Double Blind, Randomized, Sham-Controlled Study on the Effects of Neuro-Stim System on Pain, Sleep, and Opioid Use in Pain Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Pain Measured Via the Defense and Veterans Pain Scale v2.0 (DVPRS)
研究概览
简要总结
The purpose of this study is to evaluate the ability of Neuro-Stim System, a non-pharmacologic alternative for pain management, to reduce pain and treat insomnia. Neuro-Stim System uses electrical current to stimulate neurovascular bundles (nerves) in the ear and possibly the autonomic nervous system.
详细描述
Pain is a complex problem that complicates recovery and rehabilitation after traumatic injury and surgery. The physician must balance pain management therapies against the potential for side effects and complications. Most of the treatment options for pain are pharmacological and have the potential for serious side effects and drug interactions. A non-pharmacological treatment would reduce the risk of adverse events and likely enhance the overall multimodal pain plan. The purpose of this study is to evaluate the effectiveness of Neuro-Stim System (NSS), a non-pharmacological option that uses electrical current to stimulate neurovascular bundles (nerves) in the ear and possibly the autonomic nervous system, to treat pain and improve sleep. Pain patients will be asked to participate in a study to evaluate the ability of Neuro-Stim System to reduce pain and to treat insomnia. NSS is a Federal Drug Administration (FDA) approved device intended to be used for chronic and acute pain.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Subjects must be inpatients (at Walter Reed National Military Medical Center) at the time of study enrollment and study device placement.
- •Any patient experiencing post-operative pain (visceral, somatic, or neuropathic) and has a pain score (measured via DVPRS v2.0) equal to or greater than 4 for at least 3 hours in the past 24 hours.
- •Has an intact external ear where device can be placed
- •The skin of the ear at placement site must be free of infection
- •The participant cannot have been on regularly scheduled central acting opioids for more than 30 days continuously leading up to the initiation of the study. However, intermittent, breakthrough opioids are permissible, but the potential subject must have a current opioid prescription.
- •The participant must have vital signs (HR/breathing/blood pressure) within normal limits.
- •Able to understand English and verbalize their pain level.
排除标准
- •Have inconsistent vital signs (fluctuating, extremely low blood pressure, tachycardia, etc.)
- •Wear any time of implanted electrical device such as a brain shunt, vagal stimulator, pace maker, spinal pain pump, etc.
- •Pregnant (by results of preoperative Human Chorionic Gonadotropin or hCG urine or blood testing)
- •Has a history of skin allergy to metals
- •unwilling to voluntarily participate
- •hemophilia
- •Psoriasis vulgaris on ears
结局指标
主要结局
Pain Measured Via the Defense and Veterans Pain Scale v2.0 (DVPRS)
时间窗: baseline to 5 days
The primary outcome is pain measured by the Defense and Veterans Pain Rating Scale (DVPRS) from 0-10 at baseline, 15 minutes, and daily for 5 days after application. Rate the severity of your CURRENT pain: 0 - No Pain 1. - Hardly notice pain 2. - Notice pain, does not interfere with activities 3. - Sometimes distracts me 4. - Distracts me, can do usual activities 5. - Interrupts some activities 6. - Hard to ignore, avoid usual activities 7. - Focus of attention, prevents doing daily activities 8. - Awful, hard to do anything 9. - Can't bear pain, unable to do anything 10. - As bad as it could be, nothing else matters Higher values represent worse outcomes
次要结局
- Modified PROMIS for Pain Intensity(baseline to 10 days)