Estimation of Therapeutic Effect of MDcure on Patients With Chronic Back Pain
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Improvement in pain in placebo group
研究概览
简要总结
This study will assess the therapeutic effect of MDcure® device. MDcure® is an FDA Class 1 listed medical device, produced to ISO-13485 standards, that delivers extremely low intensity (nano Tesla; 10-9) and low frequencies (1-100 Hertz) electromagnetic fields (EMF) intended to reduce muscular aches and pains particularly of the lower back.
assessing the reduction of lower back pain. Half of participants will receive the MDcure device, while the other half will receive a mock device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18-75
- •Patients with chronic lower back for more then 3 month
- •Patients who scored over 21% and below 60% in the Oswestry questionnaire
排除标准
- •A neurological deficient in lower limbs
- •Patients who scored more than 60% on the Oswestry questionnaire.
- •Patients who underwent surgical intervention in spine including metal implant in lower back
- •Patients diagnosed with cancer
- •Patients with any type of vertebral fracture
- •Patients who received steroid injection less then a month prior to starting the experiment
- •Patients treated with steroids as a preventive treatment on a regular basis
- •Patients using narcotic drugs for over a six month period or cannabis or any other sort of narcotic drug for over a six month period prior to their enrollment in the study
- •Pregnant women
研究组 & 干预措施
Placebo
干预措施: Mock Device (Other)
Experimental
干预措施: MDcure (Device)
结局指标
主要结局
Improvement in pain in placebo group
时间窗: 6 weeks
Assessment of rate of patients from the placebo group who report improvement in pain above 20% in Oswestry scale
Improvement in pain in experiment group
时间窗: 6 weeks
Assessment of rate of patients from the experiment group who report improvement in pain above 20% in Oswestry scale
次要结局
- Assess period of time to attain improvement(maximum of 6 weeks)
研究者
Dr. Eran Segal
Principal Investigator
Assuta Medical Center