UltrasoundNCT04233255
Role of Ultrasound in Diagnosis of Muscle Diseases
An observational study of Ultrasound and Muscle Disease, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 2 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Ultrasound, Muscle Disease
- What is being tested?
- Neuromuscular Ultrasound (US), Electrophysiological studies and Seum CPK, CK-MM levels, Lactate dehydrogenase and alanine aminotransferase.
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 128 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2020to 1 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Neuromuscular Ultrasound in Diagnosis of Muscle Diseases
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.
Read the 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.
- Conditions
- Ultrasound, Muscle Disease
- Being tested
- Neuromuscular Ultrasound (US), Electrophysiological studies, Seum CPK, CK-MM levels, Lactate dehydrogenase and alanine aminotransferase.
- Keywords
- Ultrasound, Muscle, Electrophysiology
- Medical subject headings
- Muscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Ultrasound (US)Device
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 studiesDevice
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.
Seum CPK, CK-MM levels, Lactate dehydrogenase and alanine aminotransferase.Diagnostic test
measured in U/L using ELISA.
| Study group | Role | What they receive |
|---|---|---|
| Patients with muscle disease(myositis, hereditary myopathy) | 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. Receives: Device: Neuromuscular Ultrasound (US); Device: Electrophysiological studies; Diagnostic Test: Seum CPK, CK-MM levels, Lactate dehydrogenase and alanine aminotransferase. | |
| Healthy volunteers as control group | 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. Receives: Device: Neuromuscular Ultrasound (US); Device: Electrophysiological studies; Diagnostic Test: Seum CPK, CK-MM levels, Lactate dehydrogenase and alanine aminotransferase. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 12 months
Secondary outcomes (3)
Rate of change in Functional assessment of muscle weakness
Grading score from 0-10 according to affected muscles
Measured: up to 12 months
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)
Measured: up to 12 months
Rate of change of serum CPK and CK-MM levels
measured in U/L using ELISA
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Apr 2020
- Primary completion4 Apr 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for UltrasoundStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manar Nasr Abd-el-hakim Nasr, Assiut University
- Investigators
- Nageh F. El-Gammal, Doctorate, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04233255
- Sponsor's protocol ID
- RUDM
- Status last verified
- Feb 2025
- First submitted
- 15 Jan 2020
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20422195Boon 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.
PubMed 23524068Chiaramonte 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.
PubMed 30892439O'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.
PubMed 16371549Kubinova 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.
PubMed 30296982Mah 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.
PubMed 30430964Barohn 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.
PubMed 25037080Vanhoutte 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.
PubMed 22189568
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Neuromuscular Ultrasound in Diagnosis of Muscle Diseases
- ClinicalTrials.gov ID
- NCT04233255
- Acronym / sponsor ID
- RUDM
- Conditions
- Ultrasound, Muscle Disease
- Keywords
- Ultrasound, Muscle, Electrophysiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 4 Apr 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with muscle disease(myositis, hereditary myopathy) | – | Device: Neuromuscular Ultrasound (US), Device: Electrophysiological studies, Diagnostic Test: Seum CPK, CK-MM levels, Lactate dehydrogenase and alanine aminotransferase.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. |
| Healthy volunteers as control group | – | Device: Neuromuscular Ultrasound (US), Device: Electrophysiological studies, Diagnostic Test: Seum CPK, CK-MM levels, Lactate dehydrogenase and alanine aminotransferase.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. |
Who may qualify
- Ages
- 2 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Healthy volunteers as control group, Patients with muscle disease(myositis, hereditary myopathy) |
| Electrophysiological studiesIncludes: 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. | Device | Healthy volunteers as control group, Patients with muscle disease(myositis, hereditary myopathy) |
| Seum CPK, CK-MM levels, Lactate dehydrogenase and alanine aminotransferase.measured in U/L using ELISA. | Diagnostic test | Healthy volunteers as control group, Patients with muscle disease(myositis, hereditary myopathy) |
Primary outcome
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.
3 secondary outcomes
Rate of change in Functional assessment of muscle weakness
Time frame: up to 12 months
Rate of change in manual muscle strength testing by EXPANDED MRC (The modified Medical Research Council)
Time frame: up to 12 months
Rate of change of serum CPK and CK-MM levels
Time frame: up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Results publication: PubMed 20422195Wattjes 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.
- Results publication: PubMed 23524068Boon 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.
- Results publication: PubMed 30892439Chiaramonte 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.
- Results publication: PubMed 16371549O'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.
- Results publication: PubMed 30296982Kubinova 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.
- Results publication: PubMed 30430964Mah 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.
- Results publication: PubMed 25037080Barohn 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.
- Results publication: PubMed 22189568Vanhoutte 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.
- Diagnostic criteria for inflammatory myositisLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Ultrasound
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)
Recruiting
Minimum Effective Local Anesthetic Volume for Ultrasound Guided Superior Trunk Block
Musculoskeletal Diseases or Conditions
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nageh F. El-Gammal, Doctorate study chair
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound and Muscle Disease, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04233255, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.