The Effect of Hyaluronic Acid for Carpal Tunnel Syndrome
Primary Purpose
Carpal Tunnel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Sono-guided injection with hyaluronic acid
Sono-guided injection with normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Hydrodissection, hyaluronic acid
Eligibility Criteria
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
Sites / Locations
- Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
- Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
hyaluronic acid hydrodissection
Normal saline hydrodissection
Arm Description
Ultrasound-guided hydrodissection with 2.5cc hyaluronic acid between carpal tunnel and median nerve.
Ultrasound-guided hydrodissection with 2.5cc normal saline between carpal tunnel and median nerve.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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
Full Information
NCT ID
NCT03031054
First Posted
January 21, 2017
Last Updated
October 29, 2019
Sponsor
Tri-Service General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03031054
Brief Title
The Effect of Hyaluronic Acid for Carpal Tunnel Syndrome
Official Title
The Effect of Hyaluronic Acid in Patients With Carpal Tunnel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
October 28, 2019 (Actual)
Study Completion Date
October 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tri-Service General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
Hydrodissection, hyaluronic acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hyaluronic acid hydrodissection
Arm Type
Experimental
Arm Description
Ultrasound-guided hydrodissection with 2.5cc hyaluronic acid between carpal tunnel and median nerve.
Arm Title
Normal saline hydrodissection
Arm Type
Active Comparator
Arm Description
Ultrasound-guided hydrodissection with 2.5cc normal saline between carpal tunnel and median nerve.
Intervention Type
Procedure
Intervention Name(s)
Sono-guided injection with hyaluronic acid
Intervention Description
Sono-guided injection with hyaluronic acid (ARTZDispo, 25 mg/2.5 ml) between carpal tunnel and median nerve
Intervention Type
Procedure
Intervention Name(s)
Sono-guided injection with normal saline
Intervention Description
Sono-guided injection with 2.5cc Normal saline (0.9%) between carpal tunnel and median nerve
Primary Outcome Measure Information:
Title
Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 3rd, 6th month and one year after injection
Description
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.
Time Frame
Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year
Secondary Outcome Measure Information:
Title
Change from baseline of pain on 2nd week, 1st, 3rd, 6th month and one year after injection
Description
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.
Time Frame
Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year
Title
Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 3rd, 6th month and one year after injection
Description
Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve before treatment and multiple time frame after treatment.
Time Frame
Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year
Title
Change from baseline of conduction velocity, amplitude of median nerve on 2nd week, 1st, 3rd, 6th month and one year after injection
Description
electrophysiological study of the median nerve before treatment and multiple time frame after treatment.
Time Frame
Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year
Title
Change from baseline of finger pinch on 2nd week, 1st, 3rd, 6th month and one year after injection
Description
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
Time Frame
Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yung-Tsan Wu, MD
Organizational Affiliation
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
City
Tai Chung Municipality
State/Province
Neihu District
ZIP/Postal Code
886
Country
Taiwan
Facility Name
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
City
Taipei
State/Province
Neihu District
ZIP/Postal Code
886
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
14705074
Citation
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.
Results Reference
result
PubMed Identifier
8538160
Citation
Burns 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 Reference
result
PubMed Identifier
12593625
Citation
Ozgenel 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 Reference
result
PubMed Identifier
17205576
Citation
Atzei 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.
Results Reference
result
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The Effect of Hyaluronic Acid for Carpal Tunnel Syndrome
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