Joint Ultrasound Evaluation of Asymptomatic Rheumatic Feet

NCT01677416 | Completed

• 1 other identifier: UNIFESP/2011
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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%.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis; Ultrasonography; Synovitis; Foot joints

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Radiographic evaluation

  Baseline

• Intraobserver and interobserver agreement

  Baseline

• Presence of synovial blood flow

  Baseline

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Rheumatoid Arthritis

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Universidade Federal de Sao Paulo

São Paulo, SP - Sao Paulo, 04023-062, Brazil

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Synovitis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Rita Furtado, MD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 27, 2012
• First Posted: September 3, 2012
• Study Start: March 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: September 3, 2012

Record last verified: 2012-08

Locations

BR (1)