search
Back to results

Using Ultrasonography to Predict Clinical Response to Intraarticular Corticosteroids in Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

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

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee Osteoarthritis, Ultrasonography, Corticosteroids

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Both male and female patients are eligible for the study if they are between 40 and 80 years old, have symptomatic knee OA requiring treatment, and have not responded adequately to treatment with acetominophen or NSAIDs.

Exclusion Criteria:

  • Severe OA as defined by radiographic Kellgren and Lawrence Grade IV
  • The patient being wheel-chair bound
  • Previous knee operation on the affected side within the past year or history of total knee arthroplasty (affected side)
  • Any IA steroid or injections in the last 3 months or viscosupplementation in the last 6 months
  • Local sepsis
  • Local skin conditions
  • Serious concomitant medical illness.

Sites / Locations

  • Thorton Hospital
  • La Jolla Veterans Affairs Medical Center

Outcomes

Primary Outcome Measures

To evaluate whether the presence of inflammatory knee osteoarthritis as determined by ultrasonography can be used as a clinical predictor of patient response to intra-articular corticosteroids.
To prospectively evaluate clinical responsiveness of intraarticular corticosteroids with the inflammatory phenotype of knee OA using a randomized, placebo controlled clinical design.

Secondary Outcome Measures

To evaluate whether lower extremity strength is improved with intraarticular corticosteroid injection.

Full Information

First Posted
December 20, 2006
Last Updated
July 7, 2010
Sponsor
University of California, San Diego
search

1. Study Identification

Unique Protocol Identification Number
NCT00414427
Brief Title
Using Ultrasonography to Predict Clinical Response to Intraarticular Corticosteroids in Knee Osteoarthritis
Official Title
Using Ultrasonography to Predict Clinical Response to Intraarticular Corticosteroids in Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, San Diego

4. Oversight

5. Study Description

Brief Summary
The primary purposes of this study are the following: To evaluate whether the presence of inflammatory knee osteoarthritis as determined by ultrasonography can be used as a clinical predictor of patient response to intra-articular corticosteroids. To prospectively evaluate clinical responsiveness of intraarticular corticosteroids with the inflammatory phenotype of knee OA using a randomized, placebo controlled clinical design. To evaluate whether lower extremity strength is improved with intraarticular corticosteroid injection. The investigators hypothesize that patients with signs of inflammation by ultrasonography such as synovitis and effusion will respond better to intraarticular corticosteroid injection.
Detailed Description
Osteoarthritis (OA) has previously been thought to be a non-inflammatory condition whose pathologic hallmark is destruction of hyaline cartilage. It is now realized that OA results from a complex interplay of multiple factors, including local inflammatory processes. Evidence suggests that synovitis which is the usual presenting sign of inflammatory arthritis is also frequently present in OA. The presence of inflammation in knee OA may explain why intra-articular (IA) corticosteroid injections have been shown to result in clinically and statistically significant reduction in osteoarthritic knee pain. Randomized controlled trials have shown that treated patients were less likely to have continuing pain and had significantly lower scores on a visual analogue scale (VAS) for pain. However, studies have failed to determine clinical predictors of response to IA steroid injection, including traditional indices of inflammation (heat, fluid, stiffness). One possibility is that local corticosteroids do no act to relieve pain by reducing synovitis. These putative mechanisms have yet to be elucidated. Perhaps a more plausible explanation is that current methods of assessing local inflammation in OA are inadequate. Recent studies involving ultrasonography (US) demonstrate that US is a valid and reproducible tool for the detection of synovitis in the knee. It has been shown to be more sensitive than clinical examination and is relatively inexpensive and noninvasive.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee Osteoarthritis, Ultrasonography, Corticosteroids

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Intraarticular steroids
Primary Outcome Measure Information:
Title
To evaluate whether the presence of inflammatory knee osteoarthritis as determined by ultrasonography can be used as a clinical predictor of patient response to intra-articular corticosteroids.
Title
To prospectively evaluate clinical responsiveness of intraarticular corticosteroids with the inflammatory phenotype of knee OA using a randomized, placebo controlled clinical design.
Secondary Outcome Measure Information:
Title
To evaluate whether lower extremity strength is improved with intraarticular corticosteroid injection.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Both male and female patients are eligible for the study if they are between 40 and 80 years old, have symptomatic knee OA requiring treatment, and have not responded adequately to treatment with acetominophen or NSAIDs. Exclusion Criteria: Severe OA as defined by radiographic Kellgren and Lawrence Grade IV The patient being wheel-chair bound Previous knee operation on the affected side within the past year or history of total knee arthroplasty (affected side) Any IA steroid or injections in the last 3 months or viscosupplementation in the last 6 months Local sepsis Local skin conditions Serious concomitant medical illness.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Kalunian, M.D.
Organizational Affiliation
Univeristy of California at San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thorton Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
La Jolla Veterans Affairs Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15000335
Citation
Godwin M, Dawes M. Intra-articular steroid injections for painful knees. Systematic review with meta-analysis. Can Fam Physician. 2004 Feb;50:241-8. Erratum In: Can Fam Physician. 2009 Jun;55(6):590.
Results Reference
background
PubMed Identifier
7794044
Citation
Gaffney K, Ledingham J, Perry JD. Intra-articular triamcinolone hexacetonide in knee osteoarthritis: factors influencing the clinical response. Ann Rheum Dis. 1995 May;54(5):379-81. doi: 10.1136/ard.54.5.379.
Results Reference
background
PubMed Identifier
11229463
Citation
Walther M, Harms H, Krenn V, Radke S, Faehndrich TP, Gohlke F. Correlation of power Doppler sonography with vascularity of the synovial tissue of the knee joint in patients with osteoarthritis and rheumatoid arthritis. Arthritis Rheum. 2001 Feb;44(2):331-8. doi: 10.1002/1529-0131(200102)44:23.0.CO;2-0.
Results Reference
background
PubMed Identifier
14872480
Citation
Karim Z, Wakefield RJ, Quinn M, Conaghan PG, Brown AK, Veale DJ, O'Connor P, Reece R, Emery P. Validation and reproducibility of ultrasonography in the detection of synovitis in the knee: a comparison with arthroscopy and clinical examination. Arthritis Rheum. 2004 Feb;50(2):387-94. doi: 10.1002/art.20054.
Results Reference
background
PubMed Identifier
8976640
Citation
Jones A, Doherty M. Intra-articular corticosteroids are effective in osteoarthritis but there are no clinical predictors of response. Ann Rheum Dis. 1996 Nov;55(11):829-32. doi: 10.1136/ard.55.11.829.
Results Reference
background

Learn more about this trial

Using Ultrasonography to Predict Clinical Response to Intraarticular Corticosteroids in Knee Osteoarthritis

We'll reach out to this number within 24 hrs