A Phase 4 interventional study of Sodium Hyaluronate and Normal Saline in Knee Osteoarthritis, Pain, Joint and Stiffness of Knee, Not Elsewhere Classified, sponsored by Phramongkutklao College of Medicine and Hospital. Recruiting at 1 site in Thailand. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-02-28.
Sponsored by Phramongkutklao College of Medicine and Hospital · Phase 4, Interventional, and Treatment
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's planned enrollment of 176 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Phramongkutklao College of Medicine and Hospital is the lead sponsor of 36 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria: Participants who have
Hyaluronic acid, Ostenil Plus, 2 mL (40 mg) will be injected once afer 2-4 week of glucocorticoid injection
Drug: Sodium Hyaluronate · Drug: Triamcinolone Acetonide 10mg/mL
Two-millilitres of normal saline will be injected once after 2-4 weeks of glucocorticoid injection
Drug: Normal Saline · Drug: Triamcinolone Acetonide 10mg/mL
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
Also known as: Ostenil Plus
0.9% sodium chloride 2 mL prepared in plastic syringe
Also known as: 0.9% sodium chloride
10 mg of triamcinolone acetonide will be injected to all participants before the specified intervention
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)
Time frame: 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)
Time frame: 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)
Time frame: 12 and 24 weeks after injection
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
Time frame: 12 and 24 weeks after injection
Quality of life assessment
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)
Time frame: 12 and 24 weeks after injection
Plan to share: No
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Phramongkutklao College of Medicine and Hospital