NCT02707094已完成不适用
A Pilot Study Examining the Efficacy of Biomodulator Treatment for Chronic Low Back Pain
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Change over time on the Numerical Rating Scale-11 Pain Score (NRS-11)
研究概览
简要总结
The purpose of this study is to determine the efficacy of self treatment with the Biomodulator device to decrease chronic low back pain (LBP) in active duty service members. In addition, the study will track the use of pain medication and the impact of pain on symptoms of anxiety, depression and Post Traumatic Stress Syndrome (PTSD).
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
- None
入排标准
- 年龄范围
- 18 Years 至 62 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •active duty Service Members (SMs) between the ages of 18 and 62, inclusive
- •history of chronic LBP (i.e. intermittent or continuous LBP symptoms present for 3 months or greater prior to entry into the study
- •participants must be using narcotic and/or non-narcotic oral analgesic medications to treat their chronic LBP symptoms on a weekly basis
- •must be able to speak and read English and understand the study procedures
排除标准
- •pacemaker or implanted electronic device
- •history of stroke, blood clots, or cardiac arrhythmias
- •pregnancy
- •no self-reported history of prescription medication abuse or sole-provider contract for prescribed narcotic medications
- •open wound over site of chronic pain;
- •history of spinal surgery
- •participation in a clinical trial for an investigational drug/ treatment within last 30 days
- •undergone treatment with TENS, biofeedback, or acupuncture within last 30 days
- •prior treatment with the Biomodulator
- •LBP "red flags": fever, trauma, progressive motor or sensory deficit, saddle anesthesia
- •participation in the study would delay the medical board (MEB) processing of the service member off of active duty status or would delay a return to duty status to their home unit
结局指标
主要结局
Change over time on the Numerical Rating Scale-11 Pain Score (NRS-11)
时间窗: Week 0, week 5, week 9
次要结局
- Change over time on the Oswestry Disability Questionnaire (ODQ)(Week 0, week 5, week 9)
- Change over time on the Generalized Anxiety Disorder - 7 (GAD-7)(Week 0, week 5, week 9)
- Change over time on the Interpersonal Relationships Inventory Short Form (IPRI-SF)(Week 0, week 5, week 9)
- 2 questions on treatment perception(week 5)
- Change over time on the Patient Health Questionnaire -9 (PHQ-9)(Week 0, week 5, week 9)
- Change over time on the Pittsburgh Sleep Quality Index (PSQI)(Week 0, week 5, week 9)
- Abbreviated acceptability rating profile - modified (AARP)(week 5)
- Change over time on the Posttraumatic Stress Disorder Checklist - Military (PCL-M) at week 5(Week 0, week 5, week 9)
- Change over time on the Quality of Life - Health Survey (SF-12)(Week 0, week 5, week 9)
- Change over time on oral consumption of analgesic medications(Week 0, week 5, week 9)
研究者
Ann Marie Nayback-Beebe, PhD, RN
COL
Brooke Army Medical Center
研究点 (2)
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