CTSNCT03082027
Pre-operative Sonographic Assessment of The Median Nerve in Carpal Tunnel Syndrome. Does it Affect The Operative Procedure?
An observational study of CTS, run by Minia University.
Trial summary
Sonographic Assessment of The Median Nerve in Carpal Tunnel Syndrome to assess the surgical importance and added value of superficial ultrasonography in assessment of the median nerve in CTS. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- CTS
- What is being tested?
- ultrasonography
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 1 Mar 2017
- 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: Thirty patients diagnosed as CTS were referred from the orthopedic clinics Another thirty healthy asymptomatic persons were included in this study as a control group
Who may be able to join
- Carpal tunnel syndrome
Who cannot join
- bifid median nerve, carpal tunnel mass lesions, persistent median artery
About this study
Sonographic Assessment of The Median Nerve in Carpal Tunnel Syndrome to assess the surgical importance and added value of superficial ultrasonography in assessment of the median nerve in CTS.
Read the detailed description
Abstract Objective: To assess the surgical importance and added value of superficial ultrasonography in assessment of the median nerve in CTS.
Methods: The study was conducted on thirty patients with CTS with electrophysiological confirmation; twelve males and eighteen females with mean age 43.93±4.51 (range 35-52y), and another thirty normal subjects; fifteen males and fifteen females, with their mean age 36.7±4.86 (range 29-45y). The cross sectional area (CSA) and flattening ratio (FR) at different levels were measured on both groups. Data from the study and control groups were compared. The accuracy of the ultrasonographic diagnostic criteria for CTS was evaluated using receiver operating characteristic (ROC) analysis. All the patients had surgical carpal tunnel release and the operative details were correlated with the ultrasonographic data.
- Conditions
- CTS
- Being tested
- ultrasonography
- Keywords
- ultrasonography, carpal tunnel syndrome
- 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.
ultrasonographyDiagnostic test
ultrasonography of median nerve
| Study group | Role | What they receive |
|---|---|---|
| ultrasonography | diagnostic tool Receives: Diagnostic Test: ultrasonography | |
| operative release | Not described Receives: Diagnostic Test: ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
cross sectional area
Measured: three minutes
flattening ratio
Measured: three minutes
Secondary outcomes (1)
cross sectional area difference
Measured: three minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start1 Apr 2016
- Primary completion31 Dec 2016
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CTSStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Allam, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082027
- Sponsor's protocol ID
- Minia university
- Status last verified
- Mar 2017
- First submitted
- 7 Mar 2017
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-operative Sonographic Assessment of The Median Nerve in Carpal Tunnel Syndrome. Does it Affect The Operative Procedure?
- ClinicalTrials.gov ID
- NCT03082027
- Acronym / sponsor ID
- Minia university
- Conditions
- CTS
- Keywords
- ultrasonography, carpal tunnel syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 17 Mar 2017 (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.
Sonographic Assessment of The Median Nerve in Carpal Tunnel Syndrome to assess the surgical importance and added value of superficial ultrasonography in assessment of the median nerve in CTS.
Detailed description
Abstract Objective: To assess the surgical importance and added value of superficial ultrasonography in assessment of the median nerve in CTS.
Methods: The study was conducted on thirty patients with CTS with electrophysiological confirmation; twelve males and eighteen females with mean age 43.93±4.51 (range 35-52y), and another thirty normal subjects; fifteen males and fifteen females, with their mean age 36.7±4.86 (range 29-45y). The cross sectional area (CSA) and flattening ratio (FR) at different levels were measured on both groups. Data from the study and control groups were compared. The accuracy of the ultrasonographic diagnostic criteria for CTS was evaluated using receiver operating characteristic (ROC) analysis. All the patients had surgical carpal tunnel release and the operative details were correlated with the ultrasonographic data.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasonography | – | Diagnostic Test: ultrasonographydiagnostic tool |
| operative release | – | Diagnostic Test: ultrasonography |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Thirty patients diagnosed as CTS were referred from the orthopedic clinics Another thirty healthy asymptomatic persons were included in this study as a control group
Key inclusion criteria (1 listed)
- Carpal tunnel syndrome
Key exclusion criteria (1 listed)
- bifid median nerve, carpal tunnel mass lesions, persistent median artery
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 |
|---|---|---|
| ultrasonographyultrasonography of median nerve | Diagnostic test | operative release, ultrasonography |
Primary outcome
cross sectional area
Time frame: three minutes
flattening ratio
Time frame: three minutes
1 secondary outcome
cross sectional area difference
Time frame: three minutes
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 17 Mar 2017.
- Individual participant dataSharing planned: Undecided
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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.
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 CTS, run by Minia University.
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: finished, as of the sponsor's last update on 17 Mar 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?
cross sectional area (time frame: three minutes). 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?
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 17 Mar 2017.