Efficacy of Hyaluronic Acid Injection in Knee Osteoarthritis
- Conditions
- Pain, JointStiffness of Knee, Not Elsewhere ClassifiedQuality of LifeKnee Osteoarthritis
- Interventions
- Registration Number
- NCT06279507
- Lead Sponsor
- Phramongkutklao College of Medicine and Hospital
- Brief Summary
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:
* 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 176
- All participants who had been diagnosed as knee osteoarthritis according to ACR criteria with symptom of knee pain
- Pain visual analog scare of 4 or higher
Participants who have
- Cognitive impairment
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hyaluronic acid Triamcinolone Acetonide 10mg/mL Hyaluronic acid, Ostenil Plus, 2 mL (40 mg) will be injected once afer 2-4 week of glucocorticoid injection Normal saline Normal Saline Two-millilitres of normal saline will be injected once after 2-4 weeks of glucocorticoid injection Normal saline Triamcinolone Acetonide 10mg/mL Two-millilitres of normal saline will be injected once after 2-4 weeks of glucocorticoid injection Hyaluronic acid Sodium Hyaluronate Hyaluronic acid, Ostenil Plus, 2 mL (40 mg) will be injected once afer 2-4 week of glucocorticoid injection
- Primary Outcome Measures
Name Time Method Joint stiffness and function measurement 12 and 24 weeks after injection 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)
Pain outcome measurement 12 and 24 weeks after injection 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)
Overall symptom assessment 12 and 24 weeks after injection 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)
- Secondary Outcome Measures
Name Time Method Quality of life assessment 12 and 24 weeks after injection 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)
Knee performance evaluation 12 and 24 weeks after injection 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
Trial Locations
- Locations (1)
Phramongkutklao Hospital
🇹ðŸ‡Bangkok, Thailand