Effect of Drug, Injection, Knee Osteoarthritis
Conditions
Keywords
knee osteoarthritis, steroid, hyaluronic acid, dextrose
Brief summary
Using a double-blind, randomized, placebo-controlled design to compare the immediate, short-term, and intermediate-term additional therapeutic effects of ultrasound-guided corticosteroid injection and dextrose injection to hyaluronic acid injection on patients with knee osteoarthritis, under the basis of International Classification of Functioning, Disability and Health.
Detailed description
A total of 60 patients will be collected. The participants will be randomized into three groups, including the hyaluronic acid combined corticosteroid group, hyaluronic acid combined dextrose group, and hyaluronic acid combined normal saline group (placebo group). The functional performance and knee-related quality of life (Western Ontario and McMaster Universities Osteoarthritis index、Knee Injury and Osteoarthritis Outcome Score), pain (pressure threshold by pain pressure ergometer), and physical activity (10 meters normal and fast walk, up and downstairs, 5 repeated chair-rising time, timed up and go test) and image progression by high-resolution ultrasound will be evaluated before treatment, one week after injections, one month after injections, three months after injections, and six months after injections. Participants and evaluators will be both blinded to the group's allocation during the whole course of intervention.
Interventions
DRUGTriamcinolone plus hyruan
triamcinolone plus hyruan injections, one time per week, for 3 weeks
DRUGvitagen plus hyruan
vitagen plus hyruan injections, one time per week, for 3 weeks
DRUGnormal saline plus hyruan
normal saline plus hyruan injections, one time per week, for 3 weeks
Sponsors
Shin Kong Wu Ho-Su Memorial Hospital
Taipei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. clinical diagnosis of knee osteoarthritis 2. can walk for 15 meters 3. Kellgren-Lawrence grade 2 or greater 4. can follow up for 6 months
Exclusion criteria
1. Major diseases will affect balance, such as stroke 2. infectious disease, 3. rheumatoid arthritis, 4. malignancy 5. pregnancy or prepare to pregnant 6. received knee injections in the past 6 months 7. previous knee operation history
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario and McMaster Universities Osteoarthritis index | changes of scores from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections | assess knee related performance, scores: 0-100, higher score indicates a worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| physical functional performance-walking | changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections | 10 meters normal and fast walking speed |
| physical functional performance-stairs climbing | changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections | time for up and down stairs |
| physical functional performance-chair rising | changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections | time for 5 repeated chair-rising time |
| physical functional performance-balance | changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections | time for up and go test |
| Knee Injury and Osteoarthritis Outcome Score | changes of scores from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections | assess knee osteoarthritis related function, scores: 0-100, higher score indicates a better outcome |
Countries
Taiwan
Outcome results
None listed