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Clinical Trials/NCT04233255
NCT04233255
Completed
Not Applicable

The Role of Neuromuscular Ultrasound in Diagnosis of Muscle Diseases

Assiut University1 site in 1 country128 target enrollmentApril 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ultrasound
Sponsor
Assiut University
Enrollment
128
Locations
1
Primary Endpoint
The rate of decline of patients with muscle disorder versus normal subjects as assessed by quantitative ultrasound measurements and electrophysiology studies.
Status
Completed
Last Updated
last year

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
April 1, 2020
End Date
July 1, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Manar Nasr Abd-el-hakim Nasr

principal investigator

Assiut University

Eligibility Criteria

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
  • 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

Outcomes

Primary Outcomes

The rate of decline of patients with muscle disorder versus normal subjects as assessed by quantitative ultrasound measurements and electrophysiology studies.

Time Frame: up to 12 months

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.

Secondary Outcomes

  • Rate of change in Functional assessment of muscle weakness(up to 12 months)
  • Rate of change of serum CPK and CK-MM levels(up to 12 months)
  • Rate of change in manual muscle strength testing by EXPANDED MRC (The modified Medical Research Council)(up to 12 months)

Study Sites (1)

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