Effects of Knee Injections on Patients With Knee Osteoarthritis
- Conditions
- InjectionEffect of DrugKnee Osteoarthritis
- Interventions
- Registration Number
- NCT05220527
- Lead Sponsor
- Taipei Medical University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- clinical diagnosis of knee osteoarthritis
- can walk for 15 meters
- Kellgren-Lawrence grade 2 or greater
- can follow up for 6 months
- Major diseases will affect balance, such as stroke
- infectious disease,
- rheumatoid arthritis,
- malignancy
- pregnancy or prepare to pregnant
- received knee injections in the past 6 months
- previous knee operation history
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental vitagen plus hyruan vitagen plus hyruan injection Study group Triamcinolone plus hyruan triamcinolone plus hyruan injection Placebo normal saline plus hyruan normal saline plus hyruan injection
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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-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
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
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
Trial Locations
- Locations (1)
Shin Kong Wu Ho-Su Memorial Hospital
🇨🇳Taipei, Taiwan