Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06279507
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2023-10-07
Brief Title:
Efficacy of Hyaluronic Acid Injection in Knee Osteoarthritis
Sponsor:
Phramongkutklao College of Medicine and Hospital
Organization:
Phramongkutklao College of Medicine and Hospital
Study Overview
Official Title:
The Efficacy of Hyaluronic Acid Injection as an Adjunctive Treatment After Intraarticular Low-dose Glucocorticoid Injection for Symptomatic Knee Osteoarthritis A Multicenter Randomized Controlled Double-blinded Study
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None