Clinical trial NCT05200780: Standardization of Quantitative Muscle Ultrasonographic Parameters Among Egyptian Population
Official title: Standardization of Quantitative Muscle Ultrasonographic Parameters Among Egyptian Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Muscle Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: get a refrence for ultrasonographic parameters muscle
timeFrame: 10 months
Secondary outcomes:
measure: detect early pathological changes in muscles
timeFrame: 8 months
Other outcomes:
Locations:
Study officials:
affiliation: medical service affiliation
name: Ghaydaa Ahmed shehata, prof
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/s0140-6736(80)92656-2.
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. doi: 10.1016/s0022-510x(96)00037-8.
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. doi: 10.1016/j.nmd.2007.03.008. Epub 2007 May 29.
citation: 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.
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. doi: 10.1016/j.ultrasmedbio.2006.05.028.
citation: 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.