Elastography in Patients With Idiopathic Inflammatory Myopathies

Elastography as a Follow up Imaging Tool in Patients With Idiopathic Inflammatory Myopathies

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.

Study Overview

• Status: Unknown
• Conditions: Idiopathic Inflammatory Myopathies
• Intervention / Treatment: Diagnostic test: strain elastography

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

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• Egypt
  • Qalubiya
    • Banhā, Qalubiya, Egypt, 13518
      • Recruiting
      • Benha University Hospital
      • Contact: Marwa Y Mahgoup, MD; Phone Number: +2 01005530882; Email: marwayahiamlm@gmail.com
      • Contact: Waleed Hassan, MD; Phone Number: +2 00201095000886; Email: waleed22101979@yahoo.com
      • Principal Investigator: Waleed A Hassan, MD
      • Sub-Investigator: Marwa Y Mahgoup, MD
      • Sub-Investigator: Shorouk Z Abdelshafy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

This study will be carried out on four groups:

Group (I): thirty children diagnosed to have idiopathic inflammatory myopathies(IIM)

• Group (II): thirty adults diagnosed to have IIM
• Group (III):30 healthy children matching age and sex as first control group to children with IIM .
• Group (VI):30 healthy adults matching age and sex as second control group to adults with IIM.

Description

Inclusion Criteria:

• to fulfill criteria of diagnosis of childhood and adult idiopathic inflammatory myopathies

Exclusion Criteria:

• 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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group (I):juvenile dermatomyositis (JDM); 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. .	Diagnostic test: strain elastography; strain elastography as apart of muscle ultrasound examination of the biceps brachii and rectus femoris muscles will be performed to the patients and control groups at baseline evaluation and after 4 months follow up in the patients groups only.
Group (II):idiopathic inflammatory myopathies(IIM); 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.; •	Diagnostic test: strain elastography; strain elastography as apart of muscle ultrasound examination of the biceps brachii and rectus femoris muscles will be performed to the patients and control groups at baseline evaluation and after 4 months follow up in the patients groups only.
Group (III): juvenile control group; 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 . .	Diagnostic test: strain elastography; strain elastography as apart of muscle ultrasound examination of the biceps brachii and rectus femoris muscles will be performed to the patients and control groups at baseline evaluation and after 4 months follow up in the patients groups only.
Group (VI):adult control group; 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 .	Diagnostic test: strain elastography; strain elastography as apart of muscle ultrasound examination of the biceps brachii and rectus femoris muscles will be performed to the patients and control groups at baseline evaluation and after 4 months follow up in the patients groups only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	6 months
Serum creatine kinase (CK) levels	CK measured in U/L using ELISA	6 months
Serum Lactate dehydrogenase (LDH) levels	LDHmeasured in IU/L using ELISA	6 months
alanine aminotransferase (ALT)	ALT measured in U/L using ELISA	6 months
Aspartate aminotransferase (AST)	AST measured in U/L using ELISA	6 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.	6 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	6 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 .	6 months
muscle echo intenisity (EI)	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)	6 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)	6 months
MYOSITIS DISEASE ACTIVITY ASSESSMENT TOOL (MDAAT)	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	6 months
CHILDHOOD HEALTH ASSESSMENT QUESTIONNAIRE (CHAQ)	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.	6 months
HEALTH ASSESSMENT QUESTIONNAIRE (HAQ)	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	6months
MYOSITIS DAMAGE INDEX (MDI)	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	6months
PHYSICIAN GLOBAL ACTIVITY assessment	visual analogue scale rating, a score of 0-10 (down to 1 decimal place) is used, higher score means worse outcome	6 months
PATIENT/PARENT GLOBAL ACTIVITY assessment	visual analogue scale rating, a score of 0-10 (down to 1 decimal place) is used, higher score means worse outcome	6 months

Collaborators and Investigators

• Sponsor: Benha University
• Investigators: Principal Investigator: Waleed A Hassan, MD, Benha university- Qaluibya- Egypt

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 15, 2019
• Primary Completion (ANTICIPATED): November 1, 2020
• Study Completion (ANTICIPATED): November 1, 2020

Study Registration Dates

• First Submitted: March 29, 2019
• First Submitted That Met QC Criteria: March 29, 2019
• First Posted (ACTUAL): April 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 16, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Muscular Diseases; Myositis
• Other Study ID Numbers: BenhaU2022019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No