The Effect of Different Molecular Weight of HA for Carpal Tunnel Syndrome
1 other identifier
interventional
20
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2021
CompletedFirst Posted
Study publicly available on registry
February 23, 2021
CompletedStudy Start
First participant enrolled
August 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2023
CompletedApril 10, 2024
April 1, 2024
2.2 years
February 20, 2021
April 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Change from baseline of pain on 2nd week, 1st, 3rd, 6th month after injection
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
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
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
Pre-treatment, 2nd week, 1st, 3rd, 6th month
Study Arms (2)
High molecular weight hyaluronic acid
EXPERIMENTALUltrasound-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 COMPARATORUltrasound-guided hydrodissection with low molecular weight hyaluronic acid between carpal tunnel and median nerve (total 2 times with one-week interval)
Interventions
Sono-guided injection with hyaluronic acid (Aragan Plus, 20 mg/2 ml, 3000kDa) between carpal tunnel and median nerve
Sono-guided injection with hyaluronic acid (ARTZDispo, 25 mg/2 ml, 600-1200kDa) between carpal tunnel and median nerve
Eligibility Criteria
You may qualify if:
- Age between 20-80 year-old.
- Diagnosis was confirmed using an electrophysiological study
You may not qualify if:
- Cancer
- Coagulopathy
- Pregnancy
- Inflammation status
- Cervical radiculopathy
- Polyneuropathy, brachial plexopathy
- Thoracic outlet syndrome
- Previously undergone wrist surgery or steroid injection for CTS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tri-Service General Hospital, School of Medicine, National Defense Medical Center
Taipei, Neihu, 886, Taiwan
Related Publications (4)
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.
PMID: 14705074BACKGROUNDBurns 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.
PMID: 8538160BACKGROUNDOzgenel 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.
PMID: 12593625BACKGROUNDAtzei 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.
PMID: 17205576BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Physician and associated professor of Department of Physical Medicine and Rehabilitation
Study Record Dates
First Submitted
February 20, 2021
First Posted
February 23, 2021
Study Start
August 1, 2021
Primary Completion
October 31, 2023
Study Completion
October 31, 2023
Last Updated
April 10, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL