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| Name | Class |
|---|---|
| Shin Kong Wu Ho-Su Memorial Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | triamcinolone plus hyruan injection |
|
| Experimental | Active Comparator | vitagen plus hyruan injection |
|
| Placebo | Placebo Comparator | normal saline plus hyruan injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triamcinolone plus hyruan | Drug | triamcinolone plus hyruan injections, one time per week, for 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario and McMaster Universities Osteoarthritis index | assess knee related performance, scores: 0-100, higher score indicates a worse outcome | changes of scores from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections |
| Measure | Description | Time Frame |
|---|---|---|
| physical functional performance-walking | 10 meters normal and fast walking speed | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ru-Lan Hsieh, MD | Shin Kong Wu Ho-Su Memorial Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shin Kong Wu Ho-Su Memorial Hospital | Taipei | 111-01 | Taiwan |
By request, the data will be shared with other researchers.
The data will become available after publication and for one year since publication.
Request by mail to the investigator.
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D000305 | Adrenal Cortex Hormones |
| D006820 | Hyaluronic Acid |
| D005947 | Glucose |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| vitagen plus hyruan | Drug | vitagen plus hyruan injections, one time per week, for 3 weeks |
|
|
| normal saline plus hyruan | Drug | normal saline plus hyruan injections, one time per week, for 3 weeks |
|
|
time for up and down stairs
| 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 | 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 | 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 | changes of scores from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections |
| D012216 |
| Rheumatic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |