Knee Osteoarthritis Clinical Trial
Official title:
Using Ultrasonography to Predict Clinical Response to Intraarticular Corticosteroids in Knee Osteoarthritis
The primary purposes of this study are the following:
1. 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.
2. To prospectively evaluate clinical responsiveness of intraarticular corticosteroids
with the inflammatory phenotype of knee OA using a randomized, placebo controlled
clinical design.
3. 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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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