Add on effect of homoeopathy to yoga in the management of lumbar spondylosis: A randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- The Bournemouth questionnaire (BQ) score for pain
研究概览
简要总结
Low back pain is a common musculo-skeletal disorder with a 70% lifetime prevalence that causes major economic losses through medical and lost work days costs. The occurrence of low back pain in Indian population is alarming with nearly 60% to 80% of the people in this country have suffered from low back pain at some time during their lifespan. Low back pain is a leading cause of disability. Conventional medical treatment have many side effects. CAM therapy is being popular in patients with musculo-skeletal disorders including LBP. There are several studies showing that the homoeopathic medicines and yoga practices are effective in LBP but the studies showing comparative as well as additive effect of homoeopathy and yoga in chronic LBP are lacking even after going through different search portals. To fulfil this research-gap this RCT will be conducted following the strict guidelines as per the protocol. In this project, we intend to compare the effect of individualized homoeopathy with add-on to Yoga practices (YP) and patients on Yoga practices (YP) alone in 72 patients suffering from chronic low back pain due to lumbar spondylosis using Bournemouth questionnaire and Modified Oswestry disability questionnaire (MODQ) at baseline and every month up to 3 months of study at Dr. Anjali Chatterji Regional Research Institute for Homoeopathy, Kolkata, West Bengal, India. It is an open label, randomized (1:1), parallel arm, comparative trial. The generated results will undergo statistical analysis and will be published in scientific journal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age between 30 to 70 years.
- •2.Both male and female patients.
- •3.Participants with chronic low back pain due to lumbar spondylosis (M47.8) of more than 3 months duration.
- •4.Participants with a radiological diagnosis of lumbar spondylosis with mild to moderate degenerative radiological changes.
- •5.A pain intensity of 5 or higher on a numerical rating scale of 0 to 10 is required for enrollment.
- •Washout phase of conventional or other medications for lumbar spondylosis, if any of, 2 weeks prior to enrollment.
- •7.Participants who are willing to give informed consent to participate in the study.
排除标准
- •Participants with severe degenerative changes as found radiologically and those with major spinal disorders associated with LS.
- •Low back pain with systemic disorders (i.e., Primary joint disease such as active rheumatoid arthritis; Metabolic bone disease; Malignant bone disease; Uncontrolled DM and HTN, Cardiovascular, CKD and other severe illness, not able to consultation)
- •Pregnancy or lactation
- •Critically patients requiring orthopedic corrections
- •Substance abuse, alcoholism
- •Psychologically unstable patients.
结局指标
主要结局
The Bournemouth questionnaire (BQ) score for pain
时间窗: Baseline and every month up to 3 months
次要结局
- Measurement of back-related disability through Modified Oswestry disability questionnaire (MODQ) for Indian population(Baseline and every month up to 3 months)
- Modified Naranjo Criteria for Homeopathy (MONARCH) may be taken as secondary outcome for evaluating the causal attribution between the given intervention and the clinical improvement at the end of treatment.(At the end of study i.e., after 3 months of study)