Neurolumen for Chronic Lower Back Pain: A Pilot RCT Study
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Defense and Veterans Center for Integrative Pain Management
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain Intensity
概览
简要总结
This study will evaluate the impact of the Neurolumen medical device on chronic low back pain.
详细描述
Chronic low back pain is debilitating and difficult to treat. The commercially-available Neurolumen medical device uses a combination of electrical stimulation, low-level laser, and LED therapies to treat pain. Separately, each of these treatments has shown promise for treating chronic pain. In a recent survey by the manufacturer involving over 4700 Veterans who were prescribed a Neurolumen device through their local VA facility, 93% of patients reported a reduction in pain levels, and 52% report reduction in medication, including 6% who reported cessation of all medication. Additionally, average pain levels of 7.01/10 dropped to 3.38/10 after 6 weeks of use (unpublished data). Thus, there is theoretical support and preliminary evidence for the utility of Neurolumen for treating chronic pain; yet, it is unknown whether these findings generalize to other populations. Furthermore, while a reduction in retrospective pain and medication use are promising, prospectively-collected clinical outcomes of Neurolumen use have yet to be examined. This study will examine the feasibility and efficacy of the Neurolumen devices for treating chronic lower back pain using a double-blind pilot randomized controlled trial design with a placebo/waitlist control.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with LBP with an average pain score of 4 or higher on DVPRS for \> 3 months
- •Ability to sit or lay down for 30 minutes during treatments
- •Demonstrated ability to correctly use the device and maintain adequate sensor contact throughout (assisted or unassisted)
- •Female participants who could possibly become pregnant must agree to use a highly effective contraceptive method from the screening period through the 4 weeks of study intervention and any use during the wait-list control period. These methods include a physical barrier method (e.g., condom) plus an additional hormonal, IUD, tubal ligation, or second type of barrier (e.g., diaphragm). In addition, they must abstain from egg collection or donation during the same period.
排除标准
- •Individuals \< 18 or \>70 years of age at enrollment
- •Persons with Pacemakers, or interstitial pumps, or spinal cord stimulator in ON mode.
- •Persons who have received back surgery (open) within the last 3 months
- •Pregnant or sexually active female subjects who could possibly become pregnant and who are not willing to use an acceptable form of contraception (barrier method plus one of the following: second barrier, hormonal, IUD, or tubal ligation).
研究组 & 干预措施
Active Neurolumen
The Active Neurolumen group will utilize an active device
干预措施: Active Neurolumen (Device)
Inactive Neurolumen
The Inactive Neurolumen group will utilize an inactive device
干预措施: Inactive Neurolumen (Device)
结局指标
主要结局
Pain Intensity
时间窗: Weeks 1-12
Defense and Veterans Pain Rating Scale. On a scale of 0-10, with higher scores denoting more pain.
Pain Medication Use
时间窗: Weeks 1-12
Opioid Use Diary
次要结局
- Physical Function(Weeks 1-12)
- Sleep Disturbance(Weeks 1-12)