Joint Ultrasound Evaluation of Asymptomatic Rheumatic Feet

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01677416
• Other study ID #: UNIFESP/2011
• Status: Completed
• Phase: N/A
• First received: August 27, 2012
• Last updated: August 29, 2012
• Start date: March 2011
• Est. completion date: March 2012

Study information

• Verified date: August 2012
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Brazil	Universidade Federal de Sao Paulo	Sao Paulo	SP - Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No