Comparative study between churna pinda Sweda with Yoga therapy and Yoga therapy alone in chronic low back pain: A prospective randomized open-label study.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- 1.Change in low back pain intensity score from baseline for Churna Pinda Sweda (CPS) with Yoga therapy after 30 days of intervention.
研究概览
简要总结
This is a randomized open label clinical study will be conducted in the Department of AYUSH, AIIMS, Bhubaneswar for chronic low back pain (CLBP) patients aged between 18 to 60 years from both sex with intervention of Churna Pinda Sweda (CPS) and Yoga therapy. Blocks randomization will be selected for enrolment of the participants. Patients recruited in group A will be treated with CPS for 15 days and continue Yoga for 30 days. And in group B, patients will be advised to continue Yoga for 30 days. Assessment will be done after completion of 30 days of treatment. The primary objective will be to compare the effectiveness of CPS with Yoga therapy and Yoga therapy alone in CLBP. Primary outcomes will be change in low back pain intensity score from baseline for CPS with Yoga therapy, and change in low back pain intensity score from baseline for Yoga therapy, to compare the low back pain intensity score for CPS with Yoga therapy and Yoga therapy alone. Secondary outcomes will be change in disability score from baseline for CPS with Yoga therapy, change in disability score from baseline for Yoga therapy, and to compare the disability score between CPS with Yoga therapy and Yoga therapy alone. The total duration of study will be 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Willingness to participate in research
- •Primary complaint of low back pain for more than three months.
- •Age should be between 18 years to 60 years.
- •Patient whose Numeric pain rating score (NPRS) ≥ 3.
排除标准
- •Congenital spinal disorders
- •Chronic systemic illness 3.H/O Previous surgery of the spine
- •Patient with spondylolisthesis, fracture, osteoporosis, etc.
- •Malignant bone disorders
- •Evidence of radiculopathy
- •Severe psychiatry disorder
- •Pregnant women
- •Infectious disease.
- •Patients with h/o taking analgesics should be excluded.
结局指标
主要结局
1.Change in low back pain intensity score from baseline for Churna Pinda Sweda (CPS) with Yoga therapy after 30 days of intervention.
时间窗: 1.Low back pain intensity score at baseline, after 15 days and 30 days of treatment.
2.Change in low back pain intensity score from baseline for Yoga therapy after 30 days of interventions.
时间窗: 1.Low back pain intensity score at baseline, after 15 days and 30 days of treatment.
3.To Compare the low back pain intensity score for Churna Pinda Sweda (CPS) with Yoga therapy and Yoga therapy alone after 30 days of interventions.
时间窗: 1.Low back pain intensity score at baseline, after 15 days and 30 days of treatment.
次要结局
- 1.Change in disability score from baseline for Churna Pinda Sweda (CPS) with Yoga therapy(2.Change in disability score from baseline for Yoga therapy.)
研究者
Prasanta Kumar Sahoo
All India Institute of Medical Sciences Bhubaneswar