Y-PRP Trial : Yoga enhanced PRP vs Conventional PRP- Growth factor assessment and functional outcomes in early knee osteoarthritis
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- CCRYN
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To study the effect of specific yoga protocol on the cell count & growth factor yield of PRP
研究概览
简要总结
Patients presenting with symptoms of knee pain, crepitus, and/or stiffness will be assessed and recruited in the Orthopaedics OPD in PGIMER. A detailed history, general health check-up and a clinical examination of the knee will be performed for each subject to make a differential diagnosis. This examination will include a general physical examination, knee examination, and x-ray of both knees to confirm the diagnosis of OA. The x-rays will be taken in two orthogonal views: a standing anteroposterior and a 30-60° accurate lateral view, through a digital radiographic machine and print on a standard x-ray film will be taken for analysis and grading of OA. Patients with symptomatic KL grade 1 or 2 knee OA fulfilling the inclusion criteria will be recruited for the study after taking written informed consent. All patients will be assessed for pain, stiffness, and functional status using a validated score for knee OA i.e. Western Ontario and McMaster Universities Arthritis Index Questionnaire (WOMAC) score29. Pain in the affected knee joint will be assessed using the Visual Analog Scale(VAS)30. Psychological Scoring will also be done using DASS 2131 Scale to rule out any distress or anxiety-related factors which may affect patient satisfaction after the injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Symptomatic Primary OA Knee OA classified as Grade 1 & 2 who have responded to conservative treatment for 6 months.
排除标准
- •Secondary OA Grade 3& 4 OA immunocompromised status or uncontrolled diabetes bronchial Asthma or known cardiac disease Symptomatic OA affecting joint other than knees Recent 6 month intra articular steroids anti coagulation therapy active or previous infections unwilling to follow exercise protocol/ not consenting for intervention.
结局指标
主要结局
To study the effect of specific yoga protocol on the cell count & growth factor yield of PRP
时间窗: Check whether PRP has better Growth Factor post yoga therapy
次要结局
- To compare functional outcomes in terms of WOMAC, VAS, DASS 21 score between conventional & yoga enhanced PRP(At 6 weeks, 3 months & 6 months)
