Effectiveness of ultrasound guided intra-articular injection of platelet rich plasma with ozone in comparison with platelet rich plasma in improving knee function and quality of life in patients with osteoarthritis of the knee: A randomized controlled trial

Knee osteoarthritis is a progressive chronic degenerative musculoskeletal disease of the knee joint which is the commonest rheumatological condition causing pain, functional impairment, chronic disabilities , and diminished quality of life. Diagnosis will be made by the 2016 ACR criteria for early diagnosis of knee osteoarthritis. Non operative treatment includes lifestyle modification, muscle strengthening excercise, physical therapy, NSAIDs, platelet rich plasma(PRP), normal saline, and ozone therapy. Treatment should aim to relieve pain, improve function, limit disabilities, and improve quality of life. PRP is an Otho-biologicals that has anti-inflammatory, immunomodulatory, anti-edemic and anti-oxidative effects whereas ozone has anti-inflammatory, analgesics effects and rapid healing process, both results in improvement in knee function and quality of life with fewer adverse effects. Both have recently gained popularity in the treatment of knee osteoarthritis. Due to confined number of studies available there is enduring need to study the combine effects of platelet rich plasma with ozone therapy. This study is a randomized controlled trial which shall be conducted in the Department of Physical Medicine and Rehabilitation to determine the effectiveness of ultrasound guided intra-articular injection of PRP with ozone in comparison with PRP in the treatment of patients with grade 2 and 3 osteoarthritis of the knee osteoarthritis of the knee. A sample size of 64 patients of grade 2 and 3 osteoarthritis of knee attending PMR OPD, RIMS with knee pain will be chosen and randomized. Outcomes will be measured using SF-36 and WOMAC at baseline, and post-intervention at 1st, 4th, 12th and 24th weeks. For statiscal analysis, the Chi-square test, independent t-test, and repeated measure ANOVA will be used and a p-value<0.05 will be taken as significant.