Joint Ultrasound Evaluation of Asymptomatic Rheumatic Feet

Joint Ultrasound Evaluation of Asymptomatic Feet in Patients With Rheumatoid Arthritis: A Controlled Study

Objectives: The aims of the present study were to compare ultrasound on asymptomatic feet of patients with rheumatoid arthritis (RA) and normal controls, determine the association between ultrasound and global disease activity, function and goniometric measures in patients with RA and determine the correlation between ultrasound and radiography in the detection of bone erosion.

Methods: The foot joints (talocrural, talocalcaneal, talonavicular, naviculocuneiform, calcaneocuboid, 5th tarsometatarsal and 1st to 5th metatarsophalangeal [MTP] joints) of 50 healthy subjects and 50 patients with RA (all with asymptomatic feet) were evaluated bilaterally regarding quantitative/semi-quantitative synovitis, semi-quantitative Power Doppler (PD) signals and erosion using ultrasound. Statistical significance was set to 5%.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Brazil
  • SP - Sao Paulo
    • Sao Paulo, SP - Sao Paulo, Brazil, 04023-062
      • Universidade Federal de Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Rheumatoid Arthritis

Description

Inclusion Criteria:

Rheumatoid Arthritis Group:

• RA with at least one year since diagnosis
• Asymptomatic feet
• Age between 18 and 65 years Control group
• absence of known osteoarticular disease

Exclusion Criteria for both groups:

• Peripheral venous insufficiency with retrograde venous flow and/or ochre dermatitis
• Previous surgical intervention and/or fracture in feet/ankles
• Intra-articular corticosteroid injection in previous three months in any of the joints evaluated
• Foot neuropathy
• Pain and swelling in feet or ankles

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Rheumatoid Arthritis Group; RA with at least one year since diagnosis, asymptomatic feet, and age between 18 and 65 years
Control group; Absence of known osteoarticular disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of synovial effusion and/or synovial hypertrophy	Ultrasound evaluation - quantitative measurement considered the distance between the joint capsule and subchondral bone of the joints studied (talocrural, talocalcaneal (medial, lateral and posterior windows); dorsal face of calcaneocuboid, talonavicular, medial naviculocuneiform, 5th tarsometatarsal and metatarsophalangeal (MTP) (dorsal and volar faces of 1st to 5th MTP joints and lateral face of 1st and 5th MTP joints). A modified score was used for the semi-quantitative measurement, ranging from 0 to 3: 0-no synovial thickening; 1-minimal synovial thickening in joint recess; 2-synovial thickening in entire joint recess causing bulging of joint capsule; and 3-synovial thickening in joint recess with bulging of joint capsule and extending to at least one bone diaphysis. "Presence of synovitis" was defined as synovial hypertrophy of at least Grade 1 in the semi-quantitative analysis (gray scale - ultrasound)	Baseline
Presence of bone erosion	defined based on the preliminary OMERACT criteria: intra-articular discontinuity of the bone surface observed on two perpendicular planes. A previously established semi-quantitative score (0-3) was employed: 0-uniform bone surface; 1-irregular bone surface; 2-bone surface defect on two planes; 3-bone defect causing extensive bone destruction. The "presence of erosion" was defined as the presence of at least Grade 2 erosion.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic evaluation	A blinded radiologist analysed the presence of erosion in each joint studied. For such, ankle (AP and profile) and foot (AP and profile with load) radiographs were taken.	Baseline
Intraobserver and interobserver agreement	The patients with RA were submitted to clinical and ultrasound evaluations of the feet and ankles on the same day. The ultrasound measurements intraobserver/interobserver agreement was performed on the talocrural, talonavicular and 5th MTP joints, using 20% of the sample. For this, the ultrasound exams were performed by another rheumatologist.	Baseline
Presence of synovial blood flow	The presence of Power Doppler (PD) signals was evaluated in the bone margins, joint spaces, and peri-articular tissues (frequency of 8 MHz and pulse repetition rate of 750 MHz). A semi-quantitative score (0-3) was employed[14]: 0-no signal; 1-minimal signal, presence of simple vessels; 2-moderate signal, presence of confluent vessels with signal in less than 50% of the area evaluated; 3-intense signal (more than 50% of area evaluated). "Active synovitis" or "presence of PD signal" was defined as the presence of intra-articular synovitis with a positive PD signal (at least Grade 1).	Baseline

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Investigators: Principal Investigator: Rita Furtado, MD, Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: August 27, 2012
• First Submitted That Met QC Criteria: August 29, 2012
• First Posted (Estimate): September 3, 2012

Study Record Updates

• Last Update Posted (Estimate): September 3, 2012
• Last Update Submitted That Met QC Criteria: August 29, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Ultrasonography; Rheumatoid arthritis; Synovitis; Foot joints
• 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: UNIFESP/2011