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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: |
NCT03031041 |
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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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Comparison of Difference Hydrodissection for CTS
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Scientific title:
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Comparison of Difference Hydrodissection Technique in Patients With Carpal Tunnel Syndrome |
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Date of first enrolment:
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January 25, 2017 |
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Target sample size:
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47 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03031041 |
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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: Single (Participant).
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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: Ultrasound-guided long-axis hydrodissection with 3cc normal saline
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Procedure: Ultrasound-guided short-axis hydrodissection with 5cc 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, 2nd, 3rd and 6th month after injection
[Time Frame: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection]
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Secondary Outcome(s)
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Change from baseline of conduction velocity, amplitude of median nerve on 2nd week, 1st, 2nd, 3rd and 6th month after injection
[Time Frame: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection]
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Change from baseline of finger pinch on 2nd week, 1st, 2nd, 3rd and 6th month after injection
[Time Frame: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection]
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Change from baseline of pain on 2nd week, 1st, 2nd, 3rd and 6th month after injection
[Time Frame: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection]
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Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 2nd, 3rd and 6th month after injection
[Time Frame: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection]
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Secondary ID(s)
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Difference PIT 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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