Joint Ultrasound Evaluation of Asymptomatic Rheumatic Feet

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anamaria Jones, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01677416
First received: August 27, 2012
Last updated: August 29, 2012
Last verified: August 2012
  Purpose

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%.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Joint Ultrasound Evaluation of Asymptomatic Feet in Patients With Rheumatoid Arthritis: A Controlled Study

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Presence of synovial effusion and/or synovial hypertrophy [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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)

  • Presence of bone erosion [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Radiographic evaluation [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Intraobserver and interobserver agreement [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Presence of synovial blood flow [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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).


Enrollment: 100
Study Start Date: March 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Rheumatoid Arthritis

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01677416

Locations
Brazil
Universidade Federal de Sao Paulo
Sao Paulo, SP - Sao Paulo, Brazil, 04023-062
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Rita Furtado, MD Federal University of São Paulo
  More Information

No publications provided

Responsible Party: Anamaria Jones, Principal Investigator, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01677416     History of Changes
Other Study ID Numbers: UNIFESP/2011
Study First Received: August 27, 2012
Last Updated: August 29, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
Rheumatoid arthritis
Ultrasonography
Synovitis
Foot joints

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 23, 2014