Clinical trial NCT06279507: Efficacy of Hyaluronic Acid Injection in Knee Osteoarthritis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Knee Osteoarthritis
Pain, Joint
Stiffness of Knee, Not Elsewhere Classified
Quality of Life
Keywords: Hyaluronic acid
Adjunctive treatment
Lead sponsor: Phramongkutklao College of Medicine and Hospital
Sponsor class: OTHER
Collaborators: name: Chulalongkorn University
name: Khon Kaen University
name: Police General Hospital
First posted: 2024-02-28
Enrollment: 176
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants would be allocated into one treatment group;

* Intervention group : Hyaluronic acid injection
* Placebo group : Normal saline
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria: 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

Primary outcomes:
measure: Pain outcome measurement
timeFrame: 12 and 24 weeks after injection
measure: Joint stiffness and function measurement
timeFrame: 12 and 24 weeks after injection
measure: Overall symptom assessment
timeFrame: 12 and 24 weeks after injection
Secondary outcomes:
measure: Knee performance evaluation
timeFrame: 12 and 24 weeks after injection
measure: Quality of life assessment
timeFrame: 12 and 24 weeks after injection
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
Study officials:
affiliation: Phramongkutklao College of Medicine and Hospital
name: Nis Okuma, Medical
role: PRINCIPAL_INVESTIGATOR
References: