Efficacy of Hyaluronic Acid Injection in Knee Osteoarthritis

Last updated: February 25, 2024
Sponsor: Phramongkutklao College of Medicine and Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Muscle Pain

Arthritis And Arthritic Pain

Osteoarthritis

Treatment

Normal Saline

Sodium Hyaluronate

Triamcinolone Acetonide 10mg/mL

Clinical Study ID

NCT06279507
PMK-00007
  • Ages > 50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All participants who had been diagnosed as knee osteoarthritis according to ACRcriteria with symptom of knee pain
  • Pain visual analog scare of 4 or higher

Exclusion

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

Study Design

Total Participants: 176
Treatment Group(s): 3
Primary Treatment: Normal Saline
Phase: 4
Study Start date:
February 10, 2024
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • Phramongkutklao Hospital

    Bangkok, 10400
    Thailand

    Active - Recruiting

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