The Kyrobak Continuous Passive Motion Device for the Treatment of Chronic Low Back Pain: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in Amount of Pain Determined by the NRS at the End of the 3-week Treatment Plan Compared to Baseline (Before Treatment)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of the Kyrobak continuous passive motion home-use device in relieving low back pain, improving proprioception (balance and fall prevention) and improving the symmetry of muscle function on either side of the spine.
详细描述
The Kyrobak is an electrically operated, continuous passive motion device including a platform that performs angular oscillations. The Kyrobak is used at home as an aid to relieve mild-to-moderate low back pain.
The study is designed to evaluate the efficacy of daily home use of the Kyrobak for 3 weeks and to assess the sustained efficacy 1 week later.
The evaluation will include the level of pain using the numerical rating scale (NRS), Digital Posturography, Heart Rate Variability (HRV), Static Surface Electromyography (SEMG), a condition-specific low back pain disability status by the Oswestry Disability Index (ODI) and subject satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age 18 or older
- •Level of pain - mild to moderate low back pain (≤5 NRS pain)
- •Chronic - symptoms must have been present for at least 12 weeks or more.
- •Location - lower tip of scapula to back of pelvis
- •Etiology - non-specific
排除标准
- •Patients who have low back pain due to specific and known causes (infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammatory process, radicular syndrome (radiating nerve pain from the spine such as sciatica), cauda equinal syndrome (serious neurological disorder where the spinal nerve roots are compressed which can cause).
- •Weight in excess of 265 lbs. (120.4 kg)
- •Pregnant or breastfeeding
- •Recent history of violent trauma
- •History of previous back surgery
- •Constant progressive, non-mechanical pain (no relief with bed rest)
- •Chronic pain other than low back pain
- •Past medical history of malignant tumor
- •Has taken an investigational drug within the past 30 days prior to entering the study, or currently enrolled in another investigational study
- •Mental disorder that would lead to difficulty in questionnaire completion
- •Any litigation for low back pain
- •Prolonged use of corticosteroids (i.e. used for 3 months or more)
- •Present use of prescription pain medication (i.e. Percocet®, Oxycodone, Vicodin®, etc.)
- •Physical disability that prevents the subject to lie down/get up
- •Drug abuse, immunosuppression, HIV
- •Any other condition which in the physician's opinion would make it unsafe for the subject to be treated.
结局指标
主要结局
Change in Amount of Pain Determined by the NRS at the End of the 3-week Treatment Plan Compared to Baseline (Before Treatment)
时间窗: 3 weeks
Pain level will be scored by the subject using the NRS on a 0 to 10 scale where 10 represents the highest level of pain and 0 represents no pain.
次要结局
- Change in Functional Health Status by ODI(3 weeks, 4 weeks)
- Change in Proprioception and Vestibular Function.(3 weeks, 4 weeks)
- Change in Symmetry of Muscle Function on Either Side of the Spine(3 weeks, 4 weeks)
- Change in Heart Rate Variability (and the Autonomic System)(3 weeks, 4 weeks)