Role of Musculoskeletal Ultrasound for Early Detection of Synovitis in SLE Patient and Its Correlation With Disease Activity and Neutrophil-to-C3 Ratio.

July 6, 2025 updated by: Mervat Sayed Kamal Sayed

Systemic lupus erythematosus (SLE) is a clinically common autoimmune disease characterized by abnormal immune response to autologous tissue, eventually resulting in systemic disorders and diverse clinical manifestations. The prevalence of women is significantly higher than that of men.

Musculoskeletal and joint affection represents one of the most common manifestations of systemic lupus erythematosus (SLE), and 95% of them have either arthralgia or arthritis during their disease course.

SLE arthropathy has main three different clinical types: nondeforming nonerosive arthritis; the most common type, deforming nonerosive arthropathy (Jaccoud's arthropathy) which has no bone erosions on conventional radiography and exists in up to 15% of the patients and erosive arthropathy (rhupus syndrome) which is overlap syndrome between rheumatoid arthritis (RA) and SLE and exist in <5% of lupus patients.

In clinical practice, most lupus patients who have joint and tendon pains often have no apparent inflammation during physical examination. Joint and tendon inflammation has been documented in musculoskeletal ultrasound in patients without any signs of arthritis, thus suggesting the role of ultrasound in the evaluation of patients with nonspecific musculoskeletal manifestations such as arthralgia. And detection of the presence of underlying subclinical inflammatory changes.

Components of lymphocytes, antibodies, inflammatory cytokines, and complements in peripheral circulation vary among different active stages of SLE. Patients with higher disease activity often damage tissues and organs, many of which even threaten life. It is of great significance in SLE management to early and accurately determine the disease activity of patients.

We will investigate the role of musculoskeletal ultrasound for early detection of synovitis in SLE patients and its correlation with disease activity and neutrophil-to-C3 ratio (NC3R).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

All participants will be subjected to full history taking, full clinical examination, laboratory investigations (complete blood count, erythrocyte sedimentation rate [ESR], C-reactive protein [CRP], blood urea, serum creatinine, serum glutamic-oxaloacetic transaminase [SGOT], serum glutamate-pyruvate transaminase [SGPT], immunological tests (antinuclear and anti-DNA antibodies and C3 and C4 levels), urine analysis, and 24-h urinary protein). SLE disease activity index (SELDAI) will be calculated for every patient.

Musculoskeletal examination with power Doppler, the ultrasound examination will be performed at the musculoskeletal ultrasonography unit at the rheumatology division of the internal medicine department. Bilateral musculoskeletal US examinations of hands and wrists with power Doppler (PD) evaluation will be done for all patients. US examinations were performed using the standardized scanning technique according to EULAR guidelines for musculoskeletal US in rheumatology.

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

non probability

Description

Inclusion Criteria:

  • SLE patients without musculoskeletal manifestations diagnosed according to European League against Rheumatism (EULAR) and the American college of Rheumatology (ACR)criteria for classification of SLE.

Exclusion Criteria:

  • • Overlap syndrome as rhupus patients, those with trauma, osteoarthritis, surgery of hand and wrist

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Role of musculoskeletal ultrasound for early detection of synovitis in SLE patient and its correlation with disease activity and neutrophil-to-C3 ratio.
Time Frame: baseline
early detection of synovitis in SLE patient
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 30, 2025

Primary Completion (Estimated)

October 25, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

July 6, 2025

First Submitted That Met QC Criteria

July 6, 2025

First Posted (Actual)

July 16, 2025

Study Record Updates

Last Update Posted (Actual)

July 16, 2025

Last Update Submitted That Met QC Criteria

July 6, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • musculoskeletal US SLE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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