Management of chronic low back pain with individualized homoeopathic medicine in adult population with special emphasis on accessory circumstances: an open label single arm pre and post clinical study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- 1.To measure the changes in Oswestry Disability Index (ODI) questionnaire after 3 months of intervention.
研究概览
简要总结
Low back pain is defined as pain and discomfort, localized below the costal margin and above the inferior gluteal folds, with or without leg pain.[21] Pain that lasts longer than three months (Merskey 1986) and is restricted to the area bounded by, the L1 vertebrae above, and the S1 vertebrae below, and the erector spinae muscles laterally is referred to as Chronic low back pain (CLBP). An estimated 619 million people worldwide were predicted to have low back pain in 2020. Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies (CH). Each dose will consist of 1 cane sugar globules no. 20 moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue in empty stomach; dosage and repetition depending upon the individual requirement of the cases. Duration of therapy: 3 months with monthly follow-ups. It is a open label, single arm, interventional study.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients suffering from chronic low back pain (ICD -11 code MG30.02)
- •Participants fulfilling AAPT Diagnostic criteria for Chronic Musculoskeletal Low Back Pain Dimension 1
- •Age between 18 to 60 years
- •Patients with radiological diagnosis indicating different cases of low back pain with mild to moderate degenerative radiological changes.
- •Patient of either sex.
- •Patient given written consent to participate.
排除标准
- •Patient not willing to participate in study.
- •Patient too sick for consultation.
- •Patients with severe degenerative changes in radiological findings like spinal abnormalities, malignancy, fracture, cauda equina syndrome, infection, ankylosing spondylitis, epidural abscess, congenital abnormalities, etc.
- •Patient with history of spinal surgery or requiring or willing for the same.
- •Patient undergoing Homoeopathic treatment for chronic disease within last 6 weeks.
- •Non-ambulant patient.
- •Obese patient (BMI 30.0 or more)
- •Patient with uncontrolled diabetes, hypertension, cancer, any other systemic illness or vital organ failure.
- •Vulnerable population- unconscious, differently abled, terminally ill, or critically ill patients, institutionalized subjects, mentally incompetent, patients with psychiatric illness.
- •Patients with immunocompromised state.
- •Pregnant and puerperal woman, lactating mother.
- •Patients with habits of tobacco chewing, and or smoking, alcoholism, and or any other forms of substance abuse and or dependence.
- •Simultaneous participation in any other clinical trial.
结局指标
主要结局
1.To measure the changes in Oswestry Disability Index (ODI) questionnaire after 3 months of intervention.
时间窗: At Baseline and 3rd month
次要结局
- 1.To measure the changes in the pain intensity in Numerical Pain Rating Scale(2.To measure the changes in EQ-5D-5L Questionnaire)
研究者
Dr Arnab Ranjan Das
The Calcutta Homoeopathic Medical College and Hospital