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| Sponsored by: |
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:
We 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: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Using Ultrasonography to Predict Clinical Response to Intraarticular Corticosteroids in Knee Osteoarthritis |
| Estimated Enrollment: | 120 |
| Study Start Date: | December 2005 |
| Estimated Study Completion Date: | June 2007 |
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 | |
| La Jolla Veterans Affairs Medical Center | Recruiting |
| San Diego, California, United States, 92161 | |
| Contact: Kenneth Kalunian, M.D. 858-657-7051 kkalunian@ucsd.edu | |
| Principal Investigator: Kenneth Kalunian, M.D. | |
| Thorton Hospital | Recruiting |
| La Jolla, California, United States, 92037 | |
| Contact: Kenneth Kalunian, M.D. 858-657-7049 kkalunian@ucsd.edu | |
| Principal Investigator: Kenneth Kalunian, M.D. | |
| Principal Investigator: | Kenneth Kalunian, M.D. | Univeristy of California at San Diego |
More Information
| Study ID Numbers: | 051420 |
| Study First Received: | December 20, 2006 |
| Last Updated: | December 20, 2006 |
| ClinicalTrials.gov Identifier: | NCT00414427 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Knee Osteoarthritis Ultrasonography Corticosteroids |
|
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis |
Joint Diseases Arthritis Rheumatic Diseases |
|
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis |
Joint Diseases Arthritis Rheumatic Diseases |