Elastography in Patients With Idiopathic Inflammatory Myopathies

NCT ID: NCT03897803

Last Updated: 2020-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-15

Study Completion Date

2020-11-01

Brief Summary

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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

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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

Conditions

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Idiopathic Inflammatory Myopathies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

.

strain elastography

Intervention Type DIAGNOSTIC_TEST

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.

* •

strain elastography

Intervention Type DIAGNOSTIC_TEST

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 .

.

strain elastography

Intervention Type DIAGNOSTIC_TEST

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 .

strain elastography

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Waleed Ahmed Salaheldeen Hassan

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Waleed A Hassan, MD

Role: PRINCIPAL_INVESTIGATOR

Benha university- Qaluibya- Egypt

Locations

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Benha University Hospital

Banhā, Qalyubia Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Waleed Hassan, MD

Role: CONTACT

01095000886 ext. +2

Marwa Mahgoup, MD

Role: CONTACT

01005530882 ext. +2

Facility Contacts

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Marwa Y Mahgoup, MD

Role: primary

01005530882 ext. +2

Waleed Hassan, MD

Role: backup

00201095000886 ext. +2

Other Identifiers

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BenhaU2022019

Identifier Type: -

Identifier Source: org_study_id

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