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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
triamcinolone plus hyruan injections, one time per week, for 3 weeks
vitagen plus hyruan injections, one time per week, for 3 weeks
normal saline plus hyruan injections, one time per week, for 3 weeks
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan
Western Ontario and McMaster Universities Osteoarthritis index
assess knee related performance, scores: 0-100, higher score indicates a worse outcome
Time frame: changes of scores from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections
physical functional performance-walking
10 meters normal and fast walking speed
Time frame: changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections
physical functional performance-stairs climbing
time for up and down stairs
Time frame: changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections
physical functional performance-chair rising
time for 5 repeated chair-rising time
Time frame: changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections
physical functional performance-balance
time for up and go test
Time frame: changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections
Knee Injury and Osteoarthritis Outcome Score
assess knee osteoarthritis related function, scores: 0-100, higher score indicates a better outcome
Time frame: changes of scores from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections
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