Efficacy of individualized homoeopathic medicines in the treatment of sciatica pain in adults: A Double-blind, randomized, placebo-controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Roland Morris Pain and Disability Questionnaire (RMPDQ)
研究概览
简要总结
Sciatica is a clinical condition that is classically characterized by a sense of excruciating pain and paraesthesia along the course of the sciatic nerve, with a serious impact on the quality of life of those affected. Sciatica is estimated to occur in about 30% of LBP episodes, with an annual incidence of 1% to 5%. Homeopathy is a frequently used therapy to treat sciatic pain; however, the research evidence is limited. This 3-month, double-blind, randomized, placebo-controlled trial is aimed at evaluating the efficacy of homeopathic medicines in the treatment of sciatica pain in 72 adults. The primary outcome measure is RMPDQ; the secondary outcomes are SF-MPQ, OLBPDQ, and MYMOP-2 questionnaires, all measured at baseline and every month, up to 3 months. Comparative analysis will be carried out to detect group differences. Results will be published in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of age group 18 to 65 years
- •Either sex or transgender
- •Cases experiencing low back pain radiating to the lower limb (unilateral or bilateral) for 3 month or more (2018/2019 ICD-10-CM diagnosis code M54.3), confirmed by straight leg raising (SLR) test and as diagnosed clinically by the consultant orthopaedic and spine surgeon, and/or MRI as and when necessary.
排除标准
- •Denying informed consent
- •Cases suffering from uncontrolled systemic disease or infections.
- •Diagnosed or suspected cases of malignancy or metastasis or any SOL in spine, red flag signs like progressive neurological deficit, bowel/bladder dysfunction, unexplained weight loss, recent trauma, and infection.
- •Having a history of low back surgery in the past 6 months.
- •Undergoing any medicinal treatment during 6 weeks before enrolment in the study;
- •Pregnancy, nursing mothers, and puerperal women.
- •Self-reported immune-compromised state.
- •Patients with psychiatric disease.
- •Chewing tobacco, smoking, alcoholism, substance misuse in any form, and/or dependence (TAPS tool)
- •Receiving homoeopathic treatment for a chronic illness all through the previous three months.
- •Simultaneously taking part in any other clinical trial.
结局指标
主要结局
Roland Morris Pain and Disability Questionnaire (RMPDQ)
时间窗: Baseline, and every month, up to 3 months
次要结局
- Short Form McGill Pain Questionnaire (SF-MPQ)(Baseline, and every month, up to 3 months)
- Oswestry Low Back Pain Disability Questionnaire (OLBPDQ)(Baseline, and every month, up to 3 months)
- Measure Yourself Medical Outcome Profile v.2 (MYMOP-2)(Baseline, and every month, up to 3 months)
研究者
Khushboo Pandey
D N De Homoeopathic Medical College and Hospital