NCT02161627已完成不适用
Prospective, Multicenter, Randomized Double-blind Crossover Study Examining the Safety and Effectiveness of Spinal Cord Stimulation Incorporating Feedback to Treat Patients With Chronic Pain of the Trunk and/or Limbs in an Extended Trial
Saluda Medical Pty Ltd20 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2014年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 20
- 主要终点
- Percentage of Subjects With Improved Pain Relief and/or Stimulation Side Effects During the Automatic Control Arm Relative to the Manual Control Arm
研究概览
简要总结
The aims of the study are to compare automatic control of spinal cord stimulation with manual control in patients with chronic pain of the trunk and limbs
详细描述
Subjects will use the Saluda Medical External Trial System to compare automatic control of spinal cord stimulation with manual control in a randomized, blinded, crossover study.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Patients enrolled in this study must meet the following inclusion criteria:
- •Have been diagnosed with chronic, intractable pain of the trunk and/or limbs (VAS ≥ 5), which has been refractory to conservative therapy for a minimum of 3 months.
- •Have been approved to undergo a trial of SCS.
- •Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
- •Be on a stable dose (no new, discontinued, or changes in dose) of all prescribed pain medication for at least 4 weeks prior to the trial
- •Be 18 years of age or older at the time of enrollment
- •Be willing and capable of giving informed consent
- •Be willing and able to comply with study-related requirements, procedures, and visits
- •Females of childbearing age must have a negative urine pregnancy test at baseline
排除标准
- •Patients enrolled in this study must not meet the following exclusion criteria:
- •Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
- •Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcomes
- •Are not a surgical candidate due to a diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus
- •Have a diagnosis of scoliosis that precludes lead placement
- •Have a condition, treatable with SCS, that requires leads to be inserted into the cervical region
- •Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker
- •Have a condition currently requiring or likely to require the use of MRI or diathermy
- •Have pain due to a malignant disease
- •Have a life expectancy of less than 1 year
- •Have an active systemic or local infection
- •Be allergic, or have shown hypersensitivity, to any materials of the neurostimulation system which come in contact with the body
- •Be pregnant or nursing (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal)
- •Have within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and/or illicit drugs)
- •Be concomitantly participating in another clinical study
- •Be involved in an injury claim under current litigation
- •Have a pending or approved worker's compensation claim
结局指标
主要结局
Percentage of Subjects With Improved Pain Relief and/or Stimulation Side Effects During the Automatic Control Arm Relative to the Manual Control Arm
时间窗: 20 days
After subjects experience both automatic and manual control after 20 days, subjects are asked to compare pain relief and stimulation side effects between the two arms of the study (blinded) in two separate domains using two 5-point Likert scales. The outcome measure for the primary objective is the percentage of subjects who report improved pain relief with no worsening of stimulation side-effects or improved stimulation side-effects with no loss of pain relief during the automatic control arm relative to the manual control arm. These subjects were considered successful for the primary outcome.
次要结局
- Number of Adverse Events as a Measure of Safety(20 days)
- Compare change from baseline of pain scores between automatic and manual control stimulation(20 days)
- Compare change from baseline of quality of life scores, between automatic and manual control stimulation(20 days)
- Compare patient satisfaction with stimulation as measured on a 5-point Likert scale between automatic and manual control stimulation(20 days)
研究者
研究点 (20)
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