Rheumatoid ArthritisNCT06620484
Musculoskeletal Ultrasound with Elastography in the Evaluation of Muscle State in Rheumatoid Arthritis Patients
An observational study of Rheumatoid Arthritis and Musculoskeletal Ultrasound, run by Assiut University.
Trial summary
Evaluation of muscle state in rheumatoid arthritis patients. Application of elastography in the detection of muscle stiffness in rheumatoid arthritis Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Musculoskeletal Ultrasound
- What is being tested?
- Musculoskeletal Ultrasound with elastography
- Type of treatment
- Medical device
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 30 Dec 2025
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Age 18:70 years
- RA patients with positive RF And Anti ccp
Who cannot join
- 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 .
Trial locations and contacts
No sites are listed yet.
About this study
Evaluation of muscle state in rheumatoid arthritis patients. Application of elastography in the detection of muscle stiffness in rheumatoid arthritis
Read the 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.
- Conditions
- Rheumatoid Arthritis, Musculoskeletal Ultrasound
- Being tested
- Musculoskeletal Ultrasound with elastography
- Keywords
- Muscle state
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Musculoskeletal Ultrasound with elastographyDevice
Musculoskeletal Ultrasound with elastography
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid arthritis patients | Not described Receives: Device: Musculoskeletal Ultrasound with elastography | |
| Healthy control group | Not described Receives: Device: Musculoskeletal Ultrasound with elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of muscle state in rheumatoid arthritis patients by using musculoskeletal us
Measured: Baseline
Secondary outcomes (1)
Application of elastography in the detection of muscle stiffness in rheumatoid arthritis patients
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Oct 2024 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Kamel Khedr Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620484
- Sponsor's protocol ID
- Musculoskeletal US in RA
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25294644Brennan 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.
PubMed 18982160Huffman 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.
PubMed 28114971Londhe P, Guttridge DC. Inflammation induced loss of skeletal muscle. Bone. 2015 Nov;80:131-142. doi: 10.1016/j.bone.2015.03.015.
PubMed 26453502
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musculoskeletal Ultrasound with Elastography in the Evaluation of Muscle State in Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT06620484
- Acronym / sponsor ID
- Musculoskeletal US in RA
- Conditions
- Rheumatoid Arthritis, Musculoskeletal Ultrasound
- Keywords
- Muscle state
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 1 Oct 2024 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid arthritis patients | – | Device: Musculoskeletal Ultrasound with elastography |
| Healthy control group | – | Device: Musculoskeletal Ultrasound with elastography |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Age 18:70 years
- RA patients with positive RF And Anti ccp
Key exclusion criteria (5 listed)
- 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 .
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 |
|---|---|---|
| Musculoskeletal Ultrasound with elastographyMusculoskeletal Ultrasound with elastography | Device | Healthy control group, Rheumatoid arthritis patients |
Primary outcome
Evaluation of muscle state in rheumatoid arthritis patients by using musculoskeletal us
Time frame: Baseline
1 secondary outcome
Application of elastography in the detection of muscle stiffness in rheumatoid arthritis patients
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Background: PubMed 25294644Frontera 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.
- Background: PubMed 18982160Brennan 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.
- Background: PubMed 28114971Huffman 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.
- Background: PubMed 26453502Londhe P, Guttridge DC. Inflammation induced loss of skeletal muscle. Bone. 2015 Nov;80:131-142. doi: 10.1016/j.bone.2015.03.015.
- Numbness, Muscle Pain, and Other RA SymptomsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 Rheumatoid Arthritis and Musculoskeletal Ultrasound, 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 5 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 1 Oct 2024. 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 Mostafa K Khedr, Resident (+201289452808, Teeefakamel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of muscle state in rheumatoid arthritis patients by using musculoskeletal us (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06620484, which also lists 4 linked publications.
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 1 Oct 2024.