A Pilot Study Examining the Efficacy of Biomodulator Treatment for Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 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
研究组 & 干预措施
Usual Care (Medication + Exercise)
Usual Care: Participants will receive guidance on over-the-counter and prescribed pain medications to use to treat their chronic low back pain symptoms. The Research Coordinator (RC) will provide instructions for low back pain stretching and strengthening exercises. The Licensed Provider (LP) will determine if any exercises should be excluded based on their physical limitations. Participants enrolled in the usual care treatment arm will track the frequency of their back stretching and strengthening exercise sessions on the Pain Medication & Exercise Diary. For the purpose of this study, treatment compliance will be met if participants complete the exercises a minimum of three times per week.
干预措施: Usual Care (Medication + Exercise) (Other)
Biomodulator + Usual Care
Biomodulator + Usual Care treatment group: Usual care, as described above, will be provided to all participants randomly allocated to this treatment group, in addition to treatment with the Biomodulator three times per week x 4 weeks. The licensed provider will review medication and treatment logs, prescribe pain medications as indicated, and assess for treatment side effects. In addition to treatment with the Biomodulator, the participant will perform back stretching and core strengthening exercises for a minimum of three times per week as instructed and will be told to use their prescribed pain medications as needed to self-treat their low back pain symptoms (as previously described above).
干预措施: Biomodulator (Device)
Biomodulator + Usual Care
Biomodulator + Usual Care treatment group: Usual care, as described above, will be provided to all participants randomly allocated to this treatment group, in addition to treatment with the Biomodulator three times per week x 4 weeks. The licensed provider will review medication and treatment logs, prescribe pain medications as indicated, and assess for treatment side effects. In addition to treatment with the Biomodulator, the participant will perform back stretching and core strengthening exercises for a minimum of three times per week as instructed and will be told to use their prescribed pain medications as needed to self-treat their low back pain symptoms (as previously described above).
干预措施: Usual Care (Medication + Exercise) (Other)
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 Generalized Anxiety Disorder - 7 (GAD-7)(Week 0, week 5, week 9)
- 2 questions on treatment perception(week 5)
- Change over time on the Oswestry Disability Questionnaire (ODQ)(Week 0, week 5, week 9)
- Change over time on the Interpersonal Relationships Inventory Short Form (IPRI-SF)(Week 0, week 5, week 9)
- 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