Elastography in Patients With Idiopathic Inflammatory Myopathies

Idiopathic Inflammatory Myopathies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03897803
• Other study ID #: BenhaU2022019
• Status: Recruiting
• Start date: April 15, 2019
• Est. completion date: November 1, 2020

Study information

• Verified date: October 2020
• Source: Benha University
• Contact: Waleed Hassan, MD
• Phone: 01095000886
• Email: waleed22101979[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 1, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Idiopathic Inflammatory Myopathies
• Muscular Diseases
• Myositis

Intervention

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.

Locations

Country	Name	City	State
Egypt	Benha University Hospital	Banha	Qalubiya

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Serum creatine kinase (CK) levels	CK measured in U/L using ELISA	6 months
Primary	Serum Lactate dehydrogenase (LDH) levels	LDHmeasured in IU/L using ELISA	6 months
Primary	alanine aminotransferase (ALT)	ALT measured in U/L using ELISA	6 months
Primary	Aspartate aminotransferase (AST)	AST measured in U/L using ELISA	6 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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