Additional Effects of Triamcinolone to Hyaluronic Acid on Knee Osteoarthritis

Study Overview
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Brief Summary
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Using a double-blind, randomized controlled design to investigate the additional therapeutic effects of 3 times of combined triamcinolone and hyaluronic acid injections to 3 times of hyaluronic acid injections to patients with knee osteoarthritis.

Detailed Description
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A total of 56 patients will be enrolled and randomized into two groups, including 3 times of triamcinolone combined hyaluronic acid injections group and 3 times of hyaluronic acid injections group. The triamcinolone combined hyaluronic acid injections group will receive 3 times of triamcinolone combined hyaluronic acid injection per week in three weeks; the hyaluronic acid group will receive hyaluronic acid injection in three weeks. Physical activities and functional performance will be evaluated at before injection, at after one week, one month, three months, and six months of completion of 3 times of injections.

Official Title
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Additional Therapeutic Effects of Triamcinolone to Hyaluronic Acid on Knee Osteoarthritis: A Double Blind, Randomized-controlled Clinical Trial

Conditions
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Physical Activity, Functional Performance

Intervention / Treatment
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* Drug: Triamcinolone
* Device: Hyaluronic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: knee osteoarthritis with Kellgren/Lawrence grade II or III Exclusion Criteria: who have neurological deficit, such as stroke who have implant in knee

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: triamcinolone and hyaluronic acid group<br>combined triamcinolone (Triamcinolone 10 mg 1cc) and hyaluronic acid (2 cc) injections: one injection per week, for 3 weeks, to compare the additional therapeutic effects of combined triamcinolone and hyaluronic acid injections to hyaluronic acid injections | Drug: Triamcinolone<br>* compare the additional therapeutic effects of triamcinolone combined with hyaluronic acid injections to hyaluronic acid injections only to patients with knee osteoarthritis<br>* Other names: corticosteroids;Device: Hyaluronic acid<br>* compare the additional therapeutic effects of triamcinolone combined with hyaluronic acid injections to hyaluronic acid injections only to patients with knee osteoarthritis<br>|
| Active Comparator: hyaluronic acid group<br>hyaluronic acid (2cc) injection: one injection per week, for 3 weeks, to compare the additional therapeutic effects of combined triamcinolone and hyaluronic acid injections to hyaluronic acid injections | Device: Hyaluronic acid<br>* compare the additional therapeutic effects of triamcinolone combined with hyaluronic acid injections to hyaluronic acid injections only to patients with knee osteoarthritis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional performance assessed with the Western Ontario and McMaster Universities Osteoarthritis Index | Western Ontario and McMaster Universities Osteoarthritis Index | changes from baseline to at after one week, one month, three months, and six months of completion of injections | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10 meter walk test | 10 meter walk as fast as possible | changes from baseline to at after one week, one month, three months, and six months of completion of injections | 
| Quality of life assessed with the Knee Injury and Osteoarthritis Outcome Score | Knee Injury and Osteoarthritis Outcome Score | changes from baseline to at after one week, one month, three months, and six months of completion of injections | 
| 5 times rapid chair rising test | rapid chair rising for 5 times as fast as possible | changes from baseline to at after one week, one month, three months, and six months of completion of injections | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee osteoarthritis, triamcinolone, therapeutic effects