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Not yet recruiting NCT06620484

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

Observational Rheumatoid Arthritis Musculoskeletal Ultrasound

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Musculoskeletal Ultrasound with elastography.
Who it may be relevant to
Registry conditions: Rheumatoid Arthritis, Musculoskeletal Ultrasound. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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.

Interventions

  • Device Musculoskeletal Ultrasound with elastography
    Musculoskeletal Ultrasound with elastography

Primary outcome measures

  • Evaluation of muscle state in rheumatoid arthritis patients by using musculoskeletal us [Time frame: Baseline]
Secondary outcome measures (1)
  • Application of elastography in the detection of muscle stiffness in rheumatoid arthritis patients [Time frame: Baseline]

Eligibility criteria

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 .

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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. PMID 25294644
  • 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. PMID 18982160
  • 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. PMID 28114971
  • Londhe P, Guttridge DC. Inflammation induced loss of skeletal muscle. Bone. 2015 Nov;80:131-142. doi: 10.1016/j.bone.2015.03.015. PMID 26453502

Identifiers

NCT: NCT06620484 · Musculoskeletal US in RA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗