To Evaluate efficacy of Integrated Yoga Therapy versus Physiotherapy for Chronic Low Back Pain in elderly adults- A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of Integrated Yoga Therapy versus Physiotherapy in reducing intensity of pain in elderly patients with Chronic Low Back Pain using the 11-point Numerical Rating Scale (NRS).
研究概览
简要总结
The study is aimed at evaluating the efficacy of Integrated Yoga Therapy vs Physiotherapy as management option for chronic low back pain in elderly patients. Patients will be provided with 2 weeks of monitored therapy followed by 10 weeks of home based follow up. Patients will be evaluated for pain using the 11 point Numerical Rating Scale at baseline, 1 month, 2 month and 3 month. They will also be assessed for feasibility , improvement in spinal flexibility, improvement id back disability, body mass composition and serum IGF-1 levels at baseline, 1 month and 3rd month. The patients in both the groups will be advised to continue their pharmacological therapy they are receiving which will be reviewed and modified during follow up according to the need of the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 60.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with chronic low back pain for more than three months of moderate intensity 2.Age between 60-80 years 3.ASA grade 1-3 patients.
排除标准
- •1.Patients practicing yoga more than 4 times per month 2.Patients undergoing physiotherapy for back pain in previous 3 months 3.Chronic low back pain due to uncommon causes such as congenital, infective, inflammatory, traumatic, neoplasm and metabolic conditions 4.Referred low back pain due to gynaecological diseases, genitourinary problems, or gastrointestinal conditions.
结局指标
主要结局
To evaluate the efficacy of Integrated Yoga Therapy versus Physiotherapy in reducing intensity of pain in elderly patients with Chronic Low Back Pain using the 11-point Numerical Rating Scale (NRS).
时间窗: 1 month. 2 month, 3 months
次要结局
- To compare Integrated Yoga Therapy with Physiotherapy for(1)Feasibility and safety of therapy in elderly population)
- 2)Improvement in spinal flexibility by goniometer
- 3)Improvement in disability due to LBP by Oswestry Disability Index (ODI)(1 month, 3 month)
- 4)Anabolic effect of therapy by improvement in serum IGF-1 level(1 month, 3 month)
- 5)Effect on body mass composition(1 month, 3 month)