Musculoskeletal Ultrasound with Elastography in the Evaluation of Muscle State in Rheumatoid Arthritis Patients

Evaluation of muscle state in rheumatoid arthritis patients. Application of elastography in the detection of muscle stiffness in rheumatoid arthritis

Study Overview

• Status: Not yet recruiting
• Conditions: Rheumatoid Arthritis; Musculoskeletal Ultrasound
• Intervention / Treatment: Device: Musculoskeletal Ultrasound with elastography

Detailed Description

Rheumatoid arthritis is a chronic debilitating disease. Muscle weakness is a common symptom in patients with rheumatoid arthritis (RA). From a metabolic perspective, muscle mass is determined by the balance between protein synthesis and degradation. People with RA note tenderness, stiffness, and pain in affected muscles.

In RA, chronic inflammation is a primary driver of muscle weakness. Persistent synovitis leads to the release of pro-inflammatory cytokines, such as tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6), which contribute to muscle atrophy and dysfunction. Joint damage and pain further limit physical activity, exacerbating muscle wasting through disuse atrophy. Additionally, the systemic inflammation associated with RA can lead to metabolic disturbances, including insulin resistance, which negatively impacts muscle protein synthesis and overall muscle health.

RA can cause a 25% to 70% reduction in muscular strength, typically caused by decreased skeletal muscle mass, ,Reduced muscle strength is usually considered to be a result of decreased muscle mass due to disuse atrophy. Rheumatoid cachexia, a term used in RA, is defined as a loss of skeletal muscle mass and with no, or little weight loss in fat mass Muscle weakness not only reduces the quality of life for the affected patients, but since patients' ability to work decreases it will also dramatically increase the burden on society (e.g. increased costs for long-term sick leave). Thus, RA severely affects both the individual and the society Given the complexity of muscle affection in RA , accurate assessment is essential for effective management. Conventional clinical methods, such as manual muscle testing and grip strength measurements, provide limited information on the underlying causes of muscle weakness. Advanced imaging techniques, such as conventional ultrasound (US) and shear wave elastography (SWE), offer a more comprehensive evaluation by providing detailed information on muscle morphology and stiffness.

• Study Type: Observational
• Enrollment (Estimated): 72

Contacts and Locations

• Study Contact: Name: Mostafa K Khedr, Resident; Phone Number: +201289452808; Email: Teeefakamel@gmail.com
• Study Contact Backup: Name: Ayat K Salah, Lecturer; Phone Number: +201026860251; Email: rheumatologi.ayat@med.aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients will be divided into two groups matched for age and sex :

Group A: rheumatoid arthritis will include 36 participants Group B: healthy participants (control) will include 36 participants

Description

Inclusion Criteria:

• Age 18:70 years
• RA patients with positive RF And Anti ccp

Exclusion Criteria:

• History of injury or operation of the lower limb and upper limbs .
• History or clinical signs of neuromuscular disorders.
• Patients on drugs causing myopathy or myositis
• History of chronic diseases : kidney and liver disease
• Diabetic patients .

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Rheumatoid arthritis patients	Device: Musculoskeletal Ultrasound with elastography; Musculoskeletal Ultrasound with elastography
Healthy control group	Device: Musculoskeletal Ultrasound with elastography; Musculoskeletal Ultrasound with elastography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of muscle state in rheumatoid arthritis patients by using musculoskeletal us	Baseline

Secondary Outcome Measures

Outcome Measure	Time Frame
Application of elastography in the detection of muscle stiffness in rheumatoid arthritis patients	Baseline

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Brennan FM, McInnes IB. Evidence that cytokines play a role in rheumatoid arthritis. J Clin Invest. 2008 Nov;118(11):3537-45. doi: 10.1172/JCI36389.
• Frontera WR, Ochala J. Skeletal muscle: a brief review of structure and function. Calcif Tissue Int. 2015 Mar;96(3):183-95. doi: 10.1007/s00223-014-9915-y. Epub 2014 Oct 8.
• Huffman KM, Jessee R, Andonian B, Davis BN, Narowski R, Huebner JL, Kraus VB, McCracken J, Gilmore BF, Tune KN, Campbell M, Koves TR, Muoio DM, Hubal MJ, Kraus WE. Molecular alterations in skeletal muscle in rheumatoid arthritis are related to disease activity, physical inactivity, and disability. Arthritis Res Ther. 2017 Jan 23;19(1):12. doi: 10.1186/s13075-016-1215-7.
• Londhe P, Guttridge DC. Inflammation induced loss of skeletal muscle. Bone. 2015 Nov;80:131-142. doi: 10.1016/j.bone.2015.03.015.

Helpful Links

• Numbness, Muscle Pain, and Other RA Symptoms

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: August 6, 2024
• First Submitted That Met QC Criteria: September 29, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 29, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Muscle state
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: Musculoskeletal US in RA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No