Inflammatory Muscle DiseaseNCT05738590
Inflammatory and Degenerative Muscle Disease
An observational study of Inflammatory Muscle Disease, run by Assiut University.
Trial summary
Correlation between clinical , ultrasonographical, neurophysiological and histopathological findings in muscle diseases of different etiologies. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammatory Muscle Disease
- What is being tested?
- muscle biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 28 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patients with muscle disease of different etiologies aged from 18 years to 75 years, of both sex
Who may be able to join
- Muscle diseases of different etiologies.
- Any age.
Who cannot join
- Patient refuse to participate.
- The anatomy is altered due to severe trauma, tumor , or surgery.
- Severe deformity preventing examination.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Neurophysiological, Sonographical and Pathological Findings in Patients With Inflammatory Versus Degenerative Muscle Diseases
Correlation between clinical , ultrasonographical, neurophysiological and histopathological findings in muscle diseases of different etiologies.
- Conditions
- Inflammatory Muscle Disease
- Being tested
- muscle biopsy
- Medical subject headings
- Myositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
muscle biopsyProcedure or surgery
Also called neurophysiology(nerve conduction,electromyography), muscle ultrasound
true cut needle biopsy
| Study group | Role | What they receive |
|---|---|---|
| inflammatory muscle disease | Not described Receives: Procedure: muscle biopsy | |
| degenerative muscle disease | Not described Receives: Procedure: muscle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
microscopic picture of muscle in inflammatory and degenerative muscle disease
true cut needle muscle biopsy is done to differentiate between inflammatory and degenerative muscle disease in microsopic picture
Measured: 1 year
Secondary outcomes (2)
muscle ultrasound in inflammatory and degenerative muscle disease
muscle ultrasound picture and dimensions in inflammatory and degenerative muscle disease
Measured: 1 year
neurophysiology in inflammatory and degenerative muscle disease
electromyography changes in inflammatory and degenerative muscle disease
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start1 Apr 2023 (estimated)
- Primary completion31 Mar 2024 (estimated)
- Study completion28 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Muscle DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huda Mahmoud Sayed Abdelal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738590
- Sponsor's protocol ID
- muscle disease neurophysiology
- Status last verified
- Feb 2023
- First submitted
- 24 Jan 2023
- Last updated
- 22 Feb 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological, Sonographical and Pathological Findings in Patients With Inflammatory Versus Degenerative Muscle Diseases
- ClinicalTrials.gov ID
- NCT05738590
- Acronym / sponsor ID
- muscle disease neurophysiology
- Conditions
- Inflammatory Muscle Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 28 May 2024 (estimated)
- First posted
- 22 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Correlation between clinical , ultrasonographical, neurophysiological and histopathological findings in muscle diseases of different etiologies.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inflammatory muscle disease | – | Procedure: muscle biopsy |
| degenerative muscle disease | – | Procedure: muscle biopsy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patients with muscle disease of different etiologies aged from 18 years to 75 years, of both sex
Key inclusion criteria (2 listed)
- Muscle diseases of different etiologies.
- Any age.
Key exclusion criteria (3 listed)
- Patient refuse to participate.
- The anatomy is altered due to severe trauma, tumor , or surgery.
- Severe deformity preventing examination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| muscle biopsyAlso: neurophysiology(nerve conduction,electromyography), muscle ultrasoundtrue cut needle biopsy | Procedure or surgery | degenerative muscle disease, inflammatory muscle disease |
Primary outcome
microscopic picture of muscle in inflammatory and degenerative muscle disease
Time frame: 1 year
true cut needle muscle biopsy is done to differentiate between inflammatory and degenerative muscle disease in microsopic picture
2 secondary outcomes
muscle ultrasound in inflammatory and degenerative muscle disease
Time frame: 1 year
neurophysiology in inflammatory and degenerative muscle disease
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Muscle Disease, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact huda mahmoud, Dr (01119502695, hudamahmoud000@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microscopic picture of muscle in inflammatory and degenerative muscle disease (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.