Efficacy of Hyaluronic Acid Injection in Knee Osteoarthritis

February 25, 2024 updated by: Phramongkutklao College of Medicine and Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

176

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Recruiting
        • Phramongkutklao Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hyaluronic acid
Hyaluronic acid, Ostenil Plus, 2 mL (40 mg) will be injected once afer 2-4 week of glucocorticoid injection
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
Other Names:
  • Ostenil Plus
Drug: Triamcinolone Acetonide 10mg/mL
10 mg of triamcinolone acetonide will be injected to all participants before the specified intervention
Placebo Comparator: Normal saline
Two-millilitres of normal saline will be injected once after 2-4 weeks of glucocorticoid injection
Drug: Triamcinolone Acetonide 10mg/mL
10 mg of triamcinolone acetonide will be injected to all participants before the specified intervention
Drug: Normal Saline
0.9% sodium chloride 2 mL prepared in plastic syringe
Other Names:
  • 0.9% sodium chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain outcome measurement
Time Frame: 12 and 24 weeks after injection
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)
12 and 24 weeks after injection
Joint stiffness and function measurement
Time Frame: 12 and 24 weeks after injection
The comparison between Hyaluronic acid and normal saline injection in the change of joint stiffness and function after the injection, by using WOMAC scale (scale 0-10, which higher scale reflects worse symptom or function)
12 and 24 weeks after injection
Overall symptom assessment
Time Frame: 12 and 24 weeks after injection
The comparison between Hyaluronic acid and normal saline injection in the change of overall symptom after the injection, by using patient's global assessment (scale 0-10, which higher scale reflects worse condition)
12 and 24 weeks after injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee performance evaluation
Time Frame: 12 and 24 weeks after injection
The comparison between Hyaluronic acid and normal saline injection in the change of knee performance status after the injection, assessed by Time Up and Go test
12 and 24 weeks after injection
Quality of life assessment
Time Frame: 12 and 24 weeks after injection
The comparison between Hyaluronic acid and normal saline injection in the change of health-related quality of life assessed by EuroQol group - 5 Dimensions - 5 Levels (EQ-5D-5L) tool (scale 0-100, which higher scale reflects better health)
12 and 24 weeks after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phramongkutklao College of Medicine and Hospital

Collaborators

Chulalongkorn University
Khon Kaen University
Police General Hospital

Investigators

  • Principal Investigator: Nis Okuma, Medical, Phramongkutklao College of Medicine and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2024

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

October 7, 2023

First Submitted That Met QC Criteria

February 25, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 25, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMK-00007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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