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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00414427
• Other study ID #: 051420
• Status: Completed
• Phase: N/A
• First received: December 20, 2006
• Last updated: July 7, 2010
• Start date: December 2005
• Est. completion date: June 2009

Study information

• Verified date: December 2006
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Intraarticular steroids

Locations

Country	Name	City	State
United States	Thorton Hospital	La Jolla	California
United States	La Jolla Veterans Affairs Medical Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. Review. Erratum in: Can Fam Physician. 2009 Jun;55(6):590. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	To prospectively evaluate clinical responsiveness of intraarticular corticosteroids with the inflammatory phenotype of knee OA using a randomized, placebo controlled clinical design.
Secondary	To evaluate whether lower extremity strength is improved with intraarticular corticosteroid injection.