The Effect of Pulsed Electromagnetic Field Therapy on Patients With Low Back Pain
研究概览
详细说明
This study is a double-blind, placebo-controlled, randomized pilot study comparing usual care + PEMF with usual care + sham.
The investigators will recruit patients with LBP from the University of Bridgeport chiropractic clinic, and will enroll 80 total subjects: 40 with acute or subacute LBP, and 40 with chronic LBP. Within each of those populations the investigators will assign 20 subjects to receive usual care + PEMF, and 20 to receive usual care + sham. The investigators will track any other treatments initiated or discontinued during the trial.
Patients who agree to participate with be randomly given a functional PEMF device or a sham unit. Patients and clinicians will be blinded to the assignment. All subjects will be given the same instructions for daily use of the devices, and will continue to receive usual follow-up at the UBCC clinic as indicated. The investigators will collect patient-reported measures of pain and function pain at baseline, 6 weeks, and 12 weeks, and will collect data on adverse effects at each visit and at 6 and 12 weeks.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Anthony J Lisi
- 电话号码:203-576-4437
- 邮箱:alisi@bridgeport.edu
学习地点
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Connecticut
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Bridgeport、Connecticut、美国、06604
- 招聘中
- University of Bridgeport
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接触:
- Anthony J Lisi, DC
- 邮箱:alisi@bridgeport.edu
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接触:
- 电话号码:203-576-4437
-
-
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:
- UBCC patient
- complaint of LBP intensity 4/10 or greater on the Numerical Rating Scale
- diagnosis of a mechanical LBP condition
- age 18-70 years
- fluency in written and spoken English
- for female subjects, be postmenopausal, surgically sterile, abstinent, or agree to practice an effective method of birth control for the duration of the study if sexually active
- a willingness to participate in the study as evidenced by a signed informed consent form
Exclusion Criteria:
- current LBP complaint of 3/10 or less on the Numerical Rating Scale
- diagnosis or suspicion of LBP caused by cancer, infection, referred visceral pain, inflammatory arthropathy, or other non-mechanical process
- current or planned pregnancy
- any electrically-based implanted devices such as pacemakers defibrillators, spinal cord stimulators, insulin pumps; metallic implants (e.g. surgical fusion constructs, disc replacements) in the low back
- status post any lumbosacral spine surgery; significant mental health co-morbidities such as severe depression, schizoaffective disorders, suicidal ideation
- inability to understand and/or complete all components of the informed consent process without the assistance of another person (e.g. without proxy)
- inability to adhere to and comply with the treatment protocol.
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:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Acute/subacute; active device
MDCure active device
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Battery powered portable pulsed electromagnetic therapy device
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安慰剂比较:Acute/subacute; sham
MDCure sham device
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Battery powered portable pulsed electromagnetic therapy device
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实验性的:Chronic; active device
MDCure active device
|
Battery powered portable pulsed electromagnetic therapy device
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安慰剂比较:Chronic; sham
MDCure sham device
|
Battery powered portable pulsed electromagnetic therapy device
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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 |
---|---|---|
Change in pain intensity
大体时间:Baseline, weeks 6 and 12
|
Numerical Rating Scale
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Baseline, weeks 6 and 12
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Change in low back pain related disability
大体时间:Baseline, weeks 6 and 12
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Oswestry Disability Index
|
Baseline, weeks 6 and 12
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
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