Effectiveness of individualized homoeopathic medicines in thetreatment of pain and stiffness in middle aged Lumbar Spondylosispatients: A single group, pre- post interventional study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Visual Analog scale (VAS) for pain and stiffness is a scale of 0 to 100 mm (“0†score indicate no
研究概览
简要总结
Lumbar Spondylosis is a degenerative process affecting the vertebral disc and facet joint of lumbar and sacral spine which at time causes nerve root compression, lumbar radicular pain, as well as musculoskeletal back pain, and stiffness in the low back region along with muscle spasm and tightness. The 2010 Global Burden of Disease Study estimated that low back pain is amongst the top 10 diseases that account for the highest no of disability adjusted life years worldwide. [6] Lumbar Spondylosis is responsibl for 10% of all low back pain. [2] Now a days it is very common in elder people but it has been found to be as high in athletes that is in middle age group. It is very frequently seen in middle aged to elderly population due to postural defect, in which the curves are emphasized and this result in the joint, muscle and vertebrae being in stressful position [7] In modern medicine, palliation through NSAID and EPIDURAL STEROID INJECTION can be done but this medication have side effects such as ulcer, bleeding, perforation etc. [2] Other physical therapy management can be beneficial but that only is not enough to manage lumbar spondylosis. There is no such study in the treatment of pain and stiffness in middle aged lumbar spondylosis patient and also as we know it is a degenerative condition of vertebral disc and facet joints of bones. Hence, I have decided to choose the topic lumbar spondylosis in middle age group of people if we can halt the degenerative process before hand with our individualized Homoeopathic medicine and also to see the effectiveness in treating the pain and stiffness in middle aged lumbar spondylosis patient.
Research Question -Do Individual Homoeopathic Medicines have role in the treatment of pain and stiffness in middle aged
lumbar spondylosis patient?
Hypothesis
Null Hypothesis (H0) There will be no significant changes in VAS scale and Oswestry Disability Index score in the treatment of pain and stiffness in middle aged lumbar spondylosis patient.
Alternative Hypothesis (HA) There will be significant changes in VAS scale and Oswestry Disability Index score in the treatment of pain and stiffness in middle aged lumbar spondylosis patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 45.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group is 45-60 years -Both sexes -Patient with chief complaint of pain and stiffness in low back region.
- •Patient is willing to give consent.
- •Patient is willing and able to follow all study instructions and to attend all study visit.
排除标准
- •Severe degeneration of lumbar and sacral spine.
- •Diagnosed case of uncontrolled life-threatening illness affecting quality of life.
- •Patient of pregnancy and lactation -Patient of malignancy -Immunocompromised patient -Inability to comply with the study protocol, alcoholic, drug users.
结局指标
主要结局
Visual Analog scale (VAS) for pain and stiffness is a scale of 0 to 100 mm (“0†score indicate no
时间窗: Outcome will be assessed initially at the baseline 4 weeks interval up to 6 months.
symptoms, whereas 100 mm indicates worst possible symptoms, before and after treatment
时间窗: Outcome will be assessed initially at the baseline 4 weeks interval up to 6 months.
次要结局
- Oswestry Disability Index Questionnaire. The scores of all questions answered are summed, then(multiplied by two to obtain the index (range 0-100). Where 0%-20%: minimal disability, 21%-40%:)