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| Name | Class |
|---|---|
| Chulalongkorn University | OTHER |
| Khon Kaen University | OTHER |
| Police General Hospital | OTHER |
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The aim of this clinical trial study is to compare the efficacy of Hyaluronic injection in patients with symptomatic knee osteoarthritis. The main questions it aims to answer are:
Participants will be allocated to receive one treatments; either Hyaluronic acid or normal saline injections after receiving glucocorticoid injection.
Researchers will compare the Hyaluronic acid with normal saline injection to see if the former show superior effect in terms of pain, joint stiffness, function, as well as health-related quality of life comparing with placebo.
Participants who had been diagnosed with knee osteoarthritis according to American College of Rheumatology (ACR) criteria will be enrolled in this study. After the participants receive the information and consent to participate in this study, they will be examined their affected knee by the co-researchers. Ten-milligrams of Triamcinolone will be injected intra-articular into knee joint.
Two-to-four weeks later, the participants will be evaluated for knee pain, stiffness, function and quality of life, as well as knee performance status. Participants whose their knee joint absence of effusion will be allocated in to one treatment group; either Hyaluronic acid or normal saline. After injection, participants will be scheduled for the follow-up visit in 12 and 24 weeks later. In each follow-up visit, they will be evaluated for joint pain, stiffness, function and quality of life, as well as analgesic use and adverse reaction form treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyaluronic acid | Active Comparator | Hyaluronic acid, Ostenil Plus, 2 mL (40 mg) will be injected once afer 2-4 week of glucocorticoid injection |
|
| Normal saline | Placebo Comparator | Two-millilitres of normal saline will be injected once after 2-4 weeks of glucocorticoid injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Hyaluronate | Drug | Sodium hyaluronate 2% (40 mg/2 mL), with molecular weight of 1-2 million dalton Other active ingredient : Mannitol 0.5% Preparation : Pre-filled syringe |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain outcome measurement | The comparison between Hyaluronic acid and normal saline injection in the change of joint pain after the injection, by using visual analog scale and pain domain assessment in Western Ontario and McMaster University (WOMAC) scale (scale 0-10, which higher scale reflects worse symptom) | 12 and 24 weeks after injection |
| Joint stiffness and function measurement | The comparison between Hyaluronic acid and normal saline injection in the change of joint stiffness and function after the injection, by using WOMAC scale (scale 0-10, which higher scale reflects worse symptom or function) | 12 and 24 weeks after injection |
| Overall symptom assessment | The comparison between Hyaluronic acid and normal saline injection in the change of overall symptom after the injection, by using patient's global assessment (scale 0-10, which higher scale reflects worse condition) | 12 and 24 weeks after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Knee performance evaluation | The comparison between Hyaluronic acid and normal saline injection in the change of knee performance status after the injection, assessed by Time Up and Go test | 12 and 24 weeks after injection |
| Quality of life assessment |
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Inclusion Criteria:
Exclusion Criteria: Participants who have
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nis Okuma, Medical | Contact | 669-24759900 | nitzumo@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Nis Okuma, Medical | Phramongkutklao College of Medicine and Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phramongkutklao Hospital | Recruiting | Bangkok | 10400 | Thailand |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000077324 | Crystalloid Solutions |
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The participants would be allocated into one treatment group;
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Participants will not know what treatment they receive. Co-investigators will not know what the participants are injected. Outcome assessor will not know which treatment participant receive.
|
| Normal Saline | Drug | 0.9% sodium chloride 2 mL prepared in plastic syringe |
|
|
| Triamcinolone Acetonide 10mg/mL | Drug | 10 mg of triamcinolone acetonide will be injected to all participants before the specified intervention |
|
The comparison between Hyaluronic acid and normal saline injection in the change of health-related quality of life assessed by EuroQol group - 5 Dimensions - 5 Levels (EQ-5D-5L) tool (scale 0-100, which higher scale reflects better health)
| 12 and 24 weeks after injection |
| D012216 |
| Rheumatic Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007552 |
| Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |