Efficacy of Hyaluronic Acid Injection in Knee Osteoarthritis

Phase 4RecruitingNCT06279507

Phramongkutklao College of Medicine and Hospital176 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Interventions

Sodium HyaluronateDRUG

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

Normal SalineDRUG

0.9% sodium chloride 2 mL prepared in plastic syringe

Triamcinolone Acetonide 10mg/mLDRUG

10 mg of triamcinolone acetonide will be injected to all participants before the specified intervention

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)