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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03031054 |
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Date of registration:
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21/01/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Effect of Hyaluronic Acid for Carpal Tunnel Syndrome
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Scientific title:
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The Effect of Hyaluronic Acid in Patients With Carpal Tunnel Syndrome |
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Date of first enrolment:
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March 1, 2017 |
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Target sample size:
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35 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03031054 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Yung-Tsan Wu, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital |
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Key inclusion & exclusion 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
Age minimum:
20 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Carpal Tunnel Syndrome
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Intervention(s)
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Procedure: Sono-guided injection with hyaluronic acid
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Procedure: Sono-guided injection with normal saline
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Primary Outcome(s)
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Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 3rd, 6th month and one year after injection
[Time Frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year]
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Secondary Outcome(s)
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Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 3rd, 6th month and one year after injection
[Time Frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year]
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Change from baseline of conduction velocity, amplitude of median nerve on 2nd week, 1st, 3rd, 6th month and one year after injection
[Time Frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year]
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Change from baseline of finger pinch on 2nd week, 1st, 3rd, 6th month and one year after injection
[Time Frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year]
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Change from baseline of pain on 2nd week, 1st, 3rd, 6th month and one year after injection
[Time Frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year]
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Secondary ID(s)
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HA for CTS
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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