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

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ClinicalTrials.gov Identifier: NCT04766918
Recruitment Status : Recruiting
First Posted : February 23, 2021
Last Update Posted : April 27, 2022
Sponsor:
Information provided by (Responsible Party):
Yung-Tsan Wu, Tri-Service General Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Procedure: Sono-guided injection with high molecular weight hyaluronic acid Procedure: Sono-guided injection with low molecular weight hyaluronic acid Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Different Molecular Weight of Hyaluronic Acid for Patients With Carpal Tunnel Syndrome
Actual Study Start Date : August 1, 2021
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: High molecular weight hyaluronic acid
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
Sono-guided injection with hyaluronic acid (Aragan Plus, 20 mg/2 ml, 3000kDa) between carpal tunnel and median nerve
Active Comparator: Low molecular weight hyaluronic acid
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
Sono-guided injection with hyaluronic acid (ARTZDispo, 25 mg/2 ml, 600-1200kDa) between carpal tunnel and median nerve


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 3rd, 6th month after injection [ Time Frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month ]
    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 :
  1. Change from baseline of pain on 2nd week, 1st, 3rd, 6th month after injection [ Time Frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month ]
    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.

  2. Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 3rd, 6th month after injection [ Time Frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month ]
    Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve before treatment and multiple time frame after treatment.

  3. Change from baseline of conduction velocity, amplitude of median nerve on 2nd week, 1st, 3rd, 6th month after injection [ Time Frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month ]
    electrophysiological study of the median nerve before treatment and multiple time frame after treatment.

  4. Change from baseline of mobility of median nerve on 2nd week, 1st, 3rd, 6th month after injection [ Time Frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month ]
    Using the musculoskeletal sonogram to measure the mobility of the median nerve before treatment and multiple time frame after treatment.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04766918


Contacts
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Contact: Yung-Tsan Wu, MD +886287923311 crwu98@gmail.com
Contact: Yung-Tsan Wu +886287923311 crwu98@gmail.com

Locations
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Taiwan
Tri-Service General Hospital, School of Medicine, National Defense Medical Center Recruiting
Taipei, Neihu, Taiwan, 886
Contact: Yung-Tsan Wu, MD    +886-2-8792-3311 ext 17068    crwu98@gmail.com   
Principal Investigator: Yung-Tsan Wu, MD         
Sponsors and Collaborators
Tri-Service General Hospital
More Information
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Publications:

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Responsible Party: Yung-Tsan Wu, Attending Physician and associated professor of Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT04766918    
Other Study ID Numbers: Different molecular HA for CTS
First Posted: February 23, 2021    Key Record Dates
Last Update Posted: April 27, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yung-Tsan Wu, Tri-Service General Hospital:
Hydrodissection
hyaluronic acid
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
 Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents