NCT00290238终止4 期
Percutaneous Neuromodulation Therapy With Chronic Low Back Pain Patients With or Without Lower Extremity Pain - A Randomized, Controlled, Parallel Groups Study
RS Medical16 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2005年12月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 122
- 试验地点
- 16
- 主要终点
- Change From Baseline in Time-averaged Pain Intensity Visual Analog Scale (VAS) Score
研究概览
简要总结
The purpose of this study is to assess the benefits of Percutaneous Neuromodulation Therapy when compared to a reference sham treatment in the treatment of patients who have undergone surgical intervention for chronic low back pain with or without a radiating lower extremity pain component.
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, 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
- •Low back pain for at least 6 months
- •If lower extremity pain present, must be present for at least 3 months
- •Visual analog scale (VAS) score for low back pain at least 50 out of 100
- •Lumbar or lumbosacral surgical intervention without pain relief
- •Central sensitization symptoms
- •Agrees to follow randomized treatment plan
- •18 years of age or older
- •Signed informed consent form
排除标准
- •Significant change to low back or lower extremity pain within 4 weeks prior to enrollment
- •Nociceptive and/or neuropathic pain symptoms in the spine due to structural and/or mechanical instabilities
- •Three or more lumbar or lumbosacral surgical interventions; one or more surgical interventions in areas other than lumbar or lumbosacral spine
- •Three or more lumbar vertebral segments fused
- •Lumbar or lumbosacral surgical intervention in last 9 months; areas other than lumbar or lumbosacral in last 12 months
- •Any additional surgical intervention required 3 months post-enrollment
- •Symptoms consistent with sympathetically-maintained pain
- •Evidence of serious neurological deficits or impairments
- •Significant changes in pain medications within 4 weeks prior to enrollment
- •Psychosocial issues that conflict with valid reporting by patient
- •Prior treatment with percutaneous electrical stimulation or sensitivity to electrical stimulation
- •Current use of another electrical stimulation device for low back or lower extremity pain
- •Current enrollment in another clinical trial within the last 30 days
- •Current or prior malignancy or cancer
- •Serious or uncontrolled systemic illness
- •Body mass index (BMI) greater than 40
- •Pregnant or intends to become pregnant during the study
- •Implanted medical device
- •Relationship with study staff
- •Unable to attend study office visits or complete study measures
结局指标
主要结局
Change From Baseline in Time-averaged Pain Intensity Visual Analog Scale (VAS) Score
时间窗: Time-averaged from the first available observation to the last available observation (12 months for completed subjects)
Visual analog scale (VAS) for pain (100mm line with "0/No pain" on the left and "100/Worst pain imaginable" on the right). Subjects drew vertical line to indicate pain. Time-averaged method accounts for time between visits by dividing area beneath the score curve by time between first and last available visits.
次要结局
- Total Expenditure Per Day on All Lower Back Pain Related Interventions(Baseline, Month 01, Month 02, Month 04, Month 06, Month 08, Month 10, Month 12)
研究者
研究点 (16)
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