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Elastography in Patients With Idiopathic Inflammatory Myopathies

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03897803
Enrollment
80
Registered
2019-04-01
Start date
2019-04-15
Completion date
2020-11-01
Last updated
2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Inflammatory Myopathies

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

Interventions

DIAGNOSTIC_TESTstrain 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.

Sponsors

Benha University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Manual muscle testing6 monthsKendall'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) levels6 monthsCK measured in U/L using ELISA
Serum Lactate dehydrogenase (LDH) levels6 monthsLDHmeasured in IU/L using ELISA
alanine aminotransferase (ALT)6 monthsALT measured in U/L using ELISA
Aspartate aminotransferase (AST)6 monthsAST measured in U/L using ELISA
motor unit potential (MUP) duration6 monthsquantitative 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 amplitude6 monthsquantitative 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 monthsquantitative 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 .
muscle echo intenisity (EI)6 MONTHSEI 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 scale6 monthsused 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 monthsThe 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 monthsThere 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)6months20 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)6monthsThe 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 assessment6 monthsvisual analogue scale rating, a score of 0-10 (down to 1 decimal place) is used, higher score means worse outcome
PATIENT/PARENT GLOBAL ACTIVITY assessment6 monthsvisual analogue scale rating, a score of 0-10 (down to 1 decimal place) is used, higher score means worse outcome

Countries

Egypt

Contacts

Primary ContactWaleed Hassan, MD
waleed22101979@yahoo.com01095000886
Backup ContactMarwa Mahgoup, MD
marwayahiamlm@gmail.com01005530882

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026