NCT00452010已完成4 期
Pain Reducing Effect of Transcutaneous Electrical Nerve Stimulation (TENS) in Patients With Chronic Low Back Pain or Chronic Lumbo-radiculalgia and Followed in Pain Treatment Centers
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 236
- 试验地点
- 16
- 主要终点
- functional ability
研究概览
简要总结
Prior studies showed contradictory results about the best type of TENS in chronic pain pathology.
Therefore we want to evaluate the efficacy assessment of TENS on patients with chronic low back pain or chronic lumbo-radiculalgia.
The functional ability score is evaluated by the Roland scale at 6 weeks.
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
- Double (Participant, 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
- •Stable chronic low back pain or stable chronic lumbo-radiculalgia
- •Patients with a pain score at least superior or equal to 4
- •Patients followed in pain clinics
- •Written informed consent
排除标准
- •Prior ambulatory TENS practice
- •Lumbo-radiculalgia pathology surgery within 3 months before inclusion
- •Acute low back pain or bilateral lumbo-radiculalgia
- •Acute radiculalgia
- •Surgery planned within 6 months
- •Pacemaker
- •Symptomatic low back pain
研究组 & 干预措施
1
Experimental
transcutaneous electrical nerve stimulation
干预措施: CEFAR PRIMO TENS Class IIA (active) (Device)
2
Placebo Comparator
No transcutaneous electrical nerve stimulation
干预措施: CEFAR PRIMO TENS Class IIA (no active) (Device)
结局指标
主要结局
functional ability
时间窗: Week 6
次要结局
- functional repercussions by Roland scale(Month 3)
- global satisfaction of cares(Month 3)
- medical consumption(From Day 1 to Month 3)
- TENS observance(from Day 1 to Month 3)
- pain relief(Week 6 and Month 3)
- functional repercussions by Dallas scale(Month 3)
- quality of life(Day 1 and Month 3)
研究者
研究点 (16)
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