Efficacy of Hyaluronic Acid Injection in Knee Osteoarthritis

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06279507
• Other study ID #: PMK-00007
• Status: Recruiting
• Phase: Phase 4
• Start date: February 10, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: Phramongkutklao College of Medicine and Hospital
• Contact: Nis Okuma, Medical
• Phone: 669-24759900
• Email: nitzumo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 176
• Est. completion date: June 30, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Thailand	Phramongkutklao Hospital	Bangkok

Sponsors (4)

Lead Sponsor	Collaborator
Phramongkutklao College of Medicine and Hospital	Chulalongkorn University, Khon Kaen University, Police General Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	12 and 24 weeks after injection
Primary	Joint stiffness and function measurement	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
Primary	Overall symptom assessment	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	Knee performance evaluation	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
Secondary	Quality of life assessment	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