UltrasonographyNCT06834061
Added Value of Ultrasonography in the Diagnosis, Management, and Follow-Up of Carpal Tunnel Syndrome
An observational study of Ultrasonography and Diagnosis, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
This study aims to assess the ultrasound (US) and nerve conduction studies (NCS) as a tool for diagnosis, treatment planning and follow-up of patients with carpal tunnel syndrome (CTS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ultrasonography, Diagnosis, Management
- What is being tested?
- Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Feb 2025to 1 Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This retrospective study will be carried out on 60 patients with CTS admitted in KafrElsheikh University Hospitals over a period of 6 months starting from approval of the Medical Sciences Ethics Committee of KafrElsheikh Faculty of Medicine and all the included patients will provide written informed consent.
Who may be able to join
- Age ≥18 years old.
- Both sexes.
- Patients with carpal tunnel syndrome.
Who cannot join
- History of wrist surgery (including carpal tunnel injection) or fracture.
- Clinical or electrophysiological evidence of an accompanying condition that mimics carpal tunnel syndrome or interferes with its evaluation, such as proximal median neuropathy, cervical radiculopathy or polyneuropathy.
- History of underlying disorders associated with carpal tunnel syndrome such as diabetes mellitus, rheumatoid arthritis, pregnancy, acromegaly or hypothyroidism.
- Electrodiagnostic findings suggestive of co-existing neurological disorders.
- Subclinical sensory polyneuropathy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Kafrelsheikh University
Kafr ash Shaykh, Kafrelsheikh, 33516
Ahmed A Zahra, MD, 00201004642184, a86anas@gmail.com
About this study
This study aims to assess the ultrasound (US) and nerve conduction studies (NCS) as a tool for diagnosis, treatment planning and follow-up of patients with carpal tunnel syndrome (CTS).
Read the detailed description
Carpal tunnel syndrome (CTS) is one of the most common upper extremity compression neuropathies and is caused by compression of the median nerve in the carpal tunnel at the wrist.
The ultrasound (US) is a follow-up option as a diagnostic tool in CTS. It is a readily available non-invasive tool which has a shorter examination time. It can measure a number of median nerve parameters, including size, vascularity (using power Doppler) and mobility (using dynamic imaging). In addition,the US provides information on anatomical variations of the median nerve and surrounding structures that may be a causative factor in CTS.
- Conditions
- Ultrasonography, Diagnosis, Management, Follow-Up, Carpal Tunnel Syndrome
- Being tested
- Ultrasound
- Medical subject headings
- Disease, Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundProcedure or surgery
All patients underwent high-resolution real-time sonography of the carpal tunnel (both hands) using an Ultrasound (US) machine and a 12 MHz linear array transducer. US examination will be performed before and 3 months after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound group | All patients underwent high-resolution real-time sonography of the carpal tunnel (both hands) using an Ultrasound (US) machine and a 12 MHz linear array transducer. US examination will be performed before and 3 months after surgery. Receives: Procedure: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of ultrasound in diagnosis of carpal tunnel syndrome
Sensitivity of ultrasound in diagnosis of carpal tunnel syndrome will be recorded.
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start19 Feb 2025
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasonographyStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Anas Zahra, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834061
- Sponsor's protocol ID
- KFSIRB200-513
- Status last verified
- Feb 2025
- First submitted
- 13 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Added Value of Ultrasonography in the Diagnosis, Management, and Follow-Up of Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT06834061
- Acronym / sponsor ID
- KFSIRB200-513
- Conditions
- Ultrasonography, Diagnosis, Management, Follow-Up, Carpal Tunnel Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 19 Feb 2025 (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 study aims to assess the ultrasound (US) and nerve conduction studies (NCS) as a tool for diagnosis, treatment planning and follow-up of patients with carpal tunnel syndrome (CTS).
Detailed description
Carpal tunnel syndrome (CTS) is one of the most common upper extremity compression neuropathies and is caused by compression of the median nerve in the carpal tunnel at the wrist.
The ultrasound (US) is a follow-up option as a diagnostic tool in CTS. It is a readily available non-invasive tool which has a shorter examination time. It can measure a number of median nerve parameters, including size, vascularity (using power Doppler) and mobility (using dynamic imaging). In addition,the US provides information on anatomical variations of the median nerve and surrounding structures that may be a causative factor in CTS.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound group | – | Procedure: UltrasoundAll patients underwent high-resolution real-time sonography of the carpal tunnel (both hands) using an Ultrasound (US) machine and a 12 MHz linear array transducer. US examination will be performed before and 3 months after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective study will be carried out on 60 patients with CTS admitted in KafrElsheikh University Hospitals over a period of 6 months starting from approval of the Medical Sciences Ethics Committee of KafrElsheikh Faculty of Medicine and all the included patients will provide written informed consent.
Key inclusion criteria (3 listed)
- Age ≥18 years old.
- Both sexes.
- Patients with carpal tunnel syndrome.
Key exclusion criteria (5 listed)
- History of wrist surgery (including carpal tunnel injection) or fracture.
- Clinical or electrophysiological evidence of an accompanying condition that mimics carpal tunnel syndrome or interferes with its evaluation, such as proximal median neuropathy, cervical radiculopathy or polyneuropathy.
- History of underlying disorders associated with carpal tunnel syndrome such as diabetes mellitus, rheumatoid arthritis, pregnancy, acromegaly or hypothyroidism.
- Electrodiagnostic findings suggestive of co-existing neurological disorders.
- Subclinical sensory polyneuropathy.
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 |
|---|---|---|
| UltrasoundAll patients underwent high-resolution real-time sonography of the carpal tunnel (both hands) using an Ultrasound (US) machine and a 12 MHz linear array transducer. US examination will be performed before and 3 months after surgery. | Procedure or surgery | Ultrasound group |
Primary outcome
Sensitivity of ultrasound in diagnosis of carpal tunnel syndrome
Time frame: Intraoperatively
Sensitivity of ultrasound in diagnosis of carpal tunnel syndrome will be recorded.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
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 Ultrasonography and Diagnosis, run by Kafrelsheikh 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 3 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: looking for participants now, as of the sponsor's last update on 20 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Zahra, MD (00201004642184, a86anas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of ultrasound in diagnosis of carpal tunnel syndrome (time frame: Intraoperatively). 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 20 Feb 2025.