The Effect of 4 Hours of Tens and Heat on Pain and Range of Motion in the Lower Back and the Duration of Pain Relief After Tens and Heat Are Removed
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- pressure on back that causes pain
研究概览
简要总结
Lower back pain is one of the most common and most expensive impairments costing time and expense in the work force today. With the effects on cognitive skills and addictive side effects of opioids and other prescription pain killers, there has been increasing interest in alternative medical treatments to relieve pain. Two of these that are commonly used are heat and transcutaneous electrical nerve stimulation (TENS). In the present investigation, there are two objectives 1) to determine if Tens needs to be continuous or can be intermittent and still achieve pain relief and 2) To see how long pain relief lasts after 4 hours of application of tens, heat or both. There will be seventy-five subjects with chronic back pain divided into 6 groups randomly; 15 subjects per group. The intervention will be either TENS alone, Heat alone or Tens plus heat or a control group.
详细描述
There will be seventy-five subjects with chronic back pain divided into 6 groups randomly; 15 subjects per group. They are between the ages of 24 and 60 years old. They will not be taking pain medications for at least 48 hours prior to the study. The groups were as follows;
- Control
- heat only
- Tens only
- Tens and heat
- Tens for the last 15 minutes each hour plus heat
- Tens for the last 15 minutes each hour Tens is at threshold intensity (12 ma) at a frequency of 20 Hz either ramped continuously or for the last 15 minutes of each hour. The stimulation is 3 seconds increase to threshold, 3 seconds hold and 3 seconds ramped down followed by a 9 second rest period. Pain is assessed by an analog visual pain scale and an algometer placing pressure on the back to assess the pressure that causes pain, a measure of inflammation. In addition, the Oswestry lower back pain index and Roland Morris questionnaire are used. Range of motion in the trunk where first pain is felt is also measured.
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
- None
入排标准
- 年龄范围
- 24 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •pain for at least 3 months in the lower back
- •age range 24-60
排除标准
- •Those with back pain caused by fractures or spinal damage
- •those who had undergone low back surgery within the last year
- •those with diagnosed diabetes
- •no use of opiod pain meds for at least 10 days
研究组 & 干预措施
Tens only
Tens applied for 4 hours with sham heat
干预措施: TENS (Device)
Tens only
Tens applied for 4 hours with sham heat
干预措施: sham heat (Device)
heat only
heat applied to the back for 4 hours with sham TENS
干预措施: Thermacare heat wraps (Device)
heat only
heat applied to the back for 4 hours with sham TENS
干预措施: sham Tens (Device)
control
sham heat and sham TENS
干预措施: sham heat (Device)
control
sham heat and sham TENS
干预措施: sham Tens (Device)
Heat and Tens continuous
Heat and Tens applied together for 4 hours
干预措施: Thermacare heat wraps (Device)
Heat and Tens continuous
Heat and Tens applied together for 4 hours
干预措施: TENS (Device)
Tens 15
Tens applied only 15 minutes each hour for 4 hours, sham heat
干预措施: TENS (Device)
Tens 15
Tens applied only 15 minutes each hour for 4 hours, sham heat
干预措施: sham heat (Device)
Heat and Tens 15
Heat applied for 4 hours with tens only applied the last 15 minutes of each hour
干预措施: Thermacare heat wraps (Device)
Heat and Tens 15
Heat applied for 4 hours with tens only applied the last 15 minutes of each hour
干预措施: TENS (Device)
结局指标
主要结局
pressure on back that causes pain
时间窗: 10 hours after study start( 6 hours after the modality ends)
pressure applied to lower back until pain is felt to assess inflammation
range of motion of the hip for flexion, extension,left and right rotation,left and right bending
时间窗: 10 hours after study start( 6 hours after the modality ends)
range of motion in 6 degrees of freedom in the lower back
subjective pain by marking on scale
时间窗: 10 hours after study start( 6 hours after the modality ends)
analog visual pain scale on separate piece of paper 10cm in length- subject marks pain level with 10 the worst
range of motion of the hip for flexion, extension,left and right rotation,left and right bending
时间窗: Baseline (beginning of study before intervention)
range of motion in 6 degrees of freedom in the lower back
subjective pain by marking on scale
时间窗: Baseline (beginning of study before intervention)
analog visual pain scale on separate piece of paper 10cm in length- subject marks pain level with 10 the worst
pressure on back that causes pain
时间窗: Baseline (beginning of study before intervention)
pressure applied to lower back until pain is felt to assess inflammation
range of motion of the hip for flexion, extension,left and right rotation,left and right bending
时间窗: 4 hours after study start- at end of intervention
range of motion in 6 degrees of freedom in the lower back
subjective pain by marking on scale
时间窗: 4 hours after study start- at end of intervention
analog visual pain scale on separate piece of paper 10cm in length- subject marks pain level with 10 the worst
pressure on back that causes pain
时间窗: 4 hours after study start- at end of intervention
pressure applied to lower back until pain is felt to assess inflammation
次要结局
未报告次要终点