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Using Ultrasound to Predict Response to Intraarticular Corticosteroids in Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT00746889
Recruitment Status : Completed
First Posted : September 4, 2008
Results First Posted : August 25, 2010
Last Update Posted : August 25, 2010
Sponsor:
Information provided by:
University of California, San Diego

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Osteoarthritis
Interventions Drug: triamcinolone acetonide
Drug: saline
Enrollment 79
Recruitment Details Patients were recruited in rheumatology clinics at UCSD and the VA musculoskeletal clinic.
Pre-assignment Details Patients taking oral corticosteroids, who had a primary inflammatory connective tissue disease, or who received IA corticosteroids in the affected knee within three months of study entry were excluded from the study.
Arm/Group Title Corticosteroid Injection Placebo
Hide Arm/Group Description 40 mg of intraarticular triamcinolone acetonide Intraarticular injection of 0.9% saline
Period Title: Overall Study
Started 40 39
Completed 36 35
Not Completed 4 4
Arm/Group Title Corticosteroid Injection Placebo Total
Hide Arm/Group Description 40 mg of intraarticular triamcinolone acetonide Intraarticular injection of 0.9% saline Total of all reporting groups
Overall Number of Baseline Participants 40 39 79
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 39 participants 79 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
24
  60.0%
23
  59.0%
47
  59.5%
>=65 years
16
  40.0%
16
  41.0%
32
  40.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 39 participants 79 participants
64  (12) 63  (12) 63  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 39 participants 79 participants
Female
1
   2.5%
2
   5.1%
3
   3.8%
Male
39
  97.5%
37
  94.9%
76
  96.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants 39 participants 79 participants
40 39 79
1.Primary Outcome
Title Change in Western Ontario and McMasters Universities Arthritis Index (WOMAC) Pain Subscale
Hide Description WOMAC pain subscale range 0-20 (0=best, 20=worst)
Time Frame baseline to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This population was defined as patients who completed the 4 week follow up assessment as per protocol.
Arm/Group Title Corticosteroid Injection Placebo
Hide Arm/Group Description:
40 mg of intraarticular triamcinolone acetonide
Intraarticular injection of 0.9% saline
Overall Number of Participants Analyzed 33 34
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.1  (2.6) -0.1  (1.9)
2.Other Pre-specified Outcome
Title Change in WOMAC Pain Subscale
Hide Description WOMAC pain subscale range 0-20 (0=best, 20=worst)
Time Frame baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
These patients were categorized as inflammatory or noninflammatory based on the baseline ultrasound characteristics. All patients were in the treatment group.
Arm/Group Title Inflammatory Patients Who Received Corticosteroid Injections Noninflammatory Patients Who Received Corticosteroid Injection
Hide Arm/Group Description:
Patients with inflammatory characteristics on ultrsaound who were treated with corticosteroid knee injections
Patients with noninflammatory characteristics on ultrasound who received saline placebo knee injections
Overall Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.1  (3.2) -2.0  (1.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Corticosteroid Injection Placebo
Hide Arm/Group Description 40 mg of intraarticular triamcinolone acetonide Intraarticular injection of 0.9% saline
All-Cause Mortality
Corticosteroid Injection Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Corticosteroid Injection Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/39 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Corticosteroid Injection Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/39 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jeannie Chao
Organization: UCSD
Phone: 858-657-7040
Responsible Party: Kenneth Kalunian, University of California San Diego
ClinicalTrials.gov Identifier: NCT00746889     History of Changes
Other Study ID Numbers: IRB 051420
First Submitted: September 3, 2008
First Posted: September 4, 2008
Results First Submitted: April 5, 2010
Results First Posted: August 25, 2010
Last Update Posted: August 25, 2010