Addressing Feasibility of the DuoTherm in Acute and Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- MMJ Labs LLC
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Pain: Visual Analog Scale (VAS)
研究概览
简要总结
Ten patients with acute or chronic low back pain will be invited to try a multimodal device for 20 minutes. Pain will be recorded prior to and after use, and feedback on the device will be elicited.
详细描述
To facilitate data collection of a short-term intervention, the investigators chose to enroll patients from a mixed physical therapy/chiropractic practice with demographic and economic diversity in the metro Washington area. The neuromodulatory device will have patient controlled frequencies at 50Hz, 100Hz, and 180Hz attached to a 12 x 22 cm metal plate ergonomically curved to fit the low back. The device will be wearable with a neoprene belt on both sides for patients to adjust pressure. The metal pocket in our device holds a 221g clay pack capable of being frozen to 15F or heated to 110F or patient tolerance, with 30 minute thermal capacity. A convenience sample of 10 patients at the clinic was invited to give feedback on the prototype device after informed consent. Changes suggested were incorporated and after informed consent a second group of ten gave will give feedback with the production-ready device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute or chronic low back pain as chief complaint
- •Capacity to understand all relevant risks and potential benefits of the study (informed consent);
- •Willingness to communicate information
排除标准
- •Radicular pain likely reflecting a surgical or mechanical problem
- •BMI greater than 30 (device won't fit)
- •Sensitivity to cold or vibration (e.g Raynaud's or Sickle Cell Disease)
- •Diabetic neuropathy rendering a patient unable to determine if the device is too hot
- •New neurologic deficits
- •Skin lesions over the low back area
- •Contraindication to any medication for pain management that would impact analgesic use record
- •Inability to apply DuoTherm
结局指标
主要结局
Change in Pain: Visual Analog Scale (VAS)
时间窗: Before use of device (baseline) and after use of device approximately 30 minutes - 20 minutes of use, with 10 minutes for evaluation
Difference in 10 cm VAS printed on paper from 0 (no pain) to 10 (most pain) before and after use of the device, higher value indicates a greater pain reduction, 1.8 cm is considered clinically relevant.
Participants' Choice in Thermal Options
时间窗: 30 minutes
One of four options: hot, cold, none, both
Would You Recommend
时间窗: After 30 minutes
Binary approval or disapproval of device
次要结局
- Subjective Pain Relief(30 minutes)
研究者
Amy Lynn Baxter
Principal Investigator
MMJ Labs LLC