NCT06279507

Efficacy of Hyaluronic Acid Injection in Knee Osteoarthritis

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: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 176 (estimated)
• Sponsor: Phramongkutklao College of Medicine and Hospital · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Knee Osteoarthritis
• Pain, Joint
• Stiffness of Knee, Not Elsewhere Classified
• Quality of Life

Interventions

Type	Name	Description
DRUG	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
DRUG	Normal Saline	0.9% sodium chloride 2 mL prepared in plastic syringe
DRUG	Triamcinolone Acetonide 10mg/mL	10 mg of triamcinolone acetonide will be injected to all participants before the specified intervention

Timeline

• Start date: 2024-02-10
• Primary completion: 2025-01-31
• Completion: 2025-06-30
• First posted: 2024-02-28
• Last updated: 2024-02-28

Locations

1 site across 1 country: Thailand