Musculoskeletal Ultrasound for Differentiating Rheumatoid and Gouty Arthritis

June 14, 2026 updated by: Kiroles Bassem Fikrey Ramzy, Assiut University

Role of Musculoskeletal Ultrasound in Differentiation of Rheumatoid Arthritis and Gouty Arthritis Using Semi-Quantitative Scoring

Rheumatoid arthritis (RA) and gouty arthritis (GA) are two common forms of joint inflammation that can present with very similar physical symptoms, making them difficult to tell apart early in the disease process. Accurate and early differentiation is crucial because the treatment strategies and long-term management for the two conditions are substantially different.

The primary purpose of this observational study is to evaluate the diagnostic performance of musculoskeletal ultrasound (MSUS) in distinguishing between RA and GA. Ultrasound is a safe, radiation-free imaging tool that can visualize joint inflammation and structural changes in real-time. This study utilizes a structured semi-quantitative scoring system (graded on a scale of 0 to 3) to systematically measure the severity of joint lining thickness (synovial hypertrophy) and active blood flow (power Doppler signal). It also checks for crystal-related deposits, such as tophi or the double contour sign, which are highly suggestive of gout.

Participants aged 18 and older with suspected or confirmed RA or GA who are referred for joint assessment at Assiut University Hospitals will undergo a standard clinical evaluation, routine laboratory testing, and an ultrasound examination of specific target joints (such as the wrists, hands, knees, and ankles). By comparing the ultrasound scores and specific structural findings between the two patient groups, the study aims to establish a reliable, standardized imaging approach to help physicians make faster, more confident diagnoses and initiate the correct disease-specific therapies sooner.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The study population consists of adult patients, aged 18 years or older, of either sex. It includes individuals presenting with clinically suspected or confirmed rheumatoid arthritis or gouty arthritis. These participants are specifically those referred to the radiology department at Assiut University Hospitals in Assiut, Egypt, for a musculoskeletal ultrasound assessment of painful, swollen, or inflamed joints.

Description

Inclusion Criteria:

  • Patients aged 18 years or older.
  • Either sex.
  • Patients with clinically suspected or confirmed rheumatoid arthritis.
  • Patients with clinically suspected or confirmed gouty arthritis.
  • Patients referred for musculoskeletal ultrasound assessment of painful, swollen, or inflamed joints.
  • Patients able and willing to provide informed consent.
  • Patients whose final diagnosis is established by clinical assessment, laboratory testing, and/or relevant imaging or synovial fluid analysis when available.

Exclusion Criteria:

  • Patients younger than 18 years.
  • Patients with septic arthritis or suspected joint infection.
  • Patients with traumatic joint injury involving the target joint.
  • Patients with other inflammatory arthropathies such as psoriatic arthritis, reactive arthritis, or systemic lupus erythematosus if they may confound imaging interpretation.
  • Patients with advanced osteoarthritis in the scanned joint if it markedly limits Faculty of Medicine Institutional Review Board (IRB) Assiut Medical School Research Proposal Form 5 interpretation.
  • Patients with incomplete clinical records or insufficient ultrasound windows.
  • Patients who refuse consent.
  • Patients whose diagnosis remains uncertain after clinical workup.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Rheumatoid Arthritis Cohort
Patients aged 18 years or older presenting with clinically suspected or confirmed rheumatoid arthritis. Participants undergo standard clinical and laboratory assessment followed by a musculoskeletal ultrasound examination of target joints (including wrists, metacarpophalangeal joints, proximal interphalangeal joints, knees, and ankles). The ultrasound evaluates the presence and severity of gray-scale synovitis, power Doppler vascularity, joint effusion, and bone erosions using a 0-3 semi-quantitative scoring system.
Gouty Arthritis Cohort
Patients aged 18 years or older presenting with clinically suspected or confirmed gouty arthritis. Participants undergo standard clinical and laboratory assessment followed by a musculoskeletal ultrasound examination of target joints, particularly the first metatarsophalangeal joint and other symptomatic areas. The ultrasound applies a semi-quantitative scoring system to evaluate inflammatory changes and specifically targets crystal-related findings, including the double contour sign, tophus formation, hyperechoic aggregates, and erosions with overhanging edges.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Semi-quantitative Gray-Scale Synovitis Score
Time Frame: Baseline (Single assessment at the time of the cross-sectional ultrasound examination)
Synovial hypertrophy evaluated using high-resolution musculoskeletal ultrasound, graded on a 0 to 3 scale where 0 indicates no synovial thickening, 1 indicates mild synovial hypertrophy, 2 indicates moderate synovial hypertrophy, and 3 indicates severe synovial hypertrophy.
Baseline (Single assessment at the time of the cross-sectional ultrasound examination)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Semi-quantitative Power Doppler Synovitis Score
Time Frame: Baseline (Single assessment)
Synovial vascularity evaluated using high-resolution musculoskeletal ultrasound, graded on a 0 to 3 scale where 0 indicates no Doppler signal, 1 indicates a mild signal, 2 indicates a moderate signal, and 3 indicates marked Doppler activity.
Baseline (Single assessment)
Presence of Double Contour Sign
Time Frame: Baseline (Single assessment)
The frequency of the double contour sign, representing urate crystal deposits on the articular cartilage, detected via musculoskeletal ultrasound in the target joints.
Baseline (Single assessment)
Presence of Tophi
Time Frame: Baseline (Single assessment)
The frequency of tophus formation, identified as hyperechoic aggregates, detected via musculoskeletal ultrasound in the target joints.
Baseline (Single assessment)
Frequency of Bone Erosions
Time Frame: Baseline (Single assessment)
The presence and frequency of bone erosions detected via musculoskeletal ultrasound in the target joints.
Baseline (Single assessment)
Frequency of Tenosynovitis
Time Frame: Baseline (Single assessment)
The presence and frequency of tenosynovitis detected via musculoskeletal ultrasound in the target joints.
Baseline (Single assessment)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • US Scoring: RA vs Gout

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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