Carpal Tunnel SyndromeNCT03031054
The Effect of Hyaluronic Acid for Carpal Tunnel Syndrome
A study testing Sono-guided injection with hyaluronic acid and Sono-guided injection with normal saline in people with Carpal Tunnel Syndrome, run by Tri-Service General Hospital (TSGH) at 2 sites in Taiwan.
Trial summary
Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. Rather than other progressive disease, CTS is characterized by remission and recurrence. 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 hyaluronic acid and Sono-guided injection with normal saline
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesTaiwan
- Study dates
- 1 Mar 2017to 28 Oct 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 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
2 sites in 1 country.
Taiwan2 sites
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Tai Chung Municipality, Neihu District, 886
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Taipei, Neihu District, 886
About this study
Official title: The Effect of Hyaluronic Acid in Patients With Carpal Tunnel Syndrome
Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. Rather than other progressive disease, CTS is characterized by remission and recurrence. The hydrodissection could decrease the entrapment of nerve to restore blood supply. In addition, the hyaluronic acid was proved to decrease adhension of soft tissue and nerve during operation. The investigators design a randomized, double-blind, controlled trial to assess the effect after ultrasound-guided hydrodissection with hyaluronic acid in patients with CTS.
Read the detailed description
After obtaining written informed consent, patients with bilateral CTS will been randomized into intervention and control group. Participants in intervention group received one-dose ultrasound-guided hydrodissection with hyaluronic acid and control side received one-dose ultrasound-guided injection with normal saline. No additional treatment after injection through the study period. The primary outcome is Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and secondary outcomes include visual analog scale (VAS), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve, and finger pinch strength. The evaluation was performed pretreatment as well as on the 2nd week, 1st, 3rd, 6th month and one year after the treatment.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Sono-guided injection with hyaluronic acid, Sono-guided injection with normal saline
- 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 hyaluronic acidProcedure or surgery
Sono-guided injection with hyaluronic acid (ARTZDispo, 25 mg/2.5 ml) between carpal tunnel and median nerve
Sono-guided injection with normal salineProcedure or surgery
Sono-guided injection with 2.5cc Normal saline (0.9%) between carpal tunnel and median nerve
| Study group | Role | What they receive |
|---|---|---|
| hyaluronic acid hydrodissection | Experimental | Ultrasound-guided hydrodissection with 2.5cc hyaluronic acid between carpal tunnel and median nerve. Receives: Procedure: Sono-guided injection with hyaluronic acid |
| Normal saline hydrodissection | Active comparator | Ultrasound-guided hydrodissection with 2.5cc normal saline between carpal tunnel and median nerve. Receives: Procedure: Sono-guided injection with normal saline |
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 and one year 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 and one year
Secondary outcomes (4)
Change from baseline of pain on 2nd week, 1st, 3rd, 6th month and one year 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 and one year
Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 3rd, 6th month and one year 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 and one year
Change from baseline of conduction velocity, amplitude of median nerve on 2nd week, 1st, 3rd, 6th month and one year 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 and one year
Change from baseline of finger pinch on 2nd week, 1st, 3rd, 6th month and one year after injection
The finger pinch strength was measured using dynamometer (Fabrication Enterprises Inc., USA). The subject was seated with shoulder adducted and neutrally rotated with the elbow flexed at 90°. The forearm and wrist were positioned in a neutral position for the palmar pinch
Measured: Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study start1 Mar 2017
- Primary completion28 Oct 2019
- Study completion28 Oct 2019
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
- 35 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)
- Investigators
- Yung-Tsan Wu, MD, Principal investigator, Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031054
- Sponsor's protocol ID
- HA for CTS
- Status last verified
- Oct 2019
- First submitted
- 21 Jan 2017
- Last updated
- 31 Oct 2019
- 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 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hyaluronic Acid in Patients With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT03031054
- Acronym / sponsor ID
- HA for CTS
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Hydrodissection, hyaluronic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 28 Oct 2019 (actual)
- Study completion
- 28 Oct 2019 (actual)
- First posted
- 25 Jan 2017 (estimated)
- 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 (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. Rather than other progressive disease, CTS is characterized by remission and recurrence. The hydrodissection could decrease the entrapment of nerve to restore blood supply. In addition, the hyaluronic acid was proved to decrease adhension of soft tissue and nerve during operation. The investigators design a randomized, double-blind, controlled trial to assess the effect after ultrasound-guided hydrodissection with hyaluronic acid in patients with CTS.
Detailed description
After obtaining written informed consent, patients with bilateral CTS will been randomized into intervention and control group. Participants in intervention group received one-dose ultrasound-guided hydrodissection with hyaluronic acid and control side received one-dose ultrasound-guided injection with normal saline. No additional treatment after injection through the study period. The primary outcome is Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and secondary outcomes include visual analog scale (VAS), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve, and finger pinch strength. The evaluation was performed pretreatment as well as on the 2nd week, 1st, 3rd, 6th month and one year after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyaluronic acid hydrodissection | Experimental | Procedure: Sono-guided injection with hyaluronic acidUltrasound-guided hydrodissection with 2.5cc hyaluronic acid between carpal tunnel and median nerve. |
| Normal saline hydrodissection | Active comparator | Procedure: Sono-guided injection with normal salineUltrasound-guided hydrodissection with 2.5cc normal saline between carpal tunnel and median nerve. |
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 hyaluronic acidSono-guided injection with hyaluronic acid (ARTZDispo, 25 mg/2.5 ml) between carpal tunnel and median nerve | Procedure or surgery | hyaluronic acid hydrodissection |
| Sono-guided injection with normal salineSono-guided injection with 2.5cc Normal saline (0.9%) between carpal tunnel and median nerve | Procedure or surgery | Normal saline hydrodissection |
Primary outcome
Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 3rd, 6th month and one year after injection
Time frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year
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 and one year after injection
Time frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year
Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 3rd, 6th month and one year after injection
Time frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year
Change from baseline of conduction velocity, amplitude of median nerve on 2nd week, 1st, 3rd, 6th month and one year after injection
Time frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year
Change from baseline of finger pinch on 2nd week, 1st, 3rd, 6th month and one year after injection
Time frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year
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 31 Oct 2019.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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 recruitingObservational study
Symptom Recovery Time After the Phalen Test in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS)
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.
Yung-Tsan Wu, MD principal investigator
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
2 sites 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 hyaluronic acid and Sono-guided injection with normal saline in people with Carpal Tunnel Syndrome, run by Tri-Service General Hospital (TSGH) at 2 sites 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 31 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 and one year after injection (time frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year). 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 NCT03031054, 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 31 Oct 2019.