Effects of a Mechanical Needle Stimulation Pad on Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 主要终点
- Pain intensity
研究概览
简要总结
The needle stimulation pad is a self-care device, which has been promoted for pain control and well-being. The aim of the study was to test the efficacy of the pad for chronic/recurrent low back pain treatment.
Patients with non-specific chronic or recurrent low back pain were selected from a large health insurance company database and advised to use the pad daily for two weeks; outcomes were assessed at baseline, weeks 2 and 14. Primary outcome measure was pain intensity at week 2; secondary outcome measures included the Oswestry disability index (ODI), health-related quality of life (SF-36), the fear avoidance beliefs questionnaire (FABQ), analgesic medication consumption and safety.
详细描述
see above
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •chronic or recurrent low back pain in the past 12 months
- •average pain intensity 4 out of 10 points
排除标准
- •malignant back pain
- •congenital deformities of the spine
- •dystonia or other movement disorders
- •spinal surgery within 12 months prior
- •pregnancy
- •dermatological diseases in the areas treated
- •tendency for hemorrhages
- •severe mental illness
- •recent treatment with anticoagulation, corticoid medication, acupuncture
结局指标
主要结局
Pain intensity
时间窗: day 14
Visual analogue scale
次要结局
- Experiences with the intervention(Day 14)
- Short Form 36 Health Survey Questionnaire (SF-36)(Week 14)
- Number of any adverse events(Day 14)
- Pain intensity measured immediately after the application, visual analogue scale(5 minutes)
- Pain intensity(Week 14)
- Oswestry Low Back Pain Disability Index(Week 14)
- Fear Avoidance Beliefs Questionnaire (FABQ)(Week 14)
- Medication use(Day 14)
研究者
Gustav Dobos
Principle Investigator
Universität Duisburg-Essen