Effects of Knee Injections on Patients With Knee Osteoarthritis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Therapeutic Effects of Knee Intra-articular Injections on Patients With Knee Osteoarthritis: a Double-blind, Randomized, Placebo-controlled Clinical Trial

Conditions
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Injection, Effect of Drug, Knee Osteoarthritis

Intervention / Treatment
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* Drug: Triamcinolone plus hyruan
* Drug: vitagen plus hyruan
* Drug: normal saline plus hyruan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis of knee osteoarthritis can walk for 15 meters Kellgren-Lawrence grade 2 or greater can follow up for 6 months Exclusion Criteria: 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

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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No

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>triamcinolone plus hyruan injection | Drug: Triamcinolone plus hyruan<br>* triamcinolone plus hyruan injections, one time per week, for 3 weeks<br>* Other names: corticosteroids plus hyaluronic acid;|
| Active Comparator: Experimental<br>vitagen plus hyruan injection | Drug: vitagen plus hyruan<br>* vitagen plus hyruan injections, one time per week, for 3 weeks<br>* Other names: dextrose plus hyaluronic acid;|
| Placebo Comparator: Placebo<br>normal saline plus hyruan injection | Drug: normal saline plus hyruan<br>* normal saline plus hyruan injections, one time per week, for 3 weeks<br>* Other names: normal saline plus hyaluronic acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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steroid, knee osteoarthritis, dextrose, hyaluronic acid