Elastography as a Follow up Imaging Tool in Patients With Idiopathic Inflammatory Myopathies
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Serum Lactate dehydrogenase (LDH) levels
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •to fulfill criteria of diagnosis of childhood and adult idiopathic inflammatory myopathies
排除标准
- •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
结局指标
主要结局
Serum Lactate dehydrogenase (LDH) levels
时间窗: 6 months
LDHmeasured in IU/L using ELISA
alanine aminotransferase (ALT)
时间窗: 6 months
ALT measured in U/L using ELISA
Aspartate aminotransferase (AST)
时间窗: 6 months
AST measured in U/L using ELISA
motor unit potential (MUP) duration
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 6 months
CK measured in U/L using ELISA
muscle echo intenisity (EI)
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 6 months
visual analogue scale rating, a score of 0-10 (down to 1 decimal place) is used, higher score means worse outcome
次要结局
未报告次要终点
研究者
Waleed Ahmed Salaheldeen Hassan
Assistant professor
Benha University