NCT02324192

Brief Summary

Objective: To evaluate the correlation / association between inflammatory ultrasonography findings and clinical /functional assessment in symptomatic hand OA interphalangeal joints (IP). To evaluate the intra and interobserver reproducibility of ultrasound findings. Methods: It was conducted a prospective study in 60 symptomatic hand OA patients. They were assessed in six times (T0, T1, T4, T8, T12 and T48 weeks) by "blind" observers (clinical and ultrasonography). The intra and interobserver reproducibility analysis was performed in 25% of the sample. Differences were considered as statistically significant when p\< 0.05.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 24, 2014

Completed
Last Updated

December 24, 2014

Status Verified

December 1, 2014

Enrollment Period

1 year

First QC Date

December 9, 2014

Last Update Submit

December 23, 2014

Conditions

Osteoarthritis

Keywords

Ultrasonographyclinicalhand

Outcome Measures

Primary Outcomes (1)

  • Change from baseline - Correlation between VASr(Visual Analogic Scale of pain at rest 0-10cm) and ultrasonography findings(Grey Scale and power Doppler) at 1year in six times

    0,1,4,8,12 and 48 weeks

Secondary Outcomes (7)

  • Change from baseline - Correlation between VASs(Visual Analogic Scale of joint swelling 0-10cm) and ultrasonography findings(determined using the Grey Scale and power Doppler in affected joint)) at 1year in six times

    0,1,4,8,12 and 48 weeks

  • Change from baseline - Correlation between joint goniometry(°) and ultrasonography findings ( determined using the Grey Scale and power Doppler in affected joint) at 1year in six times

    0,1,4,8,12 and 48 weeks

  • Change from baseline - Correlation between use of analgesics(tablets per day of paracetamol) and ultrasonography findings(determined using the Grey Scale and power Doppler in affected joint) at 1year in six times

    0,1,4,8,12 and 48 weeks

  • Change from baseline - Correlation between handgrip strength determined by Jamar dynamometer grip(kgf) and ultrasonography findings(determined using the Grey Scale and power Doppler in affected joint) at 1year in six times

    0,1,4,8,12 and 48 weeks

  • Change from baseline - Correlation between pinch strength determined by the dynamometer of Pinch Gauge(kgf) and ultrasonography findings(determined using the Grey Scale and power Doppler in affected joint) at 1year in six times

    0,1,4,8,12 and 48 weeks

  • +2 more secondary outcomes

Study Arms (2)

Normal ultrasonography

OTHER

Patients with normal ultrasonography findings

Other: Ultrasonography

Inflammatory ultrasonography

OTHER

Patients with inflammatory ultrasonography findings

Other: Ultrasonography

Interventions

UltrasonographyOTHER

imaging findings

Inflammatory ultrasonographyNormal ultrasonography

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of hand OA, according to the criteria of the American College of Rheumatology (ACR) (Altman et al., 1990) with involvement of proximal and / or distal IP joints
  • More than 40 years old
  • Visual analog scale of pain (VAS of 0-10 cm) in the joint of study between 3-8cm
  • And agree and sign the Consent Term of the study.

You may not qualify if:

  • Changed the use of oral corticosteroids and nonsteroidal anti-inflammatory drugs in the last thirty days
  • Changed the treatment of OA in the last two months (including drug and rehabilitation)
  • Radiography of hands suggesting interphalangeal arthropathy of other etiology (psoriatic arthritis, microcrystalline arthropathy).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rheumatology of Federal University of São Paulo

São Paulo, São Paulo, 04024-002, Brazil

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Rita NV Furtado, PhD

    Federal University of São Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 9, 2014

First Posted

December 24, 2014

Study Start

August 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2014

Last Updated

December 24, 2014

Record last verified: 2014-12

Locations

BR(1)