An Innovative Diagnostic Method for Carpal Tunnel SyndromeNCT03033173
Ratio of the Cross Sectional Area of Median Nerve to Ulnar Nerve in Diagnosing Carpal Tunnel Syndrome
An observational study of An Innovative Diagnostic Method for Carpal Tunnel Syndrome, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation.
Trial summary
An innovative diagnostic ultrasound method for carpal tunnel syndrome was proposed and compared between carpal tunnel syndrome patients and healthy volunteers. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- An Innovative Diagnostic Method for Carpal Tunnel Syndrome
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
About this study
An innovative diagnostic ultrasound method for carpal tunnel syndrome was proposed and compared between carpal tunnel syndrome patients and healthy volunteers.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CTS group | Not described | |
| Healthy subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sonographical findings between hands with CTS and healthy hands
Measured: Within one week after ultrasound examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study startJan 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for An Innovative Diagnostic Method for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03033173
- Sponsor's protocol ID
- TCRD-TPE-102-05
- Status last verified
- Jan 2017
- First submitted
- 18 Jan 2017
- Last updated
- 26 Jan 2017
- Results posted
- No
Publications
Chang YW, Hsieh TC, Tzeng IS, Chiu V, Huang PJ, Horng YS. Ratio and difference of the cross-sectional area of median nerve to ulnar nerve in diagnosing carpal tunnel syndrome: a case control study. BMC Med Imaging. 2019 Jul 4;19(1):52. doi: 10.1186/s12880-019-0351-3.
PubMed 31272405
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ratio of the Cross Sectional Area of Median Nerve to Ulnar Nerve in Diagnosing Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT03033173
- Acronym / sponsor ID
- TCRD-TPE-102-05
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 26 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An innovative diagnostic ultrasound method for carpal tunnel syndrome was proposed and compared between carpal tunnel syndrome patients and healthy volunteers.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTS group | – | – |
| Healthy subjects | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sonographical findings between hands with CTS and healthy hands
Time frame: Within one week after ultrasound examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
- Derived from this study: PubMed 31272405Chang YW, Hsieh TC, Tzeng IS, Chiu V, Huang PJ, Horng YS. Ratio and difference of the cross-sectional area of median nerve to ulnar nerve in diagnosing carpal tunnel syndrome: a case control study. BMC Med Imaging. 2019 Jul 4;19(1):52. doi: 10.1186/s12880-019-0351-3.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of An Innovative Diagnostic Method for Carpal Tunnel Syndrome, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sonographical findings between hands with CTS and healthy hands (time frame: Within one week after ultrasound examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03033173, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2017.