Role of Ultrasound in Diagnosis of Muscle Diseases

A

Assiut University

Status

Enrolling

Conditions

Muscle Disease
Ultrasound

Treatments

Device: Electrophysiological studies
Device: Neuromuscular Ultrasound (US)
Diagnostic Test: Seum CPK, CK-MM levels, Lactate dehydrogenase and alanine aminotransferase.

Study type

Observational

Funder types

Other

Identifiers

NCT04233255
RUDM

Details and patient eligibility

About

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.

Full 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.

Enrollment

62 estimated patients

Sex

All

Ages

2 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

62 participants in 2 patient groups

Patients with muscle disease(myositis, hereditary myopathy)
Description:
Includes 32 symptomatic patients with muscle disease subdivided into two subgroups (a) 16 patients with acute inflammatory myositis; And (b)16 patients 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.
Treatment:
Diagnostic Test: Seum CPK, CK-MM levels, Lactate dehydrogenase and alanine aminotransferase.
Device: Neuromuscular Ultrasound (US)
Device: Electrophysiological studies
Healthy volunteers as control group
Description:
Includes 32 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.
Treatment:
Diagnostic Test: Seum CPK, CK-MM levels, Lactate dehydrogenase and alanine aminotransferase.
Device: Neuromuscular Ultrasound (US)
Device: Electrophysiological studies

Trial contacts and locations

1

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Central trial contact

Anwar M. Ali, Doctorate; Manar N. Abd-el-Hakim, Master

Data sourced from clinicaltrials.gov

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