search
Back to results

Using Ultrasound to Predict Response to Intraarticular Corticosteroids in Knee Osteoarthritis

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
triamcinolone acetonide
saline
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring osteoarthritis, knee, corticosteroids, ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • knee pain
  • diagnosis of osteoarthritis in affected knee

Exclusion Criteria:

  • intraarticular corticosteroids in affected knee within past three months
  • primary inflammatory connective tissue disease (ie rheumatoid arthritis)
  • currently taking oral corticosteroids

Sites / Locations

  • University of California San Diego Medical Center
  • San Diego VA Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Corticosteroid Injection

Placebo Injection

Arm Description

40 mg of intraarticular triamcinolone acetonide

Intraarticular injection of 0.9% saline

Outcomes

Primary Outcome Measures

Change in Western Ontario and McMasters Universities Arthritis Index (WOMAC) Pain Subscale
WOMAC pain subscale range 0-20 (0=best, 20=worst)

Secondary Outcome Measures

Full Information

First Posted
September 3, 2008
Last Updated
July 29, 2010
Sponsor
University of California, San Diego
search

1. Study Identification

Unique Protocol Identification Number
NCT00746889
Brief Title
Using Ultrasound to Predict Response to Intraarticular Corticosteroids in Knee Osteoarthritis
Official Title
Using Ultrasound to Predict Response to Intraarticular Corticosteroids in Knee Osteoarthritis: A Randomized Placebo-Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, San Diego

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A study using characteristics on ultrasound to predict response to intraarticular steroid injections in patients with knee osteoarthritis. The hypothesis is that patients with inflammation on ultrasound will have a better response to corticosteroid injections compared to patients without inflammation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
osteoarthritis, knee, corticosteroids, ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Corticosteroid Injection
Arm Type
Active Comparator
Arm Description
40 mg of intraarticular triamcinolone acetonide
Arm Title
Placebo Injection
Arm Type
Placebo Comparator
Arm Description
Intraarticular injection of 0.9% saline
Intervention Type
Drug
Intervention Name(s)
triamcinolone acetonide
Intervention Description
single intraarticular injection of 40 mg of triamcinolone acetonide
Intervention Type
Drug
Intervention Name(s)
saline
Intervention Description
Single intraarticular injection of 1 ml of 0.9% saline
Primary Outcome Measure Information:
Title
Change in Western Ontario and McMasters Universities Arthritis Index (WOMAC) Pain Subscale
Description
WOMAC pain subscale range 0-20 (0=best, 20=worst)
Time Frame
baseline to 4 weeks
Other Pre-specified Outcome Measures:
Title
Change in WOMAC Pain Subscale
Description
WOMAC pain subscale range 0-20 (0=best, 20=worst)
Time Frame
baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: knee pain diagnosis of osteoarthritis in affected knee Exclusion Criteria: intraarticular corticosteroids in affected knee within past three months primary inflammatory connective tissue disease (ie rheumatoid arthritis) currently taking oral corticosteroids
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Kalunian, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anna Quan, MD
Organizational Affiliation
San Diego VA Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Michal Kalli Hose, MD
Organizational Affiliation
San Diego VA Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jeannie Chao, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Study Director
Facility Information:
Facility Name
University of California San Diego Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
San Diego VA Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92161
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Using Ultrasound to Predict Response to Intraarticular Corticosteroids in Knee Osteoarthritis

We'll reach out to this number within 24 hrs