NCT04233255|Completed
Role of Ultrasound in Diagnosis of Muscle Diseases
The Role of Neuromuscular Ultrasound in Diagnosis of Muscle Diseases
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The Role of Neuromuscular Ultrasound in Diagnosis of Muscle Diseases
Sponsor study identifier
observational
128
1 country
1
Study Start
April 1, 2020
Actual (reported)Primary Completion
April 4, 2024
Actual (reported)Study Completion
July 1, 2024
Actual (reported)The study aims to provide a timely update on the role of combining clinical and neuromuscular ultrasound assessments in diagnosis and follow-up of various muscle diseases in clinical practice over 12 months period, and correlating US findings with functional scales, biochemical and electrophysiological studies.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 15, 2020
Actual (reported)January 18, 2020
Actual (reported)April 1, 2020
Actual (reported)April 4, 2024
Actual (reported)July 1, 2024
Actual (reported)The rate of decline of patients with muscle disorder versus normal subjects as assessed by quantitative ultrasound measurements and electrophysiology studies.
With the successful completion of this aim, the investigators will establish that alterations in both quantitative ultrasound and electromyography will provide meaningful measures of disease progression.
up to 12 months
Rate of change in Functional assessment of muscle weakness
up to 12 months
Rate of change in manual muscle strength testing by EXPANDED MRC (The modified Medical Research Council)
up to 12 months
Rate of change of serum CPK and CK-MM levels
up to 12 months
Includes 64 symptomatic patients with muscle disease subdivided into two subgroups (a) 10 patients with acute inflammatory myositis; And (b 545patients with hereditary myopathy. The patients will be subjected to neuromuscular ultrasound (US) and electrophysiology at baseline,after 6 months and after 12 months. The number and location of studied muscles will be determined according to pattern of clinical presentation.
Includes 64 healthy volunteers as control group. They will be subjected to neuromuscular ultrasound (US) and electrophysiology at baseline. Their age, sex, number and location of studied muscles will be matched with patients' group.
Quantitative ultrasound measurements will be performed to studied muscles according to a standard protocol; for each muscle three consecutive measurements will be made to minimize variation in echo intensity during analysis .The captured images will be analyzed offline for echo intensity by means of computer-assisted grayscale histogram analysis.The study will be performed using My lab 7 ultrasound system (Esaote company, Italy) that is equipped by 7-19 MHz linear array transducer and color and power Doppler. Technique: evaluation of studied muscles for echo intensity (ECHO), quantitative assessments of echointensity, muscle perfusion, transverse and longitudinal sections of the muscle and its thickness at rest and during maximal voluntary contractions (MVC), overlying subcutaneous fat, cross-sectional area (CSA), and angled fibers of pennate muscles.
The study will be performed on 2 groups Group (I): 32 patients diagnosed to have muscle disease subdivided into two subgroups (a)16 patients with acute inflammatory myositis; And (b)16 patients with hereditary myopathy. Group (II): including 32 healthy volunteers matching age and sex as control group.
Assiut University Hospital
Asyut, Egypt
Wattjes MP, Kley RA, Fischer D. Neuromuscular imaging in inherited muscle diseases. Eur Radiol. 2010 Oct;20(10):2447-60. doi: 10.1007/s00330-010-1799-2. Epub 2010 Apr 27.
Boon A. Ultrasonography and electrodiagnosis: are they complementary techniques? PM R. 2013 May;5(5 Suppl):S100-6. doi: 10.1016/j.pmrj.2013.03.014. Epub 2013 Mar 19.
Chiaramonte R, Bonfiglio M, Castorina EG, Antoci SAM. The primacy of ultrasound in the assessment of muscle architecture: precision, accuracy, reliability of ultrasonography. Physiatrist, radiologist, general internist, and family practitioner's experiences. Rev Assoc Med Bras (1992). 2019 Feb;65(2):165-170. doi: 10.1590/1806-9282.65.2.165.
Nageh F. El-Gammal, Doctorate
Assiut University
128 participants (actual enrollment reported by the registry).
First Submitted
January 15, 2020
First Posted
January 18, 2020
Study Start
April 1, 2020
Actual (reported)Point-of-Care Ultrasound in Primary Care
Includes: Motor and sensory nerve conduction study, F-wave and H-reflex study to assess the proximal roots, Electromyography (EMG) of the studied muscles. using machine: recordings will be performed with a Nihon Kohden equipment (model 7102) with the following parameters: sweep time 8 ms/D, sensitivity 0.5 mV/D, low frequency filter 2 Hz, high frequency filter 10 kHz, stimulation duration 0.1 ms and stimulation frequency 1 Hz.
measured in U/L using ELISA.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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O'Sullivan PJ, Gorman GM, Hardiman OM, Farrell MJ, Logan PM. Sonographically guided percutaneous muscle biopsy in diagnosis of neuromuscular disease: a useful alternative to open surgical biopsy. J Ultrasound Med. 2006 Jan;25(1):1-6. doi: 10.7863/jum.2006.25.1.1.
Kubinova K, Dejthevaporn R, Mann H, Machado PM, Vencovsky J. The role of imaging in evaluating patients with idiopathic inflammatory myopathies. Clin Exp Rheumatol. 2018 Sep-Oct;36 Suppl 114(5):74-81. Epub 2018 Oct 1.
Mah JK, van Alfen N. Neuromuscular Ultrasound: Clinical Applications and Diagnostic Values. Can J Neurol Sci. 2018 Nov;45(6):605-619. doi: 10.1017/cjn.2018.314.
Barohn RJ, Dimachkie MM, Jackson CE. A pattern recognition approach to patients with a suspected myopathy. Neurol Clin. 2014 Aug;32(3):569-93, vii. doi: 10.1016/j.ncl.2014.04.008.
Vanhoutte EK, Faber CG, van Nes SI, Jacobs BC, van Doorn PA, van Koningsveld R, Cornblath DR, van der Kooi AJ, Cats EA, van den Berg LH, Notermans NC, van der Pol WL, Hermans MC, van der Beek NA, Gorson KC, Eurelings M, Engelsman J, Boot H, Meijer RJ, Lauria G, Tennant A, Merkies IS; PeriNomS Study Group. Modifying the Medical Research Council grading system through Rasch analyses. Brain. 2012 May;135(Pt 5):1639-49. doi: 10.1093/brain/awr318. Epub 2011 Dec 20.
Primary Completion
April 4, 2024
Actual (reported)Study Completion
July 1, 2024
Actual (reported)Last Updated
February 25, 2025
Record last verified: 2025-02
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