Study on Magnetic Field Therapy to Improve Chronic Lumbar Pain (LBP)
A Double-Blind, Randomized, Placebo-Controlled Study on Magnetic Field Therapy to Improve Chronic Lumbar Pain (Lbp)
OBJECTIVE:
The objective of this study is to determine if treatment with a flex pad impregnated with static/permanent magnets that can penetrate over 70 mm may improve the quality of chronic lumbar pain with reduction of pain scores.
HYPOTHESIS:
The researchers hypothesis that the application of a flex pad active magnetic therapy vs. sham if utilized daily during waking hours can reduce back pain and/or radicular pain. The null hypothesis is that treatment of subjects with chronic back pain with exposure to static/permanent magnetic fields have no measurable effect on chronic back pain scores and will be equal to the underlying placebo.
研究概览
详细说明
DESIGN:
This is a double-blind, randomized, placebo-controlled study which will consist of two treatment groups. Treated subjects will receive a static/permanent magnetic flex pad with a nominal strength of less than 1000 Gauss. Control subjects will receive physically identical flex pad without magnet with a nominal surface field strength of 0 Gauss (placebo). The magnets will be contained in a pad with a Velcro cover and subjects will wear the pad attached to their undergarments/skin during waking hours. Dr. Weintraub will examine participants initially to look for presence or absence of radiculitis, range of motion, presence of absence of spasm, etc. The primary outcome measures will be reduction of chronic low back pain in comparison with prior baseline scores. It is recognized that these changes are subjective in nature. Patients will maintain their VAS scores on a monthly basis and at the end of the study, individuals will return all forms and be reevaluated by Dr. Weintraub. They will be asked specific questions regarding PGIC for bias, etc.
研究类型
注册 (预期的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名:Michael I Weintraub, MD
- 电话号码:914-941-0788
- 邮箱:miwneuro@pol.net
研究联系人备份
- 姓名:Susan E. Wolert
- 电话号码:914-941-0788
- 邮箱:miwneuro@pol.net
学习地点
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New York
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Briarcliff Manor、New York、美国、10510
- 招聘中
- Michael I. Weintraub, MD
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接触:
- Susan E Wolert
- 电话号码:914-941-0788
- 邮箱:miwneuro@pol.net
-
接触:
- Michael I Weintraub, MD
- 电话号码:914-941-0788
- 邮箱:miwneuro@pol.net
-
-
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:
- Female or male subjects age 18-80.
- Capable of understanding and complying with study protocols.
- Chronic lumbar pain for at least six months
Exclusion Criteria:
- Unable to understand informed consent (mental retardation, psychosis, communicative impairment).
- Cardiac pacemaker or other mechanical internal devices.
- Tumor in the spine/history of malignancy or tumor.
- Pregnancy.
- Prior spine surgery.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
研究衡量的是什么?
主要结果指标
结果测量 |
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VAS Pain scores/ SF 15 Pain descriptors/ PGIF/
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次要结果测量
结果测量 |
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Autonomic nervous system functions and range of motion
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合作者和调查者
调查人员
- 首席研究员:Michael I. Weintraub, MD、Phelps Memorial Hospital
研究记录日期
研究主要日期
学习开始
研究完成
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.
腰背疼痛的临床试验
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University尚未招聘
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Daiichi Sankyo招聘中
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Université Victor Segalen Bordeaux 2Nanox International Laboratory (Belgique)完全的
Magnetic Flex Pad的临床试验
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Circassia LimitedCetero Research, San Antonio; Adiga Life Sciences, Inc.完全的
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Pluristem Ltd.未知严重肢体缺血 (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