Clinical trial

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

Name

PMK-00007

Description

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.

Trial arms

Trial start

2024-02-10

Estimated PCD

2025-01-31

Trial end

2025-06-30

Status

Recruiting

Phase

Early phase I

Treatment

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

Arms:

Hyaluronic acid

Other names:

Ostenil Plus

Normal Saline

0.9% sodium chloride 2 mL prepared in plastic syringe

Arms:

Normal saline

Other names:

0.9% sodium chloride

Triamcinolone Acetonide 10mg/mL

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

Arms:

Hyaluronic acid, Normal saline

Size

176

Primary endpoint

Pain outcome measurement

12 and 24 weeks after injection

Joint stiffness and function measurement

12 and 24 weeks after injection

Overall symptom assessment

12 and 24 weeks after injection

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The participants would be allocated into one treatment group;\n\n* Intervention group : Hyaluronic acid injection\n* Placebo group : Normal saline', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Participants will not know what treatment they receive. Co-investigators will not know what the participants are injected. Outcome assessor will not know which treatment participant receive.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 176, 'type': 'ESTIMATED'}}

Updated at

2024-02-28

1 organization

2 products

1 drug

6 indications

Organization

Phramongkutklao College of Medicine and Hospital

Product

Sodium Hyaluronate

Indication

Osteoarthritis, Knee