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| Sponsor: | University of California, San Diego |
|---|---|
| Information provided by: | University of California, San Diego |
| ClinicalTrials.gov Identifier: | NCT00414427 |
Purpose
The primary purposes of this study are the following:
The investigators hypothesize that patients with signs of inflammation by ultrasonography such as synovitis and effusion will respond better to intraarticular corticosteroid injection.
| Condition | Intervention |
|---|---|
|
Knee Osteoarthritis |
Procedure: Intraarticular steroids |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Using Ultrasonography to Predict Clinical Response to Intraarticular Corticosteroids in Knee Osteoarthritis |
| Estimated Enrollment: | 120 |
| Study Start Date: | December 2005 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Thorton Hospital | |
| La Jolla, California, United States, 92037 | |
| La Jolla Veterans Affairs Medical Center | |
| San Diego, California, United States, 92161 | |
| Principal Investigator: | Kenneth Kalunian, M.D. | Univeristy of California at San Diego |
More Information
| Responsible Party: | Kenneth Kalunian, M.D., Professor of Medicine, UCSD |
| ClinicalTrials.gov Identifier: | NCT00414427 History of Changes |
| Other Study ID Numbers: | 051420 |
| Study First Received: | December 20, 2006 |
| Last Updated: | July 7, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
Knee Osteoarthritis Ultrasonography Corticosteroids |
|
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |