerve (total 2 times with one-week interval) Receives: Procedure: Sono-guided injection with high molecular weight hyaluronic acid |
| Low molecular weight hyaluronic acid | Active comparator | Ultrasound-guided hydrodissection with low molecular weight hyaluronic acid between carpal tunnel and median nerve (total 2 times with one-week interval) Receives: Procedure: Sono-guided injection with low molecular weight hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 3rd, 6th month after injection
Boston carpal tunnel syndrome questionnaire (BCTQ) is a frequently used patient-based questionnaire for measurement of CTS which encompasses two components. In total, 11 questions and 8 items were evaluated to rate the symptom severity scale (SSS) and functional status scale (FSS), respectively. Both subscales range from 1 to 5 with a higher score indicating a higher degree of disability. The mean of total SSS and FSS divided with each item score were used for further analysis.
Measured: Pre-treatment, 2nd week, 1st, 3rd, 6th month
Secondary outcomes (4)
Change from baseline of pain on 2nd week, 1st, 3rd, 6th month after injection
Digital pain severity or paresthesia/dysthesia was evaluated using visual analog scale (VAS). Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain.
Measured: Pre-treatment, 2nd week, 1st, 3rd, 6th month
Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 3rd, 6th month after injection
Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve before treatment and multiple time frame after treatment.
Measured: Pre-treatment, 2nd week, 1st, 3rd, 6th month
Change from baseline of conduction velocity, amplitude of median nerve on 2nd week, 1st, 3rd, 6th month after injection
electrophysiological study of the median nerve before treatment and multiple time frame after treatment.
Measured: Pre-treatment, 2nd week, 1st, 3rd, 6th month
Change from baseline of mobility of median nerve on 2nd week, 1st, 3rd, 6th month after injection
Using the musculoskeletal sonogram to measure the mobility of the median nerve before treatment and multiple time frame after treatment.
Measured: Pre-treatment, 2nd week, 1st, 3rd, 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start1 Aug 2021
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yung-Tsan Wu, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766918
- Sponsor's protocol ID
- Different molecular HA for CTS
- Status last verified
- Apr 2024
- First submitted
- 20 Feb 2021
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Ozgenel GY. Effects of hyaluronic acid on peripheral nerve scarring and regeneration in rats. Microsurgery. 2003;23(6):575-81. doi: 10.1002/micr.10209.
PubMed 14705074Burns JW, Skinner K, Colt J, Sheidlin A, Bronson R, Yaacobi Y, Goldberg EP. Prevention of tissue injury and postsurgical adhesions by precoating tissues with hyaluronic acid solutions. J Surg Res. 1995 Dec;59(6):644-52. doi: 10.1006/jsre.1995.1218.
PubMed 8538160Ozgenel GY, Filiz G. Effects of human amniotic fluid on peripheral nerve scarring and regeneration in rats. J Neurosurg. 2003 Feb;98(2):371-7. doi: 10.3171/jns.2003.98.2.0371.
PubMed 12593625Atzei A, Calcagni M, Breda B, Fasolo G, Pajardi G, Cugola L. Clinical evaluation of a hyaluronan-based gel following microsurgical reconstruction of peripheral nerves of the hand. Microsurgery. 2007;27(1):2-7. doi: 10.1002/micr.20299.
PubMed 17205576
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Molecular Weight of Hyaluronic Acid for Patients With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT04766918
- Acronym / sponsor ID
- Different molecular HA for CTS
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Hydrodissection, hyaluronic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 23 Feb 2021 (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.
Recently, nerve hydrodissection is utilized to assist ultrasound-guided nerve injection and studies recommend its clinical benefit for peripheral entrapment neuropathy. Hyaluronic acid (HA) can decrease the post-surgery adhesion of soft tissue and nerve but its clinical application in clinical practice is very rare.
We just proved that single HA injection have short-term effectiveness in mild-to-moderate carpal tunnel (CTS) cases and this finding may hint the therapeutic effectiveness of nerve hydrodissection for CTS depend on absorption time of solution. In addition, no study compare different weight of HA for nerve injection so far. Hence, the purpose of this study aim to compare different weight of HA for CTS and whether hydrodissection effect depend on the absorption time of solution or not.
Detailed description
Participants established with diagnosis of mild-to-moderate CTS will been randomly assigned to high molecular weight HA (Aragan Plus, 20 mg/2 ml, 3000kDa) or low molecular weight HA (ARTZDispo, 25 mg/2.5 ml, 600-1200kDa) groups. With ultrasound guidance, total two-sessions of high or low molecular weight HA with one week interval will been injected into intra-carpal region. The Boston Carpal Tunnel Syndrome Questionnaire is assigned as primary outcome. The secondary outcomes encompass visual analog scale, electrophysiological studies, cross-sectional area of the median nerve, mobility of median nerve and absorption time of HA. The assessment is performed prior injection and at 2 week, 1, 2, 3 and 6 months post-injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High molecular weight hyaluronic acid | Experimental | Procedure: Sono-guided injection with high molecular weight hyaluronic acidUltrasound-guided hydrodissection with high molecular weight hyaluronic acid between carpal tunnel and median nerve (total 2 times with one-week interval) |
| Low molecular weight hyaluronic acid | Active comparator | Procedure: Sono-guided injection with low molecular weight hyaluronic acidUltrasound-guided hydrodissection with low molecular weight hyaluronic acid between carpal tunnel and median nerve (total 2 times with one-week interval) |
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 was confirmed using an electrophysiological study
Key exclusion criteria (8 listed)
- Cancer
- Coagulopathy
- Pregnancy
- Inflammation status
- Cervical radiculopathy
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 |
|---|---|---|
| Sono-guided injection with high molecular weight hyaluronic acidSono-guided injection with hyaluronic acid (Aragan Plus, 20 mg/2 ml, 3000kDa) between carpal tunnel and median nerve | Procedure or surgery | High molecular weight hyaluronic acid |
| Sono-guided injection with low molecular weight hyaluronic acidSono-guided injection with hyaluronic acid (ARTZDispo, 25 mg/2 ml, 600-1200kDa) between carpal tunnel and median nerve | Procedure or surgery | Low molecular weight hyaluronic acid |
Primary outcome
Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 3rd, 6th month after injection
Time frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month
Boston carpal tunnel syndrome questionnaire (BCTQ) is a frequently used patient-based questionnaire for measurement of CTS which encompasses two components. In total, 11 questions and 8 items were evaluated to rate the symptom severity scale (SSS) and functional status scale (FSS), respectively. Both subscales range from 1 to 5 with a higher score indicating a higher degree of disability. The mean of total SSS and FSS divided with each item score were used for further analysis.
4 secondary outcomes
Change from baseline of pain on 2nd week, 1st, 3rd, 6th month after injection
Time frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month
Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 3rd, 6th month after injection
Time frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month
Change from baseline of conduction velocity, amplitude of median nerve on 2nd week, 1st, 3rd, 6th month after injection
Time frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month
Change from baseline of mobility of median nerve on 2nd week, 1st, 3rd, 6th month after injection
Time frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month
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 10 Apr 2024.
- Background: PubMed 14705074Ozgenel GY. Effects of hyaluronic acid on peripheral nerve scarring and regeneration in rats. Microsurgery. 2003;23(6):575-81. doi: 10.1002/micr.10209.
- Background: PubMed 8538160Burns JW, Skinner K, Colt J, Sheidlin A, Bronson R, Yaacobi Y, Goldberg EP. Prevention of tissue injury and postsurgical adhesions by precoating tissues with hyaluronic acid solutions. J Surg Res. 1995 Dec;59(6):644-52. doi: 10.1006/jsre.1995.1218.
- Background: PubMed 12593625Ozgenel GY, Filiz G. Effects of human amniotic fluid on peripheral nerve scarring and regeneration in rats. J Neurosurg. 2003 Feb;98(2):371-7. doi: 10.3171/jns.2003.98.2.0371.
- Background: PubMed 17205576Atzei A, Calcagni M, Breda B, Fasolo G, Pajardi G, Cugola L. Clinical evaluation of a hyaluronan-based gel following microsurgical reconstruction of peripheral nerves of the hand. Microsurgery. 2007;27(1):2-7. doi: 10.1002/micr.20299.
- 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
Carpal Tunnel Syndrome (CTS), Postural Assessment
Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies
Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
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.
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 study testing Sono-guided injection with high molecular weight hyaluronic acid and Sono-guided injection with low molecular weight hyaluronic acid in people with Carpal Tunnel Syndrome, run by Tri-Service General Hospital (TSGH) 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 8 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 10 Apr 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?
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 from baseline of severity of symptoms and functional status on 2nd week, 1st, 3rd, 6th month after injection (time frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month). 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 NCT04766918, which also lists 4 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 10 Apr 2024.