A Double-Blind, Randomized, Placebo-Controlled Study on Magnetic Field Therapy to Improve Chronic Lumbar Pain (Lbp)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- VAS Pain scores/ SF 15 Pain descriptors/ PGIF/
研究概览
简要总结
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.
详细描述
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
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male subjects age 18-
- •Capable of understanding and complying with study protocols.
- •Chronic lumbar pain for at least six months
排除标准
- •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.
结局指标
主要结局
VAS Pain scores/ SF 15 Pain descriptors/ PGIF/
次要结局
- Autonomic nervous system functions and range of motion