Standardization of Quantitative Muscle Ultrasonographic Parameters Among Egyptian Population

Muscle Disease Clinical Trial

Official title:

Standardization of Quantitative Muscle Ultrasonographic Parameters Among Egyptian Population

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05200780
• Other study ID #: muscle ultrasonography
• Status: Not yet recruiting
• Start date: February 1, 2022
• Est. completion date: February 2023

Study information

• Verified date: January 2022
• Source: Assiut University
• Contact: doaa soliman abdelhafeez
• Phone: 01033427347
• Email: doaasoliman133555[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Disease
• Muscular Diseases

Intervention

Device:
• ultrasound
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Walker FO, Cartwright MS, Wiesler ER, Caress J. Ultrasound of nerve and muscle. Clin Neurophysiol. 2004 Mar;115(3):495-507. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 months
Secondary	detect early pathological changes in muscles	Ultrasonography give pathophysiological insights and substantially added to diagnostic accuracy and treatment decisions amongst myopathies	8 months