- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03033173
Ratio of the Cross Sectional Area of Median Nerve to Ulnar Nerve in Diagnosing Carpal Tunnel Syndrome
January 24, 2017 updated by: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
An innovative diagnostic ultrasound method for carpal tunnel syndrome was proposed and compared between carpal tunnel syndrome patients and healthy volunteers.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
74
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
CTS patients were recruited from the Physical Medicine and Rehabilitation Department of Taipei Tzu Chi hospital.
Healthy subjects were recruited from hospital staff, health volunteers and their friends.
Description
Inclusion Criteria:
- CTS patients were required to have subjective symptoms of numbness, tingling pain, or dysesthesia over the median nerve innervated area of the involved hand.
- Patients should have positive response in either Tinel's test or Phalen's test during physical examination
- Evidence of median neuropathy at wrist level in NCS.
- Control subjects should have neither symptoms nor signs of CTS along with no abnormal findings in electrodiagnostic study of the median nerve and the ulnar nerve across the wrist joint.
Exclusion Criteria:
- Age younger than 20 years old
- Electrodiagnostic evidence of ulnar neuropathy at the wrist level
- Previous trauma or surgery history of hand
- Medical history of hypothyroidism, diabetes mellitus, uremia, rheumatoid arthritis, amyloidosis, and acromegaly
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Healthy subjects
|
|
CTS group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Sonographical findings between hands with CTS and healthy hands
Time Frame: Within one week after ultrasound examination
|
Within one week after ultrasound examination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2013
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
January 18, 2017
First Submitted That Met QC Criteria
January 24, 2017
First Posted (Estimate)
January 26, 2017
Study Record Updates
Last Update Posted (Estimate)
January 26, 2017
Last Update Submitted That Met QC Criteria
January 24, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TCRD-TPE-102-05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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