The Effect of Hyaluronic Acid for Carpal Tunnel Syndrome
1 other identifier
interventional
35
1 country
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2017
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2017
CompletedFirst Posted
Study publicly available on registry
January 25, 2017
CompletedStudy Start
First participant enrolled
March 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 28, 2019
CompletedOctober 31, 2019
October 1, 2019
2.7 years
January 21, 2017
October 29, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
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
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
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
Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year
Study Arms (2)
hyaluronic acid hydrodissection
EXPERIMENTALUltrasound-guided hydrodissection with 2.5cc hyaluronic acid between carpal tunnel and median nerve.
Normal saline hydrodissection
ACTIVE COMPARATORUltrasound-guided hydrodissection with 2.5cc normal saline between carpal tunnel and median nerve.
Interventions
Sono-guided injection with hyaluronic acid (ARTZDispo, 25 mg/2.5 ml) between carpal tunnel and median nerve
Sono-guided injection with 2.5cc Normal saline (0.9%) 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 (2)
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Tai Chung Municipality, Neihu District, 886, Taiwan
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Taipei, Neihu District, 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: 14705074RESULTBurns 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: 8538160RESULTOzgenel 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: 12593625RESULTAtzei 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: 17205576RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yung-Tsan Wu, MD
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
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 of Department of Physical Medicine and Rehabilitation
Study Record Dates
First Submitted
January 21, 2017
First Posted
January 25, 2017
Study Start
March 1, 2017
Primary Completion
October 28, 2019
Study Completion
October 28, 2019
Last Updated
October 31, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will share