Using Ultrasound to Predict Response to Intraarticular Corticosteroids in Knee Osteoarthritis

Osteoarthritis Clinical Trial

Official title:

Using Ultrasound to Predict Response to Intraarticular Corticosteroids in Knee Osteoarthritis: A Randomized Placebo-Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00746889
• Other study ID #: IRB 051420
• Status: Completed
• Phase: N/A
• First received: September 3, 2008
• Last updated: July 29, 2010
• Start date: March 2004
• Est. completion date: September 2008

Study information

• Verified date: September 2008
• 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

A study using characteristics on ultrasound to predict response to intraarticular steroid injections in patients with knee osteoarthritis. The hypothesis is that patients with inflammation on ultrasound will have a better response to corticosteroid injections compared to patients without inflammation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: September 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• knee pain

• diagnosis of osteoarthritis in affected knee

Exclusion Criteria:

• intraarticular corticosteroids in affected knee within past three months

• primary inflammatory connective tissue disease (ie rheumatoid arthritis)

• currently taking oral corticosteroids

Study Design

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• triamcinolone acetonide
single intraarticular injection of 40 mg of triamcinolone acetonide
• saline
Single intraarticular injection of 1 ml of 0.9% saline

Locations

Country	Name	City	State
United States	San Diego VA Hospital	La Jolla	California
United States	University of California San Diego Medical Center	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Western Ontario and McMasters Universities Arthritis Index (WOMAC) Pain Subscale	WOMAC pain subscale range 0-20 (0=best, 20=worst)	baseline to 4 weeks	No