Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00414427
Status:
COMPLETED
Last Update Posted:
2010-07-08
First Post:
2006-12-20
Brief Title:
Using Ultrasonography to Predict Clinical Response to Intraarticular Corticosteroids in Knee Osteoarthritis
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Using Ultrasonography to Predict Clinical Response to Intraarticular Corticosteroids in Knee Osteoarthritis
Status:
COMPLETED
Status Verified Date:
2006-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None