Carpal Tunnel SyndromeNCT04027998
Median Nerve Strain and Applied Pressure Measurement in the Carpal Tunnel Syndrome Patients
An observational study of Carpal Tunnel Syndrome, run by Tokyo Medical University at 1 site in Japan.
Trial summary
The aim of this study is to investigate diagnostic accuracy of median nerve strain and applied pressure measurement . Idiopathic carpal tunnel syndrome patients and healthy controls will be evaluated by ultrasound. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- strain and applied pressure measurement
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- 3 Apr 2015to 31 Dec 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: carpal tunnel syndrome patients and asymptomatic control
Who may be able to join
- carpal tunnel syndrome patients and asymptomatic control
Who cannot join
- Patients were excluded if there was a history of cervical radiculopathy, rheumatoid arthritis, gout, hemodialysis, sarcoidosis, amyloidosis, or traumatic injuries to the arm. Written consent was obtained from all study participants
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Tokyo Medical University Ibaraki Medical Center
Ami, Ibaraki, 300-0395
Yuichi Yoshii, 81298871161, yy12721@yahoo.co.jp
About this study
The aim of this study is to investigate diagnostic accuracy of median nerve strain and applied pressure measurement . Idiopathic carpal tunnel syndrome patients and healthy controls will be evaluated by ultrasound. Median nerve strain, pressure applied to the skin will be measured at the proximal part of the carpal tunnel. The parameters will be compared between patients and controls, and before and after the open carpal tunnel release in the patients.
Read the detailed description
The aim of this study is to investigate diagnostic accuracy of median nerve strain and applied pressure measurement . Idiopathic carpal tunnel syndrome patients and healthy controls will be evaluated by ultrasound. Median nerve strain, pressure applied to the skin, and ratio of pressure-strain will be measured at the proximal part of the carpal tunnel. In addition, distal latencies in the motor and sensory nerve conductions studies and cross-sectional area of median nerve will be measured. The parameters will be compared between patients and controls, and before and after the open carpal tunnel release in the patients.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- strain and applied pressure measurement
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
strain and applied pressure measurementDiagnostic test
Measurement of median nerve strain and applied pressure at proximal carpal tunnel level
| Study group | Role | What they receive |
|---|---|---|
| Carpal tunnel syndrome | group of carpal tunnel syndrome patients Receives: Diagnostic Test: strain and applied pressure measurement | |
| Control group | group of healthy controls Receives: Diagnostic Test: strain and applied pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
median nerve strain
Change of the median nerve strain from the initial measurement at 3, 6, 12 months after the treatment
Measured: through study completion, an average of 1 year
applied pressure
Change of the applied pressure from the inital measurement at 3, 6, 12months after the treatment
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start3 Apr 2015
- Primary completion17 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokyo Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuichi Yoshii, Tokyo Medical University
- Investigators
- Yuichi Yoshii, Principal investigator, Tokyo Medical University Ibaraki Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027998
- Sponsor's protocol ID
- 14-5
- Status last verified
- Apr 2022
- First submitted
- 17 Jul 2019
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yoshii Y, Tung WL, Yuine H, Ishii T. Postoperative diagnostic potentials of median nerve strain and applied pressure measurement after carpal tunnel release. BMC Musculoskelet Disord. 2020 Jan 11;21(1):22. doi: 10.1186/s12891-019-3033-y.
PubMed 31926552
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Median Nerve Strain and Applied Pressure Measurement in the Carpal Tunnel Syndrome Patients
- ClinicalTrials.gov ID
- NCT04027998
- Acronym / sponsor ID
- 14-5
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tokyo Medical UniversityUniversity, hospital or other
- Study start
- 3 Apr 2015 (actual)
- Primary completion
- 17 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Jul 2019 (actual)
- 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.
The aim of this study is to investigate diagnostic accuracy of median nerve strain and applied pressure measurement . Idiopathic carpal tunnel syndrome patients and healthy controls will be evaluated by ultrasound. Median nerve strain, pressure applied to the skin will be measured at the proximal part of the carpal tunnel. The parameters will be compared between patients and controls, and before and after the open carpal tunnel release in the patients.
Detailed description
The aim of this study is to investigate diagnostic accuracy of median nerve strain and applied pressure measurement . Idiopathic carpal tunnel syndrome patients and healthy controls will be evaluated by ultrasound. Median nerve strain, pressure applied to the skin, and ratio of pressure-strain will be measured at the proximal part of the carpal tunnel. In addition, distal latencies in the motor and sensory nerve conductions studies and cross-sectional area of median nerve will be measured. The parameters will be compared between patients and controls, and before and after the open carpal tunnel release in the patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carpal tunnel syndrome | – | Diagnostic Test: strain and applied pressure measurementgroup of carpal tunnel syndrome patients |
| Control group | – | Diagnostic Test: strain and applied pressure measurementgroup of healthy controls |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- carpal tunnel syndrome patients and asymptomatic control
Key inclusion criteria (1 listed)
- carpal tunnel syndrome patients and asymptomatic control
Key exclusion criteria (1 listed)
- Patients were excluded if there was a history of cervical radiculopathy, rheumatoid arthritis, gout, hemodialysis, sarcoidosis, amyloidosis, or traumatic injuries to the arm. Written consent was obtained from all study participants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| strain and applied pressure measurementMeasurement of median nerve strain and applied pressure at proximal carpal tunnel level | Diagnostic test | Carpal tunnel syndrome, Control group |
Primary outcome
median nerve strain
Time frame: through study completion, an average of 1 year
Change of the median nerve strain from the initial measurement at 3, 6, 12 months after the treatment
applied pressure
Time frame: through study completion, an average of 1 year
Change of the applied pressure from the inital measurement at 3, 6, 12months after the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Derived from this study: PubMed 31926552Yoshii Y, Tung WL, Yuine H, Ishii T. Postoperative diagnostic potentials of median nerve strain and applied pressure measurement after carpal tunnel release. BMC Musculoskelet Disord. 2020 Jan 11;21(1):22. doi: 10.1186/s12891-019-3033-y.
- Individual participant dataSharing planned: No
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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.
Yuichi Yoshii principal investigator
Tokyo Medical University Ibaraki Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel Syndrome, run by Tokyo Medical University at 1 site in Japan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuichi Yoshii (81298871161 ext. 81298871161, yy12721@yahoo.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
median nerve strain (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 NCT04027998, 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 27 Apr 2022.