Efficacy of Hyaluronic Acid Injection in Knee Osteoarthritis
NCT ID: NCT06279507
Last Updated: 2024-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
176 participants
INTERVENTIONAL
2024-02-10
2025-06-30
Brief Summary
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* Is Hyaluronic acid injection improve pain symptom, joint stiffness, and joint function in patients with knee osteoarthritis
* Is Hyaluronic acid injection improve knee performance status and health-related quality of life in patients with knee osteoarthritis
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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* Intervention group : Hyaluronic acid injection
* Placebo group : Normal saline
TREATMENT
QUADRUPLE
Study Groups
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Hyaluronic acid
Hyaluronic acid, Ostenil Plus, 2 mL (40 mg) will be injected once afer 2-4 week of glucocorticoid injection
Sodium Hyaluronate
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
Triamcinolone Acetonide 10mg/mL
10 mg of triamcinolone acetonide will be injected to all participants before the specified intervention
Normal saline
Two-millilitres of normal saline will be injected once after 2-4 weeks of glucocorticoid injection
Normal Saline
0.9% sodium chloride 2 mL prepared in plastic syringe
Triamcinolone Acetonide 10mg/mL
10 mg of triamcinolone acetonide will be injected to all participants before the specified intervention
Interventions
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Sodium Hyaluronate
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
Normal Saline
0.9% sodium chloride 2 mL prepared in plastic syringe
Triamcinolone Acetonide 10mg/mL
10 mg of triamcinolone acetonide will be injected to all participants before the specified intervention
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pain visual analog scare of 4 or higher
Exclusion Criteria
* History of aller to Hyaluronic acid or its component
* History of knee arthropathy
* Concomitant with inflammatory arthritis
* Serious comorbidities or bedridden status
* Current pregnancy or lactation
* Currently use of symptomatic slow acting drugs for osteoarthritis (SYSADOA)
* Communication problem
50 Years
ALL
No
Sponsors
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Chulalongkorn University
OTHER
Khon Kaen University
OTHER
Police General Hospital
OTHER
Phramongkutklao College of Medicine and Hospital
OTHER
Responsible Party
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Principal Investigators
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Nis Okuma, Medical
Role: PRINCIPAL_INVESTIGATOR
Phramongkutklao College of Medicine and Hospital
Locations
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Phramongkutklao Hospital
Bangkok, , Thailand
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PMK-00007
Identifier Type: -
Identifier Source: org_study_id
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