Knee Arthritis Osteoarthritis
Conditions
Brief summary
The purpose of this study is to determine whether a lower dose of corticosteroid injection with ultrasound-guidance for the treatment of knee osteoarthritis can be as effective as a higher dose that is landmark-guided. With landmark-guided dosing, it may be reasonable to use a higher amount of corticosteroid in order to ensure a sufficient amount of the medication is administered, however these injections carry the risk of side effects. Alternatively, with the use of ultrasound, it may be reasonable to use less corticosteroid, possibly decreasing the risk of side effects and increasing patient satisfaction.
Interventions
DRUGTriamcinolone knee injection without ultrasound guidance
3mL lidocaine (without epinephrine) 1% solution combined with 1mL triamcinolone acetonide injectable solution, USP (40mg per mL)
COMBINATION_PRODUCTTriamcinolone knee injection with ultrasound guidance
3mL lidocaine (without epinephrine) 1% solution combined with 0.5mL triamcinolone acetonide injectable solution, USP (40mg per mL)
Sponsors
Sosi Dzhugarian
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who have already been evaluated within at least one of the 4 study clinics with any of the 3 providers who will be administering the treatment * Males or females age 50 and older * Already had completion of imaging of the affected knee(s) via radiography and/or MRI * Imaging demonstrates osteoarthritis of any severity * Diagnosis of primary osteoarthritis of one or both knees * One or more symptoms associated with the osteoarthritis of at least one knee * Patients able to provide informed consent in English and/or Spanish
Exclusion criteria
* Skin infection at or near area of injection site * Recent fracture of the same knee joint within past 6 months * Uncontrolled bleeding disorder * Intra-articular corticosteroid injection within past 3 months * Intra-articular HA injection within the past 3 months * Intra-articular PRP injection within the past 3 months * Presence of prosthetic knee joint in symptomatic knee * Inability to report symptoms due to cognitive impairment * Complete inability to ambulate, even with assistive device * Any person who is pregnant or less than 1 year post-menopause
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario and McMaster Universities Index | From enrollment to 3 months | Scores are on a scale of 0 through 96, with a higher score indicating a worse function level. |
| Pain Visual Analog Scale | From enrollment to 3 months | scale of 0 through 10, with 10 being the highest pain level. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immediate change in pVAS (Pain Visual Analog Scale) | From enrollment to immediately after intervention | pVAS scores from baseline and immediately after injection will be compared. pVAS is on a scale of 0 through 10, with 10 being the highest pain level. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGriffin Elbert, DO
Community Memorial Healthcare
Outcome results
None listed