Evaluation of the efficacy of Ashwagandha in chronic knee pain among older adults with knee osteoarthritis A Protocol of a double-blind randomized controlled trial

Background: Chronic knee pain, primarily due to knee osteoarthritis, significantly impairs quality of life of the elderly by restricting mobility, reducing physical activity, and contributing to psychological distress such as depression and anxiety. The standard of care include pharmacological treatments (e.g., NSAIDs, analgesics), physical therapy, lifestyle modifications, and, in severe cases, surgical interventions, most of which often do not provide sustained relief, may carry adverse effects, and lead to poly-pharmacy, particularly in elderly patients with comorbidities. Ashwagandha is known to have Balya (strengthening) and Rasayana (adaptogenic/ rejuvenating) properties, pacifies Vata and thus may be helpful in mitigating chronic musculoskeletal pain. Objective: To evaluate the efficacy of oral Ashwagandha & Til Taila Abhyanga for six weeks on chronic knee pain, functionality, mobility, quality of life, general wellbeing, sleep quality of the older adults with knee osteoarthritis. Materials & Methods: Patients of any gender, above 60 years age and having pain in one or both knee joints since more than 3 months and average severity rated [≥]4 on the Wong-Baker Faces, due to knee osteoarthritis diagnosed as per the American College of Rheumatology Criteria are being included in the study. Medically unstable and non-ambulatory patients with severity Grade>4 of Kellgren and Lawrence scale for OA, BMI[≥]30 kg/m2, those on recent treatment with intra-articular injections or Ayurveda medications, having knee implant or fixed flexion deformity in knees, history of acute trauma, or with severe systemic/infectious ailments or other chronic conditions affecting the knee joint are excluded. Total 72 participants are enrolled and allocated randomly to either group. Participants are given either Ahwagandha Churna or Boswellia extract as oral medication for 45 days. Til Taila and standard operating procedure of Abhyanga (external oleation through massage) at the affected knee are given in both groups. The severity of pain is assessed by the numeric pain rating scale after every 15 days. Other outcomes are change in Knee Injury and Osteoarthritis Outcome Score, score of WHO Wellbeing Index -5, Global Sleep Assessment Questionnaire, Five Times Sit and Stand test and Time to Up and Go, after the intervention period. The need for conventional analgesics through the study duration is also observed and will be compared in both groups. Discussion: The outcomes of this double-blind randomized controlled trial will inform about the efficacy of Ashwagandha which is generally considered as Balya in alleviating chronic pain of knee osteoarthritis among elderly. This study can generate evidence and lead to larger effectiveness studies on role of adding Ashwagandha to the standard care for management of chronic musculoskeletal pain in older adults.