Knee Osteoarthritis, Pain, Joint, Stiffness of Knee, Not Elsewhere Classified, Quality of Life
Conditions
Keywords
Hyaluronic acid, Adjunctive treatment
Brief 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.
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.
Interventions
DRUGSodium 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
DRUGNormal Saline
0.9% sodium chloride 2 mL prepared in plastic syringe
10 mg of triamcinolone acetonide will be injected to all participants before the specified intervention
Sponsors
Chulalongkorn University
Khon Kaen University
Police General Hospital
Phramongkutklao College of Medicine and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
The participants would be allocated into one treatment group; * Intervention group : Hyaluronic acid injection * Placebo group : Normal saline
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain outcome measurement | 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) |
| Joint stiffness and function measurement | 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) |
| Overall symptom assessment | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee performance evaluation | 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 |
| Quality of life assessment | 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) |
Countries
Thailand
Contacts
Primary ContactNis Okuma, Medical
Outcome results
None listed