Standardization of Quantitative Muscle Ultrasonographic Parameters Among Egyptian Population

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Muscle Disease
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: doaa soliman abdelhafeez; Phone Number: 01033427347; Email: doaasoliman133555@gmail.com
• Study Contact Backup: Name: Khaled Osama Mohamed, Ass .prof; Phone Number: 01003012229; Email: Khalednao26@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 66 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
detect early pathological changes in muscles	Ultrasonography give pathophysiological insights and substantially added to diagnostic accuracy and treatment decisions amongst myopathies	8 months

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Ghaydaa Ahmed shehata, prof, medical service affiliation

Publications and helpful links

General 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.
• 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. doi: 10.1016/s0022-510x(96)00037-8.
• 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. doi: 10.1016/j.nmd.2007.03.008. Epub 2007 May 29.
• Walker 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.
• 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. doi: 10.1016/j.ultrasmedbio.2006.05.028.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2022
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: January 1, 2022
• First Submitted That Met QC Criteria: January 14, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Actual): January 21, 2022
• Last Update Submitted That Met QC Criteria: January 14, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Muscular Diseases
• Other Study ID Numbers: muscle ultrasonography

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No