Standardization of Quantitative Muscle Ultrasonographic Parameters Among Egyptian Population

• Sponsor: Assiut University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05200780
• Collaborator: (none)
• Enrollment: 100
• Anticipated Duration (Months): 12

Study Details

Study Description

Brief 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.

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.

Condition or Disease	Intervention/Treatment	Phase
Muscle Disease	Device: ultrasound

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

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Standardization of Quantitative Muscle Ultrasonographic Parameters Among Egyptian Population
• Anticipated Study Start Date: Feb 1, 2022
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Feb 1, 2023

Outcome Measures

Primary Outcome Measures

1. get a refrence for ultrasonographic parameters muscle [10 months]

   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.

Secondary Outcome Measures

1. detect early pathological changes in muscles [8 months]

   Ultrasonography give pathophysiological insights and substantially added to diagnostic accuracy and treatment decisions amongst myopathies

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Healthy subjects were recruited amongst colleagues and family members of the researchers

2. Age group (5-70)years

3. Male and female.

Exclusion Criteria:

1. Patient refuse to participate

2. The anatomy is altered due to sever trauma,tumor,or surgery

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assiut University

Investigators

• Principal Investigator: Ghaydaa Ahmed shehata, prof, medical service affiliation

Study Documents (Full-Text)

None provided.

More Information

Publications

• Arts 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.
• 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.
• Pillen 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.
• Pillen 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. Epub 2007 May 29.
• Reimers 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. Review.
• Walker FO, Cartwright MS, Wiesler ER, Caress J. Ultrasound of nerve and muscle. Clin Neurophysiol. 2004 Mar;115(3):495-507. Review.

• Responsible Party: Doaa Soliman Abd elhafeez, Standardization of quantitative muscle ultrasonographic parameters among Egyptian population, Assiut University
• ClinicalTrials.gov Identifier: NCT05200780
• Other Study ID Numbers: muscle ultrasonography
• First Posted: Jan 21, 2022
• Last Update Posted: Jan 21, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Muscular Diseases

Study Results

No Results Posted as of Jan 21, 2022