Efficacy of integrated therapy (Yoga and Ayurveda) on clinical outcomes and Quality of life (QOL) among adults with Knee Osteoarthritis: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- After 12 weeks of intervention examine changes in knee osteoarthritis severity symptoms as measured by the change in knee disability score through the WOMAC CRD-PUNE VERSION Scale (The Western Ontario and McMaster Universities Osteoarthritis Index Score for Knee Joint) and KOOS score (Knee Injury and Osteoarthritis Outcome Score).
研究概览
简要总结
Knee Osteoarthritis (OA) is a prevalent degenerative joint disease with a global prevalence of 7.6%. It significantly contributes to the disease burden and medical expenses, impairs physical function, and reduces the quality of life (QOL) in adults.Treatment options include pharmacological, surgical, and non-pharmacological strategies, pharmacological intervention is mostly limited to pain relief whereas surgical interventions are considered an effective treatment option for advanced stages but their effectiveness comes at a significant health expenditure. Non-pharmacological strategies such as Yoga and Ayurveda, which are increasingly recognized as integrative medicine/therapy, are gaining attention due to their holistic and long-term benefits. Knee Osteoarthritis (OA) is a prevalent degenerative joint disease with a global prevalence of 7.6%. It significantly contributes to the disease burden and medical expenses, impairs physical function, and reduces the quality of life (QOL) in adults.Treatment options include pharmacological, surgical, and non-pharmacological strategies, pharmacological intervention is mostly limited to pain relief whereas surgical interventions are considered an effective treatment option for advanced stages but their effectiveness comes at a significant health expenditure. Non-pharmacological strategies such as Yoga and Ayurveda, which are increasingly recognized as integrative medicine/therapy, are gaining attention due to their holistic and long-term benefits.
In this prospective trial, 162 participants aged more than 40 years diagnosed with knee OA following radiographic evidence (Kellgren-Lawrence grade 2 or grade 3) and mild to moderate physical dysfunction score (more than 20 out of 68 measured by WOMAC subscale CRD-Pune version) at baseline will be randomly assigned into two groups either the Yoga + Ayurveda group or the active control group with physiotherapeutic exercise & pharmacological intervention with an allocation ratio of 1:1 and followed for 12 months.
Intervention arm- Yoga+Ayurveda
Tablet of Panchatikta ghrita Guggulu (each 500 mg) 3 times a day after meals
Abhyanga on Knees with Panchaguna Taila (20 ml) for 15 min twice a day
Alongside a structured 45-min validated Yoga regimen via an online platform five days/week for 12 weeks.
Comparator arm- Active Control arm
•Physiotherapeutic exercise tailored for OA among adults will be provided which will include hot fomentation twice daily
•The use topical NSAIDs (Diclofenac gel) after fomentation or whenever pain arises.
Data will be collected at the end of the 12th week of therapy, and follow-up data will be collected at 6 and 12 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals aged more than 40 years,
- •Capacity to understand and follow yoga practice instructions.
- •Radiographic evidence of knee osteoarthritis Kellgren-Lawrence grade 2 or grade 3 on radiographs.
- •Persistent pain / Constant discomfort for 3 months before recruitment
- •Mild to moderate physical dysfunction (score more than 15 out of 68 on the physical function knee subscale of the Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC CRD- Pune version]).
排除标准
- •Inability to participate in physical activity due to severe hearing or visual impairment, physical handicaps, fear of falling or balance issues, heart failure grade 4
- •Known cases of having active psychological illnesses
- •Above stage 3 renal disease.
- •Prolonged use of a knee brace, cane, walker, or wheelchair which may suggest instability.
- •Received corticosteroid and hyaluronic acid injections in the affected joint within three months of study admission.
- •Have had knee surgery/ knee arthroscopy or had a joint replacement before.
- •BMI more than 30
- •Knee pain caused by congenital dysplasia, rheumatoid arthritis, autoimmune diseases, and malignancies.
结局指标
主要结局
After 12 weeks of intervention examine changes in knee osteoarthritis severity symptoms as measured by the change in knee disability score through the WOMAC CRD-PUNE VERSION Scale (The Western Ontario and McMaster Universities Osteoarthritis Index Score for Knee Joint) and KOOS score (Knee Injury and Osteoarthritis Outcome Score).
时间窗: 0, 12 weeks; 6 and 12 months
次要结局
- Reduction in pain & difficulty performing daily activities after 12 weeks of treatment assessed using the WOMAC CRD PUNE VERSION subscale (physical function, pain)
- Change in psychological parameters (depression, anxiety, stress) through DASS score.
- Change in quality of life after twelve weeks of integrated Ayurveda & yoga therapy through SF-36.(0, 12 weeks, 6 & 12 months)
研究者
Yashwant Mishra
All India Institute Of Medical Science Rishikesh