The Effect of Different Molecular Weight of HA for Carpal Tunnel Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Different Molecular Weight of Hyaluronic Acid for Patients With Carpal Tunnel Syndrome

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Procedure: Sono-guided injection with high molecular weight hyaluronic acid
* Procedure: Sono-guided injection with low molecular weight hyaluronic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 20-80 year-old. Diagnosis was confirmed using an electrophysiological study Exclusion Criteria: Cancer Coagulopathy Pregnancy Inflammation status Cervical radiculopathy Polyneuropathy, brachial plexopathy Thoracic outlet syndrome Previously undergone wrist surgery or steroid injection for CTS

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High molecular weight hyaluronic acid<br>Ultrasound-guided hydrodissection with high molecular weight hyaluronic acid between carpal tunnel and median nerve (total 2 times with one-week interval) | Procedure: Sono-guided injection with high molecular weight hyaluronic acid<br>* Sono-guided injection with hyaluronic acid (Aragan Plus, 20 mg/2 ml, 3000kDa) between carpal tunnel and median nerve<br>|
| Active Comparator: Low molecular weight hyaluronic acid<br>Ultrasound-guided hydrodissection with low molecular weight hyaluronic acid between carpal tunnel and median nerve (total 2 times with one-week interval) | Procedure: Sono-guided injection with low molecular weight hyaluronic acid<br>* Sono-guided injection with hyaluronic acid (ARTZDispo, 25 mg/2 ml, 600-1200kDa) between carpal tunnel and median nerve<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Pre-treatment, 2nd week, 1st, 3rd, 6th month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Pre-treatment, 2nd week, 1st, 3rd, 6th month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hydrodissection, hyaluronic acid