Carpal Tunnel SyndromeNCT04092140
Neuromuscular Ultrasound in Correlation to Neurophysiological Findings
An observational study of Carpal Tunnel Syndrome and Diabetic Neuropathies, run by Assiut University.
Trial summary
1. Study the neuromuscular ultrasound findings in different types of neuropathies 2. correlation between ultrasound and neurophysiological findings in peripheral nerve diseases 3. correlation between clinical pain scale and severity of neuropathy Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome, Diabetic Neuropathies, Guillain-Barre Syndrome
- What is being tested?
- ultrasound
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to Nov 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Setting:in assuit university hospitals, neuropsychiatry hospital,neurology, orthopedic ,and internal medicine outpatients clinics subjects:will include two groups : peripheral nerve diseases group and healthy control group
Who may be able to join
- above 18 years old
- males or females
- diabetic complaining of neuropathy or not
- carpal tunnel syndrome
- Guillain-Barré syndrome
Who cannot join
- Patient refuse to participate
- The anatomy is altered due to sever trauma,tumor,or surgery
- Severe spasticity preventing examination
About this study
Official title: Neuromuscular Ultrasound Changes in Neuropathies in Correlation to Neurophysiological Findings
- Study the neuromuscular ultrasound findings in different types of neuropathies
- correlation between ultrasound and neurophysiological findings in peripheral nerve diseases
- correlation between clinical pain scale and severity of neuropathy
Read the detailed description
Ultrasonography is a diagnostic tool that is increasingly used in the work-up of peripheral nerve disease.
As many peripheral nerves run a superficial course, especially in the arms. This is a big advantage over Magnetic Resonance Imaging that is relatively expensive, time consuming and not readily available everywhere.
Nerve cross-sectional area (CSA) can be determined at multiple sites along the nerve.
CSA can be measured at entrapment sites but also at nonentrapment sites. vascularization, echogenicity, fascicular pattern and endoneurial thickness can be investigated as well. All those modalities can give critical insight in the origin and development of various peripheral neuropathies1,2,3
Major peripheral nerves in the extremities, such as the median,ulnar thick enough to reflect the sound beam, resulting in hyperechoic on the US scan 4.
The correlation between nerve conduction study parameters and CSA in ultrasound Ultrasound of the peripheral nervous system is an additional useful diagnostic tool in neuromuscular disorders..5,6,7,8,9 In the longitudinal plane, nerves present as long, slim structures with a mixture of parallel hypoechoic and hyperechoic lines.
Nerves must be distinguished from other nearby structures to ensure correct identification Muscles are hypoechoic and interspersed with small hyperechoic foci which easily distinguishes muscles from nerves. Tendons, which are sometimes adjacent to nerves, move proportionately with joint movement.
US has higher specificity than sensitivity in differentiating myopathic and neuropathic changes The most sensitive diagnostic marker for symptomatic carpal tunnel syndrome patients is an enlarged crosssectional area of the median nerve 10,11,12
- Being tested
- ultrasound
- Medical subject headings
- Carpal Tunnel Syndrome, Diabetic Neuropathies, Guillain-Barre Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDevice
Also called ultrasonography
easy new non invasive tool
| Study group | Role | What they receive |
|---|---|---|
| diabetic complaining of neuropathy or not | using of ultrasound in examination and nerve conduction study Receives: Device: ultrasound | |
| carpal tunnel syndrome | using of ultrasound in examination and nerve conduction study Receives: Device: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nerve ultrasound
on median and ulnar nerves
Measured: 3 years
muscle Ultrasound
on thenar and hypothenar muscles
Measured: 3 years
nerve conduction studies
for median and ulnar nerves (sensory and motor)
Measured: 3 years
Electromyogram
for thenar and hypothenar
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start1 Oct 2019 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionNov 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 Assiut 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahera Sayed Ahmed Abd El Maged, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092140
- Sponsor's protocol ID
- ultrasound in neuropathies
- Status last verified
- Sep 2019
- First submitted
- 14 Sep 2019
- Last updated
- 19 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Ultrasound Changes in Neuropathies in Correlation to Neurophysiological Findings
- ClinicalTrials.gov ID
- NCT04092140
- Acronym / sponsor ID
- ultrasound in neuropathies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 17 Sep 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.
- Study the neuromuscular ultrasound findings in different types of neuropathies
- correlation between ultrasound and neurophysiological findings in peripheral nerve diseases
- correlation between clinical pain scale and severity of neuropathy
Detailed description
Ultrasonography is a diagnostic tool that is increasingly used in the work-up of peripheral nerve disease.
As many peripheral nerves run a superficial course, especially in the arms. This is a big advantage over Magnetic Resonance Imaging that is relatively expensive, time consuming and not readily available everywhere.
Nerve cross-sectional area (CSA) can be determined at multiple sites along the nerve.
CSA can be measured at entrapment sites but also at nonentrapment sites. vascularization, echogenicity, fascicular pattern and endoneurial thickness can be investigated as well. All those modalities can give critical insight in the origin and development of various peripheral neuropathies1,2,3
Major peripheral nerves in the extremities, such as the median,ulnar thick enough to reflect the sound beam, resulting in hyperechoic on the US scan 4.
The correlation between nerve conduction study parameters and CSA in ultrasound Ultrasound of the peripheral nervous system is an additional useful diagnostic tool in neuromuscular disorders..5,6,7,8,9 In the longitudinal plane, nerves present as long, slim structures with a mixture of parallel hypoechoic and hyperechoic lines.
Nerves must be distinguished from other nearby structures to ensure correct identification Muscles are hypoechoic and interspersed with small hyperechoic foci which easily distinguishes muscles from nerves. Tendons, which are sometimes adjacent to nerves, move proportionately with joint movement.
US has higher specificity than sensitivity in differentiating myopathic and neuropathic changes The most sensitive diagnostic marker for symptomatic carpal tunnel syndrome patients is an enlarged crosssectional area of the median nerve 10,11,12
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diabetic complaining of neuropathy or not | – | Device: ultrasoundusing of ultrasound in examination and nerve conduction study |
| carpal tunnel syndrome | – | Device: ultrasoundusing of ultrasound in examination and nerve conduction study |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Setting:in assuit university hospitals, neuropsychiatry hospital,neurology, orthopedic ,and internal medicine outpatients clinics subjects:will include two groups : peripheral nerve diseases group and healthy control group
Key inclusion criteria (5 listed)
- above 18 years old
- males or females
- diabetic complaining of neuropathy or not
- carpal tunnel syndrome
- Guillain-Barré syndrome
Key exclusion criteria (3 listed)
- Patient refuse to participate
- The anatomy is altered due to sever trauma,tumor,or surgery
- Severe spasticity preventing examination
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 |
|---|---|---|
| ultrasoundAlso: ultrasonographyeasy new non invasive tool | Device | carpal tunnel syndrome, diabetic complaining of neuropathy or not |
Primary outcome
Nerve ultrasound
Time frame: 3 years
on median and ulnar nerves
muscle Ultrasound
Time frame: 3 years
on thenar and hypothenar muscles
nerve conduction studies
Time frame: 3 years
for median and ulnar nerves (sensory and motor)
Electromyogram
Time frame: 3 years
for thenar and hypothenar
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
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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 Carpal Tunnel Syndrome and Diabetic Neuropathies, run by Assiut 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 5 inclusion and 3 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 19 Sep 2019. 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?
Results are not available in the source record.
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?
Nerve ultrasound (time frame: 3 years). The study lists 4 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 19 Sep 2019.