The Use of TENS for the Treatment of Back Pain in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain severity
研究概览
简要总结
In this study we will see if application of TENS for a period of 30 minutes in addition to ibuprofen reduces the pain of emergency department patients with back pain compared with ibuprofen and a sham TENS unit.
详细描述
Adult patients presenting to the emergency department with moderate to severe back pain of relatively short duration without neurological deficits will be eligible for inclusion in the study. After signing informed consent the patients will rate their pain severity and receive a 400 mg dose of ibuprofen and then randomly be assigned to either TENS or sham TENS for 30 minutes. At the end of the study period patients will again be asked to rate their pain severity and indicate whether their pain got better or worse. We will also ask them to try and guess which treatment they received and whether they require any medications for their 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Adults age 18 years or greater
- •Able to consent
- •Back pain of less than 2 weeks duration
- •Pain severity of at least 5/10 on a verbal numeric scale from 0 (none) to 10 (worst)
排除标准
- •Pregnant patients
- •Prisoners
- •Neurological deficits
研究组 & 干预措施
TENS
A TENS device consists of an electric pulse generator and pads that are attached to the skin on around the area of maximal pain. We will use the conventional mode, which provides nerve stimulation with a pulse width of 60 microseconds and a pulse rate of 60 pulses per second. The channel intensity will be gradually increased until the intensity is noticeable but not painful.
干预措施: TENS (Device)
SHAM TENS
In the SHAM TENS group the TENS pads will be attached to the pulse generator and the patients skin around the painful area. The investigator will turn the knobs on but the batteries will be removed from the device.
干预措施: SHAM TENS (Device)
结局指标
主要结局
Pain severity
时间窗: 30 minutes after application of TENS unit
Pain severity graded on a verbal numeric pain scales from none (0) to most (10)
次要结局
- Use of rescue medications(30 minutes after application of the TENS unit)
研究者
Adam Singer
Professor and Vice Chairman for Research
Stony Brook University