NCT01550562终止不适用
Precision™ High-Rate Sub-perception Spinal Cord Stimulation for the Treatment of Chronic Intractable Pain
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Pain Relief
研究概览
简要总结
The purpose of this study is to investigate the effects of varying programming parameters in subthreshold spinal cord stimulation therapy for pain relief.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Chronic intractable pain of the trunk and/or limbs
- •Documented history of trunk and/or limb pain of at least 180 days
- •Average back pain intensity of 5 or greater on a 0-10 numerical rating scale during the 7-day period prior to the Screening Visit
- •Pass study site's routine psychological/psychiatric evaluation within 180 days of the Trial Lead Insertion Visit
- •If taking any medications for chronic pain, must be on a stable prescription during the 14-day period prior to the Trial Lead Insertion Visit and agree to continue on the same prescription throughout study participation
- •Subject is willing and able to comply with all protocol-required procedures and assessments/evaluations
- •Subject is able to independently read and complete all questionnaires and/or assessments provided in English
- •18 years of age or older when written informed consent is obtained
- •Subject signs a valid, Ethics Committee-approved informed consent form (ICF) provided in English
排除标准
- •Unable to operate the PrecisionPlus™ system
- •Primary source of pain is cancer-related, pelvic, visceral, angina, or migraine
- •Is a high surgical risk
- •Is diabetic
- •Is immunocompromised
- •Currently on any anticoagulant medications that cannot be discontinued during perioperative period
- •Untreated major depression or untreated generalized anxiety disorder
- •Diagnosed with somatoform disorder, severe personality disorder, borderline personality disorder
- •Diagnosed with any major psychiatric disorder not specifically listed in previous two exclusion criterion
- •Currently diagnosed with cognitive impairment that would limit subject's ability to discern differences in pain severity, complete a pain diary, perform wound care
- •Current abuse of alcohol or illicit drugs
- •Subject requires Magnetic Resonance Imaging (MRI) while implanted with lead(s).
- •Subject is participating (or intends to participate) in another investigational drug or device clinical trial that may influence the data that will be collected for this study
- •Subject has previously undergone a spinal cord stimulation trial or is already implanted with an active implantable device(s) to treat their pain (IPGs, implantable drug pump, etc) or pacemaker or implantable cardiac defibrillator
- •Patient is a woman who is not using adequate contraception, is pregnant or breastfeeding or intends to become pregnant during the course of the study (a urine pregnancy test must be performed within 28 days prior to the Trial Lead Insertion Visit in women of child-bearing potential and the test result document)
结局指标
主要结局
Pain Relief
时间窗: 4,8,and 12 days post temporary lead(s) implantation
Mean within-patient difference in average back pain intensity among treatment groups
次要结局
- Pain Relief Responder Rate(4,8,and 12 days post temporary lead(s) implantation)
- Leg Pain Reduction(4,8,and 12 days post temporary lead(s) implantation)
- Quality of Life, as Measured by EQ-5D-5L(4,8,and 12 days post temporary lead(s) implantation)
- Percent Pain Relief(4,8,and 12 days post temporary lead(s) implantation)
- Disability(4,8,and 12 days post temporary lead(s) implantation)
研究者
研究点 (2)
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