A double-blind, randomized, placebo-controlled trial of individualized homoeopathic medicines in managing neck disability in cervical spondylosis in adults
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Neck Disability Index (NDI)
研究概览
简要总结
The osteo-cartilaginous components of the cervical spine are impacted by cervical spondylosis (CS), a chronic degenerative disorder of the spine. With a worldwide frequency that ranges from 10% to 17.6%, cervical spondylosis is a well-known public health issue that affects people of all ages and in a variety of nations . According to the global burden of disease study of 2013 , in 301 acute and chronic diseases and injuries in 188 countries, neck pain was one of the top 10 causes of years lived with disability.Many patients use complementary and alternative medicine (CAM), including homeopathy, to prevent, control, and manage their rheumatologic disorders. However, scientific research has not yet fully proven the efficacy of complementary and alternative medicine (CAM) as a treatment for rheumatologic illnesses, such as Cervical Spondylosis and the findings have remained unclear . Homeopathy may have immense potential to offer in successful treatment of pain of cervical spondylosis but the available data shows contradictory results . Under such circumstances, we intend to undertake this research project ‘A double blind, randomized, placebo-controlled trial of individualized homoeopathic medicines in managing neck disability in cervical spondylosis in adults’.A double-blind, randomized (2:1), placebo-controlled trial will be conducted on 126 adults who are suffering from neck disability due to cervical spondylosis at the outpatient’s department of D. N. De Homoeopathic Medical College and Hospital. Assessment will be done by Neck Deformity Index (NDI) [Primary outcome measure], Pain NRS scale [Secondary outcome measure], MYMOP-2 questionnaire [Secondary outcome measure] 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
- 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
- •Patient with age group 18-65 yrs.
- •1.Participants of either sex or transgender.
- •2.Patient suffering from Cervical Spondylosis verified by clinical examination as well as X ray findings.
- •3.Patient with mild to moderate neck pain.
- •according to NDI score 5-24.
排除标准
- •1.Not providing with written informed consent of participation.
- •2.Severe degeneration of Cervical Spine with marked degeneration of vertebrae, having neck trauma/fracture/history of surgery/congenital spinal abnormalities, any systemic disease of bones and joints and other non- specific neck pain lesion.
- •3.Non-ambulant patients.
- •4.Immune compromised state.
- •5.Substance abuse or dependence 6.Too unwell to take part.
- •7.Patient with unstable psychiatric disorder.
- •8.Pregnancy and puerperal and Lactating women.
- •9.Patient with severe neck pain.
- •10.Undergoing homoeopathic treatment for any chronic disease within last 6 months.
- •11.Simultaneous participation in any other clinical trial.
结局指标
主要结局
Neck Disability Index (NDI)
时间窗: Baseline, and every month, | up to 3 months
次要结局
- Pain 0-10 Numerical Rating Scale (NRS)(Baseline, and every month,)
- Measure Yourself Medical Outcome Profile version 2 (MYMOP-2)(Baseline, and every month,)
研究者
Dr Sayani Debnath
D N De Homoeopathic Medical College and Hospital
