Comparing the efficacy and safety of Sri Lankan traditional medicine regimen for knee osteoarthritis

Not Applicable

• Conditions: Knee osteoarthritis; Musculoskeletal Diseases; Osteoarthritis of knee

• Registration Number: ISRCTN58050062
• Lead Sponsor: niversity of Colombo

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36415006/ (added 28/11/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-03
• Last Update Posted: 12 December 2023
• Study Completion: 2024-08-11

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 140

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 <30 min
1.1.3. Crepitus on knee motion
1.1.4. Bony tenderness
1.1.5. Bony enlargement
1.1.6. No palpable warmth
1.2. ACR Clinical/Radiographic classification criteria, where KOA is classified by the presence of knee pain with at least one of the following three items along with osteophyte in knee X-Ray:
1.2.1. Aged >50 years
1.2.2. Morning stiffness <30 min
1.2.3. Crepitus on knee motion
1.3. ACR Clinical/Laboratory classification criteria, where KOA is classified by the presence of knee pain along with at least 5 of the following 9 items:
1.3.1. Aged >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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measure as of 04/08/2022:<br><br> 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).<br><br> _____<br><br> Previous primary outcome measure:<br><br> 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<br>