Elastography in Patients With Idiopathic Inflammatory Myopathies
- Conditions
- Idiopathic Inflammatory Myopathies
- Interventions
- Diagnostic Test: strain elastography
- Registration Number
- NCT03897803
- Lead Sponsor
- Benha University
- Brief Summary
The aim of our study was to assess the performance of compression-strain US elastography in patients with idiopathic inflammatory myopathies over time and to study these findings with clinical and functional parameters as well as biochemical and electromyographic tests.
- Detailed Description
This study will be carried out on four groups:
Group (I): twenty children diagnosed to have idiopathic inflammatory myopathies(IIM)
* Group (II): twenty adults diagnosed to have IIM
* Group (III):20 healthy children matching age and sex as first control group to children with IIM .
* Group (VI):20 healthy adults matching age and sex as second control group to adults with IIM.
All patients will be evaluated at baseline at \& 4-months follow up using Semi-Quantitative strain elastography
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- to fulfill criteria of diagnosis of childhood and adult idiopathic inflammatory myopathies
- Patients with age less than 2 years were excluded from the study due to inability to perform manual muscle testing and functional scales.
- The presence of a associated illness that may result in nerve or muscle affection
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group (I):juvenile dermatomyositis (JDM) strain elastography Group (I): twenty children diagnosed to have juvenile dermatomyositis (JDM) Who will be evaluated using using strain elastography to assess muscle stiffness at baseline and after 4 months. . Group (II):idiopathic inflammatory myopathies(IIM) strain elastography Group (II): twenty adults diagnosed to have idiopathic inflammatory myopathies(IIM) Who will be evaluated using using strain elastography to assess muscle stiffness at baseline and after 4 months. * • Group (III): juvenile control group strain elastography 20 healthy children matching age and sex as first control group to children with JDM .Who will be evaluated at baseline using using strain elastography to assess muscle stiffness . . Group (VI):adult control group strain elastography 20 healthy adults matching age and sex as second control group to adults with IIM. Who will be evaluated at baseline using using strain elastography to assess muscle stiffness .
- Primary Outcome Measures
Name Time Method Serum Lactate dehydrogenase (LDH) levels 6 months LDHmeasured in IU/L using ELISA
alanine aminotransferase (ALT) 6 months ALT measured in U/L using ELISA
Aspartate aminotransferase (AST) 6 months AST measured in U/L using ELISA
motor unit potential (MUP) duration 6 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 6 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) 6 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 .
Manual muscle testing 6 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)
Serum creatine kinase (CK) levels 6 months CK measured in U/L using ELISA
muscle echo intenisity (EI) 6 MONTHS EI is assessed during muscle ultrasound evaluation means of computer-assisted grayscale histogram analysis of Adobe Photoshop . echo intensity was calculated based on a histogram analysis which expresses every pixel as a value between 0 (black) and 255 (white)..he 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 6 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)
MYOSITIS DISEASE ACTIVITY ASSESSMENT TOOL (MDAAT) 6 months The MDAAT is a combined tool that includes the Myositis Disease Activity Assessment visual analog scale (VAS) (MYOACT) and the Myositis Intention to Treat Activities Index (MITAX).it Assesses 6 extramuscular organs to produce a global extramuscular score, and the muscle score, which gives a total disease activity index score. Scores range from 0-60 for the extramuscular MYOACT score and 0-70 for the total MYOACT score, and they range from 0-54 for the Extramuscular MITAX score and 0-63 for the total MITAX score. higher scores indicates worse outcome
CHILDHOOD HEALTH ASSESSMENT QUESTIONNAIRE (CHAQ) 6 months There are 30 items in the Disability Index; one item each in the Discomfort Index and Health Status Index. Score range. The range is 0-3. Higher scores reflect greater disability.
HEALTH ASSESSMENT QUESTIONNAIRE (HAQ) 6months 20 questions grouped into eight subscales (dressing and grooming, arising, eating, walking, hygiene, reach, grip, activities). (score = 0 to 3 with higher score means worse outcome ). The highest score for any question determines the score for the subscale in question. The HAQ disability index is calculated as the sum of the scores for various subscales,divided by the number of subscales responded to, and results in a score between 0 and 3. higher score means worse outcome
MYOSITIS DAMAGE INDEX (MDI) 6months The MDI measures specific manifestations in 11 organ systems The MDI also includes a series of visual analog scales (VAS) to quantify damage severity in a given organ system. The VAS are summed together for a potential score of 0-110 with higher scores has worse prognosis
PHYSICIAN GLOBAL ACTIVITY assessment 6 months visual analogue scale rating, a score of 0-10 (down to 1 decimal place) is used, higher score means worse outcome
PATIENT/PARENT GLOBAL ACTIVITY assessment 6 months visual analogue scale rating, a score of 0-10 (down to 1 decimal place) is used, higher score means worse outcome
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Benha University Hospital
🇪🇬Banhā, Qalubiya, Egypt