Role of individualized homoeopathic medicines in the treatment of low back pain in sedentary lifestyle an open label prospective single arm pre and post clinical study.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The outcome assessment of the patients shall be calculated as per changes in Standard scoring systems Oswestry low back pain disability questionnaire and The STarT Back Screening score level .
研究概览
简要总结
Ø With the research question of can individualized homeopathic medicine demonstrate significant improvement in patients suffering from low back pain in sedentary lifestyle. Participants fulfilling the inclusion & exclusion criteria shall be included in the study. with the aim to establish the role of individualized homoeopathic medicines in patient suffering from low back pain in sedentary lifestyle. with the primary objectives to determine the changes in the Oswestry low back pain disability questionnaire (ODQ) after 6 months individualized homoeopathic medicine and to find out the changes in the quality of life of patients with low back pain using STarT Back Screening Tool after 6 months individualized treatment.Study period is 18 months including 6 months of follow up of each case (at least 4 months**).**the calculated sample size is 45 considering 10% drop out, the target sample size is 50.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed and stable patient suffering from low back pain with history sedentary lifestyle.
- •Patient fulfilling the criteria of sedentary lifestyle according to short version of the International Physical Activity Questionnaire (IPAQ).
- •Age 18-65 years.
- •Both sexes.
- •Ability to read or understand Bengali or Hindi or English.
- •Providing written informed consents.
排除标准
- •Cases require immediate surgical intervention or life support measures.
- •Cases suffering from uncontrolled systemic illness or life-threatening infections.
- •Unwilling to take part and not giving consent to join the study.
- •Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure.
- •Pregnant women and lactating mothers Substance abuse and/or dependence.
- •Self-reported immune-compromised state, and Undergoing homoeopathic treatment for any chronic disease within last 6 months.
结局指标
主要结局
The outcome assessment of the patients shall be calculated as per changes in Standard scoring systems Oswestry low back pain disability questionnaire and The STarT Back Screening score level .
时间窗: At baseline and 6 months
次要结局
未报告次要终点
研究者
Roshni ratre
National institute of homoeopathy