Magnetic Resonance Elastography of Skeletal muscle in scleroderma with muscle involvement compared to Muscle biopsy: a pilot study

Not Applicable

• Conditions: - Systemic sclerosis- Myositis- Myopathy; Myositis; Muscle stiffness; MRE

• Registration Number: TCTR20201105004
• Lead Sponsor: Faculty of medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-05
• Study Completion: 2021-01-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.Systemic sclerosis, age >/= 18 years old
2.Abnormal increased CPK enzyme level above upper normal limited (> 200 IU/L).
3.Muscle weakness ≤grade IV based on manual muscle testing.

Exclusion Criteria

1.Deny performing muscle biopsy.
2.Ongoing immunosuppressive drug and unable to stop the drug due to prevent disease control flare up during the time of MRE examination (low dose steroid equivalent with prednisolone ≤15 mg/d is allow during MRE examination)
3.Having contraindication to perform muscle biopsy
4.Underlying bleeding disorder or coagulopathy
5.Take any anticoagulant, antiplatelet, or other medicines that affect blood clotting
6.Infection of the biopsy site
7.Absolute contraindication to perform MRI and MRE.
8.Pregnancy or lactation
9.Advanced stage of cancer
10.Sepsis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
muscle stiffness at study date shear modulus, wave length, decay constant

Secondary Outcome Measures

Name	Time	Method
differences between myositis and myopathy at study date shear modulus, wave length, decay constan