Muscle DiseaseNCT05200780
Standardization of Quantitative Muscle Ultrasonographic Parameters Among Egyptian Population
An observational study of Muscle Disease, run by Assiut University.
Trial summary
1-standardization of semi quantitative muscle ultrasonographic parameters ( muscle thickness (MT) and echo intensity (EI) ) in healthy adults and to obtain a set of normal values of all accessible muscle in both upper and lower limbs. Read more about this study
- Who is it for?
- Ages 5 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Disease
- What is being tested?
- ultrasound
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2022to Feb 2023
- 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 5 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 1. Healthy subjects were recruited amongst colleagues and family members of the researchers 2. Age group (5-70)years 3. Male and female.
Who may be able to join
- Healthy subjects were recruited amongst colleagues and family members of the researchers
- Age group (5-70)years
- Male and female.
Who cannot join
- Patient refuse to participate
- The anatomy is altered due to sever trauma,tumor,or surgery
Trial locations and contacts
No sites are listed yet.
About this study
1-standardization of semi quantitative muscle ultrasonographic parameters ( muscle thickness (MT) and echo intensity (EI) ) in healthy adults and to obtain a set of normal values of all accessible muscle in both upper and lower limbs.
2.standardizaition of quantitative muscle ultrasonographic parameters (Gray scale level (GSL), Calibrated muscle backscatter values (cMBs), Optical Density (OD), 2D Textu1) in healthy adults and to obtain a set of normal values of all accessible muscle in both upper and lower limbs.
Read the detailed description
. Ultrasound is a widely used imaging technique in many different medical specialties. It is a non-invasive, safe and relatively cheap investigation method.
Ultrasound is a non-invasive method to quantitatively measure various muscle parameters.
Ultrasound imaging (US) has shown to be capable of visualizing normal and pathological skeletal muscles.(1) By measuring muscle thickness (MT) and echo intensity (EI) (=grey-value) of the muscle, structural changes caused by neuromuscular disorders can be detected. (2, 3, 4) Quantitative evaluation of US images is preferable over visual evaluation, because it is more sensitive and objective and offers the possibility to perform statistical analysis.(5) A prerequisite for the diagnostic use of quantitative muscle US is the availability of normal reference values.
Ultrasonography can detect structural muscle changes caused by neuromuscular disease. Quantitative analysis is the preferred method to determine if ultrasound findings are within normal limits, but normative data are incomplete.(6)
- Conditions
- Muscle Disease
- Being tested
- ultrasound
- Medical subject headings
- Muscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDevice
All subjects will undergo the tests with the same machine. Transverse ultrasound images were obtained using the Philips HD with a 4-12 MHz probe. in neurosonology unit in neurology department.
What is being measured
The primary outcome is the main question the study is designed to answer.
get a refrence for ultrasonographic parameters muscle
- use new, easy ,non-invasive tool "neuromuscular ultrasound"
- ultrasound give important morphological information of the muscles and can differentiate normal and diseased muscle.
1_use new, easy ,non-invasive tool "neuromuscular ultrasound" 2_ultrasound give important morphological information of the muscles and can differentiate normal and diseased muscle.1_use new, easy ,non-invasive tool "neuromuscular ultrasound" 2_ultrasound give important morphological information of the muscles and can differentiate normal and diseased muscle.
Measured: 10 months
Secondary outcomes (1)
detect early pathological changes in muscles
Ultrasonography give pathophysiological insights and substantially added to diagnostic accuracy and treatment decisions amongst myopathies
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start1 Feb 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Muscle DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Soliman Abd elhafeez, Assiut University
- Investigators
- Ghaydaa Ahmed shehata, prof, Principal investigator, medical service affiliation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200780
- Sponsor's protocol ID
- muscle ultrasonography
- Status last verified
- Jan 2022
- First submitted
- 1 Jan 2022
- Last updated
- 21 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Heckmatt JZ, Dubowitz V, Leeman S. Detection of pathological change in dystrophic muscle with B-scan ultrasound imaging. Lancet. 1980 Jun 28;1(8183):1389-90. doi: 10.1016/s0140-6736(80)92656-2.
PubMed 6104175Reimers CD, Schlotter B, Eicke BM, Witt TN. Calf enlargement in neuromuscular diseases: a quantitative ultrasound study in 350 patients and review of the literature. J Neurol Sci. 1996 Nov;143(1-2):46-56. doi: 10.1016/s0022-510x(96)00037-8.
PubMed 8981297Pillen S, Verrips A, van Alfen N, Arts IM, Sie LT, Zwarts MJ. Quantitative skeletal muscle ultrasound: diagnostic value in childhood neuromuscular disease. Neuromuscul Disord. 2007 Jul;17(7):509-16. doi: 10.1016/j.nmd.2007.03.008. Epub 2007 May 29.
PubMed 17537635Walker FO, Cartwright MS, Wiesler ER, Caress J. Ultrasound of nerve and muscle. Clin Neurophysiol. 2004 Mar;115(3):495-507. doi: 10.1016/j.clinph.2003.10.022.
PubMed 15036045Pillen S, van Keimpema M, Nievelstein RA, Verrips A, van Kruijsbergen-Raijmann W, Zwarts MJ. Skeletal muscle ultrasonography: Visual versus quantitative evaluation. Ultrasound Med Biol. 2006 Sep;32(9):1315-21. doi: 10.1016/j.ultrasmedbio.2006.05.028.
PubMed 16965971Arts IM, Pillen S, Schelhaas HJ, Overeem S, Zwarts MJ. Normal values for quantitative muscle ultrasonography in adults. Muscle Nerve. 2010 Jan;41(1):32-41. doi: 10.1002/mus.21458.
PubMed 19722256
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardization of Quantitative Muscle Ultrasonographic Parameters Among Egyptian Population
- ClinicalTrials.gov ID
- NCT05200780
- Acronym / sponsor ID
- muscle ultrasonography
- Conditions
- Muscle Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 21 Jan 2022 (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.
1-standardization of semi quantitative muscle ultrasonographic parameters ( muscle thickness (MT) and echo intensity (EI) ) in healthy adults and to obtain a set of normal values of all accessible muscle in both upper and lower limbs.
2.standardizaition of quantitative muscle ultrasonographic parameters (Gray scale level (GSL), Calibrated muscle backscatter values (cMBs), Optical Density (OD), 2D Textu1) in healthy adults and to obtain a set of normal values of all accessible muscle in both upper and lower limbs.
Detailed description
. Ultrasound is a widely used imaging technique in many different medical specialties. It is a non-invasive, safe and relatively cheap investigation method.
Ultrasound is a non-invasive method to quantitatively measure various muscle parameters.
Ultrasound imaging (US) has shown to be capable of visualizing normal and pathological skeletal muscles.(1) By measuring muscle thickness (MT) and echo intensity (EI) (=grey-value) of the muscle, structural changes caused by neuromuscular disorders can be detected. (2, 3, 4) Quantitative evaluation of US images is preferable over visual evaluation, because it is more sensitive and objective and offers the possibility to perform statistical analysis.(5) A prerequisite for the diagnostic use of quantitative muscle US is the availability of normal reference values.
Ultrasonography can detect structural muscle changes caused by neuromuscular disease. Quantitative analysis is the preferred method to determine if ultrasound findings are within normal limits, but normative data are incomplete.(6)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1. Healthy subjects were recruited amongst colleagues and family members of the researchers 2. Age group (5-70)years 3. Male and female.
Key inclusion criteria (3 listed)
- Healthy subjects were recruited amongst colleagues and family members of the researchers
- Age group (5-70)years
- Male and female.
Key exclusion criteria (2 listed)
- Patient refuse to participate
- The anatomy is altered due to sever trauma,tumor,or surgery
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 subjects will undergo the tests with the same machine. Transverse ultrasound images were obtained using the Philips HD with a 4-12 MHz probe. in neurosonology unit in neurology department. | Device | – |
Primary outcome
get a refrence for ultrasonographic parameters muscle
Time frame: 10 months
1. use new, easy ,non-invasive tool "neuromuscular ultrasound" 2. ultrasound give important morphological information of the muscles and can differentiate normal and diseased muscle. 1_use new, easy ,non-invasive tool "neuromuscular ultrasound" 2_ultrasound give important morphological information of the muscles and can differentiate normal and diseased muscle.1_use new, easy ,non-invasive tool "neuromuscular ultrasound" 2_ultrasound give important morphological information of the muscles and can differentiate normal and diseased muscle.
1 secondary outcome
detect early pathological changes in muscles
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
- Background: PubMed 6104175Heckmatt JZ, Dubowitz V, Leeman S. Detection of pathological change in dystrophic muscle with B-scan ultrasound imaging. Lancet. 1980 Jun 28;1(8183):1389-90. doi: 10.1016/s0140-6736(80)92656-2.
- Background: PubMed 8981297Reimers CD, Schlotter B, Eicke BM, Witt TN. Calf enlargement in neuromuscular diseases: a quantitative ultrasound study in 350 patients and review of the literature. J Neurol Sci. 1996 Nov;143(1-2):46-56. doi: 10.1016/s0022-510x(96)00037-8.
- Background: PubMed 17537635Pillen S, Verrips A, van Alfen N, Arts IM, Sie LT, Zwarts MJ. Quantitative skeletal muscle ultrasound: diagnostic value in childhood neuromuscular disease. Neuromuscul Disord. 2007 Jul;17(7):509-16. doi: 10.1016/j.nmd.2007.03.008. Epub 2007 May 29.
- Background: PubMed 15036045Walker FO, Cartwright MS, Wiesler ER, Caress J. Ultrasound of nerve and muscle. Clin Neurophysiol. 2004 Mar;115(3):495-507. doi: 10.1016/j.clinph.2003.10.022.
- Background: PubMed 16965971Pillen S, van Keimpema M, Nievelstein RA, Verrips A, van Kruijsbergen-Raijmann W, Zwarts MJ. Skeletal muscle ultrasonography: Visual versus quantitative evaluation. Ultrasound Med Biol. 2006 Sep;32(9):1315-21. doi: 10.1016/j.ultrasmedbio.2006.05.028.
- Background: PubMed 19722256Arts IM, Pillen S, Schelhaas HJ, Overeem S, Zwarts MJ. Normal values for quantitative muscle ultrasonography in adults. Muscle Nerve. 2010 Jan;41(1):32-41. doi: 10.1002/mus.21458.
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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.
Ghaydaa Ahmed shehata, prof principal investigator
medical service affiliation
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Disease, 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 3 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 21 Jan 2022. 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?
Contact doaa soliman abdelhafeez (01033427347, doaasoliman133555@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
get a refrence for ultrasonographic parameters muscle (time frame: 10 months). 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 NCT05200780, which also lists 6 linked publications.
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 21 Jan 2022.