Carpal Tunnel SyndromeNCT04976998
Role of Ultrasonography in the Diagnosis of Carpal Tunnel Syndrome
An observational study of Carpal Tunnel Syndrome, run by Sohag University at 1 site in Egypt.
Trial summary
This prospective study aims to evaluate the median nerve in Carpal Tunnel Syndrome by high-frequency ultrasound and color Doppler in comparison with clinical and Nerve conduction studies. 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?
- imaging
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Aug 2021to 20 Mar 2022
- 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: sohag university hospital patients and attendants
Who may be able to join
- Any Age Group with symptoms, clinical signs and NCS consistent with CTS
Who cannot join
- Uncooperative Patients .
- Patients with History of previous wrist surgery, fracture or traumatic nerve injury
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University - Faculty of Medicine
Sohag, 82524
mostafa ahmed, 01095529721, fikry.1034@yahoo.com
About this study
Official title: Role of Ultrasonography in the Diagnosis of Carpal Tunnel Syndrome and Detection of Its Severity
This prospective study aims to evaluate the median nerve in Carpal Tunnel Syndrome by high-frequency ultrasound and color Doppler in comparison with clinical and Nerve conduction studies.
Read the detailed description
This prospective study aims to evaluate the median nerve anatomical changes in Carpal Tunnel Syndrome by high-frequency ultrasound and color Doppler in comparison with clinical and Nerve conduction studies physiological changes to determine the efficacy of ultrasound to diagnose and determine the severity of carpal tunnel syndrome.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- imaging
- 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.
imagingDiagnostic test
Also called nerve conduction studies
imaging by ultrasonography and nerve conduction studies will be done for both grups
| Study group | Role | What they receive |
|---|---|---|
| patients | those with symptoms of CTS Receives: Diagnostic Test: imaging | |
| control group | normal people those with no symptoms of CTS Receives: Diagnostic Test: imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
anatomical changes in the median nerve in carpal tunnel syndrome
compare the anatomical changes observed by ultrasonography in patients diagnosed with carpal tunnel syndrome and comparing the results with clinical and nerve conduction studies results
Measured: imaging within 24 hours from the nerve conduction studies and clinical assessment of the patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start29 Aug 2021 (estimated)
- Primary completion2 Feb 2022 (estimated)
- Study completion20 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Ahmed Mohamed, Sohag University
- Investigators
- mostafa mm mohamed, MBBCH, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976998
- Sponsor's protocol ID
- Soh-Med-21-07-17
- Status last verified
- Aug 2021
- First submitted
- 15 Jul 2021
- Last updated
- 17 Aug 2021
- Results posted
- No
- 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 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Ultrasonography in the Diagnosis of Carpal Tunnel Syndrome and Detection of Its Severity
- ClinicalTrials.gov ID
- NCT04976998
- Acronym / sponsor ID
- Soh-Med-21-07-17
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 29 Aug 2021 (estimated)
- Primary completion
- 2 Feb 2022 (estimated)
- Study completion
- 20 Mar 2022 (estimated)
- First posted
- 26 Jul 2021 (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.
This prospective study aims to evaluate the median nerve in Carpal Tunnel Syndrome by high-frequency ultrasound and color Doppler in comparison with clinical and Nerve conduction studies.
Detailed description
This prospective study aims to evaluate the median nerve anatomical changes in Carpal Tunnel Syndrome by high-frequency ultrasound and color Doppler in comparison with clinical and Nerve conduction studies physiological changes to determine the efficacy of ultrasound to diagnose and determine the severity of carpal tunnel syndrome.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients | – | Diagnostic Test: imagingthose with symptoms of CTS |
| control group | – | Diagnostic Test: imagingnormal people those with no symptoms of CTS |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- sohag university hospital patients and attendants
Key inclusion criteria (1 listed)
- Any Age Group with symptoms, clinical signs and NCS consistent with CTS
Key exclusion criteria (2 listed)
- Uncooperative Patients .
- Patients with History of previous wrist surgery, fracture or traumatic nerve injury
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 |
|---|---|---|
| imagingAlso: nerve conduction studiesimaging by ultrasonography and nerve conduction studies will be done for both grups | Diagnostic test | control group, patients |
Primary outcome
anatomical changes in the median nerve in carpal tunnel syndrome
Time frame: imaging within 24 hours from the nerve conduction studies and clinical assessment of the patient
compare the anatomical changes observed by ultrasonography in patients diagnosed with carpal tunnel syndrome and comparing the results with clinical and nerve conduction studies results
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- 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.
mostafa mm mohamed, MBBCH principal investigator
Sohag University
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 Sohag University at 1 site in Egypt.
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 2 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 17 Aug 2021. 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 Egypt. 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 Mostafa mm Mohamed, MBBCh (01095529721 ext. +20, mostafa011187@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anatomical changes in the median nerve in carpal tunnel syndrome (time frame: imaging within 24 hours from the nerve conduction studies and clinical assessment of the patient). 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 Aug 2021.