The open controlled clinical study to evaluate the effect of 10 days Marmatherapy on pain and mobility with special reference to Lumbar disc prolapse.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 1.Reduction in pain of lower back and legs.
研究概览
简要总结
Patients of lumbar disc prolapse at L-4 and L-5 are selected for the trial. Selection of patients will be done after the clinical examination and radiological examination of patient i.e. MRI spine. Allocation of patients in each group will be done by using lottery method. Marma therapy treatment will be given to 40 patients of experimental group for 10 days. 40 Patients in control group will be treated with Tab. doclofenac pottasium 50 mg with metaxalone 400 mg twice daily for 10 days. Evaluation of patient will be done before starting the treatment and after completion of treatment. Low back pain and leg pain will be measured with the help of visual analogous scale and improvement of mobility of spine will be assessed by measuring the angle of spine of forward flexion, side flexion and spine rotation with goniometry. Observations will be taken at 0 1 3 8 15 and 30th day .Treatment of patient will be withdrawn if patient develops any complications and who is irregular in follow up and compliance. All collected data will be assessed finally and will be analysed by unpaired t-test for evaluation of pain and spine mobility before and after treatment in both group and paired t -test will be apply to compare the results between control and experimental group. Conclusion will be drawn on the basis of findings of results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 25.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Clinically diagnosed patients of lumbar disc prolapse and confirmed by x-ray (lumbosacral spine AP & Lat view) and MRI spine 2.Age group between 25yrs to 45 yrs 3.Lumbar disc prolapse of L4-L5 4.Chronic Lumbar disc prolapse i.e. more than 3 weeks 5.Male and female 6.Controlled DM &HTN patients.
排除标准
- •1.Pregnant female 2.Paraplegia due to lumbar disc prolapse 3.Vertebral fracture, Potts spine 4.Kyphosis & Scoliosis 5.Rheumatoid arthritis, Spondyolisthesis, Ankylosing spondylitis patients
- •Benign & malignant tumors of vertebral column & spine
- •Metastatic deposits at spine
- •Metabolic disorders like Osteoporosis & Osteomalacia
- •HIV Positive & HbsAg positive patients.
结局指标
主要结局
1.Reduction in pain of lower back and legs.
时间窗: 10 Days
2.Improvement in movements of lower back and legs.
时间窗: 10 Days
次要结局
- 1. Forming of standard operating procedures of Marma Therapy in individuals with lumbar disc prolapse.
研究者
DR MADHURI VITTHALRAO BHANDARE
M A Podar Hospital worli Mumbai
