NCT02346656终止不适用
BRAVO: a BavaRiAn eValuatiOn of DRG Stimulation for the Treatment for Chronic Post Surgical Pain of the Groin
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Pain Relief - Assessed by Change in Pain Intensity Assessed using a Visual Analogue Scale (VAS) from Pre-Treatment Baseline
研究概览
简要总结
15-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of chronic post surgical groin pain
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •The patient is at least 18 years old
- •The patient is willing and able to comply with the examination schedule and the trial schedule.
- •The patient has suffered from chronic post-surgical neuropathic groin pain for at least 6 months
- •Conservative treatments of the chronic pain including medication, physiotherapy and interventions have been exhausted
- •The pain level at the time of the baseline examination is at least 60mm on the visual analogue scale (VAS) in the primary pain area (groin pain)
- •The patient is able to give consent in writing
排除标准
- •Pregnant or breastfeeding patients or those who plan to become pregnant during the study
- •It has been established in an examination by the tester that the pain has significantly worsened or changed its characteristics in the course of the previous month.
- •In the last 30 days, the patient has been treated with corticosteroids on an area scheduled for the stimulation.
- •In the last 3 months, the patient has been treated with radio frequency therapy on an area scheduled for the stimulation.
- •The patient has already been treated with an active implantable device, including an implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or an intrathecal medication pump.
- •The patient is not able to operate the stimulation device
- •The patient is currently suffering from an infection
- •The patient has participated in another clinical study in the last 30 days
- •The patient has a coagulation disorder or is taking anti-coagulants, which would make participation impossible, as per the study doctor
- •The patient has been diagnosed with a malignancy in the past 2 years
结局指标
主要结局
Pain Relief - Assessed by Change in Pain Intensity Assessed using a Visual Analogue Scale (VAS) from Pre-Treatment Baseline
时间窗: Post treatment at; 1 week and 1, 3, 6 and12 months
次要结局
未报告次要终点
研究者
研究点 (1)
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