An exploratory, open-label, randomized, controlled, pilot trial comparing the effects of individualized homoeopathic medicines in LM potencies with centesimal potencies in managing chronic low back pain in adults
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- To explore feasibility of a definitive future trial
研究概览
简要总结
Chronic low back pain is defined by the persistence of pain beyond 12 weeks of symptoms, contributing to anxiety, depression, disability, sleep disturbances, poor quality of life. Low back pain is one of the most prevalent musculoskeletal disorders affecting people of all ages and is a major cause of disease burden globally. After upper respiratory tract illness, low back pain ranks as the second most common reason for absenteeism from work. Over 5 million people are incapacitated by low back pain, and about 25 million people lose work as a result. Smoking, heredity and recurrent trauma are recognized risk factors for progressive lumbar degenerative changes. Persistent pain and emotional anguish are also associated with chronic musculoskeletal diseases, and they are frequently the main complaints of patients. Compared to people without LBP, those who have it are more prone to experience anxiety or depression. This association has been seen in a number of prevalence studies, such as recent research of the general population in Qatar, which found that those with LBP had greater rates of anxiety disorders (9.5% vs. 6.2%) and depression ( 13.7% vs. 8.5%) than people without LBP. High - quality guidelines state that exercise, manual therapy acupuncture, paracetamol, or NSAIDs may be used to manage patients with chronic low back pain. Statistical pooling of 4 RCTs demonstrated that homoeopathic medications in centesimal potencies considerably reduced chronic low back pain, significantly better than placebo. In case of LM potency, no such trials have been conducted. So, centesimal potency is regarded as the control group in this experiment due to the success of prior investigations. An open-label, randomized (1:1), centesimal controlled trial will be conducted on 102 adults who are suffering from chronic low back pain at the outpatient’s department of D. N. De Homoeopathic Medical College and Hospital. This study will explore the feasibility of a definitive future trial and assessment will be done by Oswestry Disability Index (ODI) and Depression, Anxiety, Stress Scale Short Form (DASS -21) -both are secondary outcomes; at baseline, every month, up to 3 months. Comparative analysis will be carried out to detect group differences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Age group 18-65 years
- •Participants of either sex or transgender
- •Patients suffering from low back pain for 3months or more
- •Patients suffering from moderate and severe pain; using Numeric Rating Scale (NRS).Patients will be categorized into mild (NRS 0-3), moderate (NRS 4-7) or severe (NRS 8-10).
- •Patients with radiological diagnosis indicating different causes of low back pain, mild to moderate degenerative radiological changes.
排除标准
- •Unwilling to take part and not providing with written informed consent of participation.
- •Patients who have undergone spine surgery within 6 months.
- •Patients with severe degenerative changes in radiological findings like congenital abnormalities, infection, tumour, malignancy.
- •Patients having severe and extremely severe DASS-21 score (severe depression-11-13, anxiety-8-9, stress-13-16 and extremely severe depression-14+, anxiety -10+, stress-17+)
- •Immuno-compromised state, AIDS, hepatitis et
- •Uncontrolled diabetes, hypertension, cancer or any other systemic illness or any vital organ failure.
- •Tobacco chewing and/ or smoking, alcoholism and/ or any form(s) of substance abuse and/ or dependance (TAPS tool)
- •Pregnancy, puerperal women and lactating mother.
- •Undergoing homoeopathic treatment for any chronic disease within last 6months.
- •Simultaneous participation in any other clinical trial.
结局指标
主要结局
To explore feasibility of a definitive future trial
时间窗: 3 months
次要结局
- Oswestry Disability Index (ODI)(Baseline, every month, up to 3 months)
- Depression, Anxiety, Stress Scale Short Form (DASS-21)(Baseline, every month, up to 3 months)
研究者
Deepsikha Chakrabarty
D N De Homoeopathic Medical College and Hospital
