Clinical trial NCT04233255: Role of Ultrasound in Diagnosis of Muscle Diseases
Official title: The Role of Neuromuscular Ultrasound in Diagnosis of Muscle Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasound
Muscle Disease
Keywords: Ultrasound
Muscle
Electrophysiology
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 128
Sex: ALL
Minimum age (years): 2
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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 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

Primary outcomes:
measure: The rate of decline of patients with muscle disorder versus normal subjects as assessed by quantitative ultrasound measurements and electrophysiology studies.
timeFrame: up to 12 months
Secondary outcomes:
measure: Rate of change in Functional assessment of muscle weakness
timeFrame: up to 12 months
measure: Rate of change in manual muscle strength testing by EXPANDED MRC (The modified Medical Research Council)
timeFrame: up to 12 months
measure: Rate of change of serum CPK and CK-MM levels
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
affiliation: Assiut University
name: Nageh F. El-Gammal, Doctorate
role: STUDY_CHAIR
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