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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT02218229 |
Date of registration:
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13/08/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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The Effect of Extracorporeal Shock Wave Therapy on Carpal Tunnel Syndrome
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Scientific title:
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The Effect of Extracorporeal Shock Wave Therapy on Carpal Tunnel Syndrome |
Date of first enrolment:
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August 2014 |
Target sample size:
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60 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02218229 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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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 |
Address:
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Telephone:
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Email:
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Affiliation:
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Tri-Service General Hospital, School of Medicine, National Defense Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Outpatient subjects who had typical symptoms and signs of CTS, such as positive Tinel's
sign or Phalen's test and numbness/tingling in at least two of the first, second, and third
digits and were all confirmed by electrophysiological study, were considered and enrolled.
Exclusion Criteria:
The patients who had conditions mimicking CTS, such as cervical radiculopathy,
polyneuropathy, brachial plexopathy, thoracic outlet syndrome or who had previous wrist
surgery or steroid injection for CTS, were all excluded.
Age minimum:
18 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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Device: Shock wave
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Primary Outcome(s)
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Change from baseline of pain on1st, 2nd, 4th, 8th,12th and 16th weeks after treatment.
[Time Frame: Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks 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 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
[Time Frame: Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.]
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Change from baseline in conduction velocity, ampliture of median nerve on 1st, 2nd, 4th, 8th,12th and 16th weeks after treatment.
[Time Frame: Pre-treatment, 1st, 2nd, 4th, 8th,12th and 16th weeks after treatment.]
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Change from baseline in finger pinch on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
[Time Frame: Pre-treatment, 1st, 2nd, 4th, 8th,12th and 16th weeks after treatment.]
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Change from baseline in severity of symptoms and functional status on 1st, 2nd, 4th, 8th,12th and 16th weeks after treatment.
[Time Frame: Pre-treatment, 1st, 2nd, 4th, 8th,12th and 16th weeks after treatment.]
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Secondary ID(s)
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TSGHIRB: 1-102-05-122
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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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