Effectiveness of Homoeopathic Medicines with Physiotherapy as an adjunct in the management of Cervical Spondylosis: A Randomised Placebo Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The reduction in intensity of neck pain among patients with cervical spondylosis taking homoeopathic medicines with physiotherapy and those taking physiotherapy alone using Visual Analogue Scale (VAS).
研究概览
简要总结
This study is a randomized, placebo-controlled trial involving patients diagnosed with cervical spondylosis, confirmed by X-ray. Participants are divided into two groups based on randomization. One group will receive homeopathic medicine and physiotherapy, with homeopathic medicines administered in appropriate doses and potencies according to homeopathic principles, including repetition as needed. The other group will receive a placebo alongside physiotherapy. Each case will be reviewed every two weeks, with pain intensity measured using the Visual Analog Scale (VAS) at each visit. Disability will be assessed using the Oswestry Neck Disability Index at baseline, 3 months, and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients presenting with signs and symptoms of cervical spondylosis and characteristic X ray changes.
- •Age group 25 to 65 years of both sexes.
- •Cases with no disability (0-4) to moderate disability (15-24) according to Oswestry neck disability index.
排除标准
- •Patients with advanced degenerative changes in cervical region requiring surgical intervention.
- •Patient with serious complicated systemic illness.
- •Pregnant and lactating females.
- •Patients who are under any other treatment for the same complaint.
- •Diagnosed case of mental illness / psychiatric/ other uncontrolled/ life threatening illness affecting quality of life/ any organ failure.
- •Unwilling to take part and not giving consent to join the study or unable to read the patient information sheet.
- •Patients unable to comply with study protocol.
结局指标
主要结局
The reduction in intensity of neck pain among patients with cervical spondylosis taking homoeopathic medicines with physiotherapy and those taking physiotherapy alone using Visual Analogue Scale (VAS).
时间窗: Each case will be reviewed every two weeks, with pain intensity measured using the Visual Analog Scale (VAS) at baseline and then at every two weeks, till 6 months (24th week) of treatment.
次要结局
- The improvement in disability among patients with cervical spondylosis taking homoeopathic medicines with physiotherapy & those taking physiotherapy alone using Oswestry Neck Disability Index (NDI) as outcome measure.(Assessment with Neck disability questionnaire will be done at baseline, at 3 month(12th week) & then at 6 month (24th week) of treatment.)
研究者
Dr Bhawna
Dr B R Sur Homoeopathic Medical College, Hospital & Research Centre, Delhi - 110021