Knee osteoarthritis Musculoskeletal Diseases Osteoarthritis of knee
Conditions
Interventions
This will be a two-arm open-label non-inferiority randomized control trial in patients with knee osteoarthritis. A consecutive consenting sample method will be followed to select participants of the a
Sponsors
University of Colombo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosis and classification of knee osteoarthritis (KOA) based on history, clinical examination findings, and classical radiological findings as follows: 1. The three American College of Rheumatology (ACR) classification criteria for the knee shown below, but for this study the lower age limit will be reduced from 50 years to 40 years: 1.1. ACR Clinical classification criteria, where KOA is classified by the presence of knee pain along with at least three of the following six items: 1.1.1. Aged >50 years 1.1.2. Morning stiffness 50 years 1.2.2. Morning stiffness 50 years 1.3.2. Morning stiffness <30 min 1.3.3. Crepitus on knee motion 1.3.4. Bony tenderness 1.3.5. Bony enlargement 1.3.6. No palpable warmth 1.3.7. Rheumatoid Factor <1:40 1.3.8. Erythrocyte sedimentation rate (ESR) <40 mm/h 1.3.9. Synovial fluid compatible with OA 2. Visual Analogue Score (VAS) for pain mean pain intensity in one or both knees of =40 mm on a 100 mm while performing a weight-bearing activity (walking, standing, or climbing a staircase) over the 7 days before baseline assessment. The VAS used will be a five-point Likert scale version with five response levels for each item, representing different degrees of intensity: None (0), mild (1), moderate (2), severe (3), and extreme (4). 3. Radiographic evidence of OA grades 1-3 assessed using the ranking score of the Kellgren-Lawrence radiographic system (0-4)
Exclusion criteria
Exclusion criteria: 1. Non-degenerative joint diseases or other joint diseases such as rheumatoid arthritis, psoriatic arthritis, gonococcal arthritis, and haemoarthritis 2. Severe disabling arthritis and/or are bedridden 3. History of intra-articular knee injection within the month preceding the study 4. Evidence of severe unstable cancer, hypertension, cardiac disorder, mental health disorder, or renal, hepatic, diabetic, or haemopoietic disease revealed by history and/or investigation 5. Concurrent anticoagulant/antiplatelet drugs, corticosteroids, or narcotic pain killers use 6. History of epilepsy or bleeding disorders, gastric ulcers, renal or hepatic disease, uncontrolled hypertension, or body mass index (BMI) >45 kg/m² 7. A washout period of 7 days is required for NSAID users 8. Discontinuing the use of common complementary and alternative therapies for arthritis (e.g. glucosamine, chondroitin sulfate, bromelain, DMSO, acupuncture, and Ayurveda medicine) is required for 7 days prior to enrollment 9. Written informed consent to participate in the study not provided
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 04/08/2022: The primary endpoint is a percentage change in the score on the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) measured at the baseline and the end of the intervention (after 8 weeks). _____ Previous primary outcome measure: Knee symptoms and function measured using the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) and the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline, 12 weeks, and 4 and 5 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 04/08/2022: Change in Knee Injury and Osteoarthritis Outcome Score (KOOS), a pain disability index, a visual analog scale for pain and sleep quality, a quality-of-life index (The World Health Organization (WHO) , The WHOQOF : https://www.who.int/tools/whoqol) measured at the baseline and the end of the intervention (after 8 weeks and 1 month, 2month and 3 month of follow-up). _____ Previous secondary outcome measures: 1. Knee pain, function, and stiffness measured using WOMAC subscales at baseline, 12 weeks, and 4 and 5 months 2. Impact of knee pain measured using the pain disability index at baseline, 12 weeks, and 4 and 5 months 3. Pain measured using a visual analog scale (VAS) at baseline, 12 weeks, and 4 and 5 months 4. Sleep quality measured using a visual analog scale (VAS) at baseline, 12 weeks, and 4 and 5 months 5. Quality of life measured using the quality-of-life index at baseline, 12 weeks, and 4 and 5 months | — |
Countries
Sri Lanka
Contacts
Public ContactPathirage Kamal Perera
Outcome results
None listed