Osteoarthritis
Conditions
Keywords
osteoarthritis, knee, corticosteroids, ultrasound
Brief 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.
Interventions
DRUGtriamcinolone acetonide
single intraarticular injection of 40 mg of triamcinolone acetonide
DRUGsaline
Single intraarticular injection of 1 ml of 0.9% saline
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Western Ontario and McMasters Universities Arthritis Index (WOMAC) Pain Subscale | baseline to 4 weeks | WOMAC pain subscale range 0-20 (0=best, 20=worst) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in WOMAC Pain Subscale | baseline to 12 weeks | WOMAC pain subscale range 0-20 (0=best, 20=worst) |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Corticosteroid Injection 40 mg of intraarticular triamcinolone acetonide | 40 |
| Placebo Intraarticular injection of 0.9% saline | 39 |
| Total | 79 |
Baseline characteristics
| Characteristic | Placebo | Corticosteroid Injection | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 16 Participants | 16 Participants | 32 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 24 Participants | 47 Participants |
| Age Continuous | 63 years STANDARD_DEVIATION 12 | 64 years STANDARD_DEVIATION 12 | 63 years STANDARD_DEVIATION 12 |
| Region of Enrollment United States | 39 participants | 40 participants | 79 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 37 Participants | 39 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 39 |
| serious Total, serious adverse events | 0 / 40 | 0 / 39 |
Outcome results
Primary
Change in Western Ontario and McMasters Universities Arthritis Index (WOMAC) Pain Subscale
WOMAC pain subscale range 0-20 (0=best, 20=worst)
Time frame: baseline to 4 weeks
Population: This population was defined as patients who completed the 4 week follow up assessment as per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corticosteroid Injection | Change in Western Ontario and McMasters Universities Arthritis Index (WOMAC) Pain Subscale | -2.1 units on a scale | Standard Deviation 2.6 |
| Placebo | Change in Western Ontario and McMasters Universities Arthritis Index (WOMAC) Pain Subscale | -0.1 units on a scale | Standard Deviation 1.9 |
Other Pre-specified
Change in WOMAC Pain Subscale
WOMAC pain subscale range 0-20 (0=best, 20=worst)
Time frame: baseline to 12 weeks
Population: These patients were categorized as inflammatory or noninflammatory based on the baseline ultrasound characteristics. All patients were in the treatment group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corticosteroid Injection | Change in WOMAC Pain Subscale | -0.1 units on a scale | Standard Deviation 3.2 |
| Placebo | Change in WOMAC Pain Subscale | -2.0 units on a scale | Standard Deviation 1.8 |