Effects of a Mechanical Needle Stimulation Pad on Chronic Low Back Pain (NRM_2009)
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.
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- chronic or recurrent low back pain in the past 12 months
- average pain intensity 4 out of 10 points
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Needle stimulation pad
a self-administered treatment with a mechanical needle stimulation pad, a mechanical device to be used for 30 minutes daily for 14 days.
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其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pain intensity
大体时间：day 14
|
Visual analogue scale
|
day 14
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pain intensity
大体时间：Week 14
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Visual analogue scale
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Week 14
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Oswestry Low Back Pain Disability Index
大体时间：Day 14
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Day 14
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Oswestry Low Back Pain Disability Index
大体时间：Week 14
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Week 14
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Short Form 36 Health Survey Questionnaire (SF-36)
大体时间：Day 14
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Day 14
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Short Form 36 Health Survey Questionnaire (SF-36)
大体时间：Week 14
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Week 14
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Fear Avoidance Beliefs Questionnaire (FABQ)
大体时间：Day 14
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Day 14
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|
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Fear Avoidance Beliefs Questionnaire (FABQ)
大体时间：Week 14
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Week 14
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Experiences with the intervention
大体时间：Day 14
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Open question: "please indicate observed changes"
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Day 14
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Medication use
大体时间：Day 14
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Use of medication, daily log
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Day 14
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Number of any adverse events
大体时间：Day 14
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Day 14
|
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Pain intensity measured immediately after the application, visual analogue scale
大体时间：5 minutes
|
5 minutes
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合作者和调查者
调查人员
- 首席研究员：Gustav Dobos, Professor、University of Duisburg-Essen
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Needle stimulation pad的临床试验
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Centre Hospitalier Universitaire de Nīmes完全的
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Circassia LimitedCetero Research, San Antonio; Adiga Life Sciences, Inc.完全的
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Pluristem Ltd.完全的严重肢体缺血 (CLI)德国, 英国, 匈牙利, 美国, 保加利亚, 捷克语, 以色列, 北马其顿, 波兰