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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: |
NCT03184688 |
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Date of registration:
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07/06/2017 |
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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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Platelet Rich Plasma for Carpal Tunnel Syndrome
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Scientific title:
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The Long-term Effect of Platelet-rich Plasma in Patients With Carpal Tunnel Syndrome: a Prospective Randomized Double-blind Controlled Trial |
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Date of first enrolment:
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September 8, 2017 |
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Target sample size:
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26 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03184688 |
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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: Triple (Participant, Investigator, 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
- 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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Drug: Normal saline
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Procedure: platelet rich plasma
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Primary Outcome(s)
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Change from baseline of pain on 2nd week, 1st, 3rd, 6th month and one year after the treatment.
[Time Frame: Baseline, 2nd week, 1st, 3rd, 6th month and one year after treatment.]
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Secondary Outcome(s)
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Change from baseline in cross-sectional area of the median nerve on 2nd week, 1st, 3rd, 6th month and one year after the treatment.
[Time Frame: Baseline, 2nd week, 1st, 3rd, 6th month and one year after treatment.]
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Change from baseline in severity of symptoms and functional status on 2nd week, 1st, 3rd, 6th month and one year after the treatment.
[Time Frame: Baseline, 2nd week, 1st, 3rd, 6th month and one year after treatment.]
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Change from baseline in conduction velocity, amplitude of median nerve on 2nd week, 1st, 3rd, 6th month and one year after the treatment.
[Time Frame: Baseline, 2nd week, 1st, 3rd, 6th month and one year after treatment.]
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Change from baseline in finger pinch on 2nd week, 1st, 3rd, 6th month and one year after the treatment.
[Time Frame: Baseline, 2nd week, 1st, 3rd, 6th month and one year after treatment.]
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Secondary ID(s)
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Perineural PRP 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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