Inflammatory MyopathyNCT03786913
Quantitative Muscle Ultrasound as a Marker of Progression in Children With Muscular Diseases
An observational study of Inflammatory Myopathy and Duchenne Muscular Dystrophy, run by Benha University at 1 site in Egypt.
Trial summary
The aim of our study is to Assess skeletal muscle structural status in children with inflammatory myositis and Duchenne muscular dystrophy using musculoskeletal ultrasound and to perform a longitudinal follow up of these changes over 2 years and to assess the relation between these findings with clinical parameters… Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Inflammatory Myopathy, Duchenne Muscular Dystrophy
- What is being tested?
- Quantitative muscle ultrasound measurements
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Mar 2016to 2 Feb 2019
- 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 16 years
- All sexes
- Child
Study population: the study will be performed on 2 groups Group (I): fifty children diagnosed to have inflammatory myositis and Duchenne muscular dystrophy Group (II): including 20 healthy children matching age and sex as control group.
Who may be able to join
- children with Duchenne muscular dystrophy (DMD). Diagnosis with DMD was established according to DMD diagnostic criteria (Jennekens et al., 1991).
- children with juvenile dermatomyositis (JDM) according to Bohan and Peter diagnostic criteria ( (Bohan and Peter, 1975).
Who cannot join
- Patients with age less than 2 years were excluded from the study due to inability to perform manual muscle testing and functional scales.
- If no final diagnosis could be established.
- The presence of a concomitant illness that may result in peripheral neuropathy or myopathy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantitative Muscle Ultrasound as a Monitoring Tool of Disease Progression in Children With Inflammatory Myositis and Duchenne Muscular Dystrophy
The aim of our study is to Assess skeletal muscle structural status in children with inflammatory myositis and Duchenne muscular dystrophy using musculoskeletal ultrasound and to perform a longitudinal follow up of these changes over 2 years and to assess the relation between these findings with clinical parameters, functional scales, biochemical and electromyographic tests.
Read the detailed description
This study will be carried out on two groups:
- Group (I): fifty children diagnosed to have duchenne muscular dystrophy and inflammatory myositis.
Group (II): including 20 healthy children matching age and sex as control group.
patients will be subjected to
(A) Clinical evaluation
- Complete history taking.
- Thorough clinical examination.
- Body mass index (BMI) assessment.
- Quantitative muscle strength tests
- Functional grading
- Childhood Myositis Assessment Scale. 7 (B) Laboratory assessment:
All patients will be subjected to the following measurements:
- Serum creatine kinase levels (CK).
- Serum Lactate dehydrogenase levels
- Serum of Liver enzymes (SGOT\& SGPT) levels. (C) Electromyographic (EMG) assessment: (D) Musculoskeletal ultrasound assessment (E) Statistical analysis
- Conditions
- Inflammatory Myopathy, Duchenne Muscular Dystrophy
- Being tested
- Quantitative muscle ultrasound measurements
- Keywords
- Inflammatory myositis, Duchenne Muscular Dystrophy, Musculoskeletal ultrasound
- Medical subject headings
- Myositis, Muscular Dystrophy, Duchenne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative muscle ultrasound measurementsDiagnostic test
Quantitative ultrasound measurements will be performed to biceps, forearm flexors, quadriceps and tibialis anterior 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.
| Study group | Role | What they receive |
|---|---|---|
| children with muscle disease | fifty children diagnosed to have inflammatory myositis or Duchenne muscular dystrophy in whom Quantitative muscle ultrasound measurements will be performed .The captured images will be analyzed for echo intensity by means of computer-assisted grayscale histogram analysis at baseline and after 24 months. Receives: Diagnostic Test: Quantitative muscle ultrasound measurements | |
| control group | 20 healthy children matching age and sex as control group in whom Quantitative muscle ultrasound measurement will be performed at baseline Receives: Diagnostic Test: Quantitative muscle ultrasound measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kendall's manual muscle testing
Kendall's 0 -10 point scale measures strength of each muscle group score 0 is the weakest (worst) and 10 is the strongest (best). The following muscles were tested bilaterally: the biceps brachii muscle (BB), the forearm flexors (FF), the rectus femoris muscle (RF), the tibialis anterior muscle (TA)
Measured: 24 months
Childhood myositis assessment scale
used to assess the severity of muscle involvement in children with dermatomyositis. The scores for the 14 items are summated to give a total score ranging from 0 (worst) to 52 (best)
Measured: 24 months
Serum creatine kinase (CK) levels
CK measured in U/L using ELISA
Measured: 24 months
Serum Lactate dehydrogenase (LDH) levels
CK measured in IU/L using ELISA
Measured: 24 months
Aspartate aminotransferase (AST)
AST measured in U/L using ELISA
Measured: 24 MONTHS
alanine aminotransferase (ALT)
ALT measured in U/L using ELISA
Measured: 24 months
motor unit potential (MUP) duration
quantitative electromyography (QEMG) in the most affected rectus femoris and biceps brachii muscles will be performed and The motor unit potentials will be reviewed offline for the needle-detected EMG signals will be analyzed by the device software for the MUP duration measured in milliseconds.
Measured: 24 months
motor unit peak-to-peak amplitude
quantitative electromyography (QEMG) in the most affected rectus femoris and biceps brachii muscles will be performed and The motor unit potentials will be reviewed offline for the needle-detected EMG signals will be analyzed by the device software for the peak-to-peak amplitude measured in microvolt
Measured: 24 months
motor unit area to amplitude ratio (AAR)
quantitative electromyography (QEMG) in the most affected rectus femoris and biceps brachii muscles will be performed and The motor unit potentials will be reviewed offline for the needle-detected EMG signals will be analyzed by the device software for the motor unit AAR .
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start8 Mar 2016
- Primary completion2 Feb 2019
- Study completion2 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory MyopathyStudies of the same condition, open and under way.
- More trials run by Benha 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed Ahmed Salaheldeen Hassan, Benha University
- Investigators
- Waleed Hassan, MD, Principal investigator, Benha university- Qaluibya- Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786913
- Sponsor's protocol ID
- BenhaU122018
- Status last verified
- Feb 2019
- First submitted
- 21 Dec 2018
- Last updated
- 8 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Muscle Ultrasound as a Monitoring Tool of Disease Progression in Children With Inflammatory Myositis and Duchenne Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT03786913
- Acronym / sponsor ID
- BenhaU122018
- Conditions
- Inflammatory Myopathy, Duchenne Muscular Dystrophy
- Keywords
- Inflammatory myositis, Duchenne Muscular Dystrophy, Musculoskeletal ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 8 Mar 2016 (actual)
- Primary completion
- 2 Feb 2019 (actual)
- Study completion
- 2 Feb 2019 (actual)
- First posted
- 26 Dec 2018 (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 aim of our study is to Assess skeletal muscle structural status in children with inflammatory myositis and Duchenne muscular dystrophy using musculoskeletal ultrasound and to perform a longitudinal follow up of these changes over 2 years and to assess the relation between these findings with clinical parameters, functional scales, biochemical and electromyographic tests.
Detailed description
This study will be carried out on two groups:
- Group (I): fifty children diagnosed to have duchenne muscular dystrophy and inflammatory myositis.
Group (II): including 20 healthy children matching age and sex as control group.
patients will be subjected to
(A) Clinical evaluation
- Complete history taking.
- Thorough clinical examination.
- Body mass index (BMI) assessment.
- Quantitative muscle strength tests
- Functional grading
- Childhood Myositis Assessment Scale. 7 (B) Laboratory assessment:
All patients will be subjected to the following measurements:
- Serum creatine kinase levels (CK).
- Serum Lactate dehydrogenase levels
- Serum of Liver enzymes (SGOT\& SGPT) levels. (C) Electromyographic (EMG) assessment: (D) Musculoskeletal ultrasound assessment (E) Statistical analysis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children with muscle disease | – | Diagnostic Test: Quantitative muscle ultrasound measurementsfifty children diagnosed to have inflammatory myositis or Duchenne muscular dystrophy in whom Quantitative muscle ultrasound measurements will be performed .The captured images will be analyzed for echo intensity by means of computer-assisted grayscale histogram analysis at baseline and after 24 months. |
| control group | – | Diagnostic Test: Quantitative muscle ultrasound measurements20 healthy children matching age and sex as control group in whom Quantitative muscle ultrasound measurement will be performed at baseline |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- the study will be performed on 2 groups Group (I): fifty children diagnosed to have inflammatory myositis and Duchenne muscular dystrophy Group (II): including 20 healthy children matching age and sex as control group.
Key inclusion criteria (2 listed)
- children with Duchenne muscular dystrophy (DMD). Diagnosis with DMD was established according to DMD diagnostic criteria (Jennekens et al., 1991).
- children with juvenile dermatomyositis (JDM) according to Bohan and Peter diagnostic criteria ( (Bohan and Peter, 1975).
Key exclusion criteria (3 listed)
- Patients with age less than 2 years were excluded from the study due to inability to perform manual muscle testing and functional scales.
- If no final diagnosis could be established.
- The presence of a concomitant illness that may result in peripheral neuropathy or 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 |
|---|---|---|
| Quantitative muscle ultrasound measurementsQuantitative ultrasound measurements will be performed to biceps, forearm flexors, quadriceps and tibialis anterior 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. | Diagnostic test | children with muscle disease, control group |
Primary outcome
Kendall's manual muscle testing
Time frame: 24 months
Kendall's 0 -10 point scale measures strength of each muscle group score 0 is the weakest (worst) and 10 is the strongest (best). The following muscles were tested bilaterally: the biceps brachii muscle (BB), the forearm flexors (FF), the rectus femoris muscle (RF), the tibialis anterior muscle (TA)
Childhood myositis assessment scale
Time frame: 24 months
used to assess the severity of muscle involvement in children with dermatomyositis. The scores for the 14 items are summated to give a total score ranging from 0 (worst) to 52 (best)
Serum creatine kinase (CK) levels
Time frame: 24 months
CK measured in U/L using ELISA
Serum Lactate dehydrogenase (LDH) levels
Time frame: 24 months
CK measured in IU/L using ELISA
Aspartate aminotransferase (AST)
Time frame: 24 MONTHS
AST measured in U/L using ELISA
alanine aminotransferase (ALT)
Time frame: 24 months
ALT measured in U/L using ELISA
motor unit potential (MUP) duration
Time frame: 24 months
quantitative electromyography (QEMG) in the most affected rectus femoris and biceps brachii muscles will be performed and The motor unit potentials will be reviewed offline for the needle-detected EMG signals will be analyzed by the device software for the MUP duration measured in milliseconds.
motor unit peak-to-peak amplitude
Time frame: 24 months
quantitative electromyography (QEMG) in the most affected rectus femoris and biceps brachii muscles will be performed and The motor unit potentials will be reviewed offline for the needle-detected EMG signals will be analyzed by the device software for the peak-to-peak amplitude measured in microvolt
motor unit area to amplitude ratio (AAR)
Time frame: 24 months
quantitative electromyography (QEMG) in the most affected rectus femoris and biceps brachii muscles will be performed and The motor unit potentials will be reviewed offline for the needle-detected EMG signals will be analyzed by the device software for the motor unit AAR .
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 8 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Inflammatory Myopathy
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
RecruitingPhase 1
A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease
Systemic Lupus Erythematosus (With and Without Nephritis), Idiopathic Inflammatory Myopathy
RecruitingPhase 1/2
A Study of AZD0120 in Autoimmune Diseases
Systemic Sclerosis, Idiopathic Inflammatory Myopathies
RecruitingPhase 1/2
A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)
Systemic Sclerosis, Idiopathic Inflammatory Myopathies
Not yet recruitingPhase 3
A Study to Understand How Nerandomilast Works in People With Active Idiopathic Inflammatory Myopathies
Idiopathic Inflammatory Myopathies
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.
Waleed Hassan, MD principal investigator
Benha university- Qaluibya- Egypt
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 Inflammatory Myopathy and Duchenne Muscular Dystrophy, run by Benha 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 2 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 8 Feb 2019. 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?
Kendall's manual muscle testing (time frame: 24 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2019; AzTrials last refreshed its copy on 8 Nov 2026.