Role of Ultrasound in Diagnosis of Muscle Diseases

Ultrasound Clinical Trial

Official title:

The Role of Neuromuscular Ultrasound in Diagnosis of Muscle Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04233255
• Other study ID #: RUDM
• Status: Recruiting
• Start date: April 1, 2020
• Est. completion date: July 1, 2024

Study information

• Verified date: January 2024
• Source: Assiut University
• Contact: Manar N. Abd-el-Hakim, Master
• Phone: 01024924617
• Email: mannarnasr[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Many muscle diseases share common clinical features that render arriving at appropriate diagnoses difficult. The combination of muscle imaging with clinical can limit the differential diagnosis and yield the most probable one and can direct genetic testing as the only method to arrive at a definite diagnosis.

In recent years, the use of high-resolution ultrasound had become an important tool in diagnosis and in the monitoring of disease progression and treatment of both hereditary and acquired myopathies. Additionally, it entails a safe, accessible, low-cost, and no ionizing radiation tool which renders the technique extremely suitable for paediatric patients and patients who cannot lie still without sedation. therefore, it can be used as a complementary tool to electro-diagnosis.

Ultrasound permits to evaluate echo intensity, muscle perfusion, transverse and longitudinal sections of the muscle and its thickness at rest and during maximal voluntary contractions, overlying subcutaneous fat, cross-sectional area, and angled fibers of pennate muscles.

The use of sonographically guided biopsy is an easy, safe, and reliable method for attaining tissue for histologic diagnosis in neuromuscular disease.

In most myopathies, either acute or chronic, muscle tissue undergoes morphological changes giving rise to replacement of muscle by connective tissue and/or fat. Pattern recognition on muscle imaging might be helpful in distinguishing between different disease entities.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: July 1, 2024
• Est. primary completion date: April 4, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 60 Years

Eligibility

Inclusion Criteria:

• Males and females.

• 2-60 years old.

• For patients with acute inflammatory myositis: patients presenting with characteristic picture of acute inflammatory myositis according to the myositis association 2019.

• For patients with acute inflammatory myositis: newly diagnosed patients within one month from onset of disease.

• All patients not received any previous specific treatment for myopathy.

Exclusion Criteria:

• Patients with clinically or electrophysiologically suspected other neuromuscular conditions that mimic myopathy such as motor neuron disease, neuromuscular junction disorders.

• Patients with secondary causes of myopathies; as drug induced, endocrinal disorders like diabetes mellitus and hypothyroidism or metabolic myopathy.

• Patients who received any previous specific treatment for myopathy

Related Conditions & MeSH terms

• Muscle Disease
• Muscular Diseases
• Ultrasound

Intervention

Device:
• Neuromuscular Ultrasound (US)
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.
• Electrophysiological studies
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.

Diagnostic Test:
• Seum CPK, CK-MM levels, Lactate dehydrogenase and alanine aminotransferase.
measured in U/L using ELISA.

Locations

Country	Name	City	State
Egypt	Assiut University Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (8)

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. — View Citation

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. — View Citation

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 experienc — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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, Lau — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Rate of change in Functional assessment of muscle weakness	Grading score from 0-10 according to affected muscles	up to 12 months
Secondary	Rate of change in manual muscle strength testing by EXPANDED MRC (The modified Medical Research Council)	Grading scale from 0 -5 points, measures strength of each muscle group score 0 is the weakest (worst) and 5 is the strongest (best)	up to 12 months
Secondary	Rate of change of serum CPK and CK-MM levels	measured in U/L using ELISA	up to 12 months

External Links

•   Diagnostic criteria for inflammatory myositis