ACTRN12620000939998已完成未知
A Randomized, Controlled, Multi-Center, Non-Inferiority Trial to Evaluate the Safety and Efficacy of Ultra-Low Frequency Spinal Cord Stimulation Compared to Traditional Spinal Cord Stimulation in Subjects with Chronic Back Pain with/without Leg Pain
Presidio Medical AU, Pty Ltd0 个研究点目标入组 91 人开始时间: 2020年9月21日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 91
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Eighteen (18) years of age or older
- •2.Literate, able to speak English and able to complete questionnaires independently
- •3.Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol
- •4.Have been diagnosed with chronic low back pain with/without associated leg pain (VAS greater than 50mm for the past week), which has been refractory to conservative therapy for a minimum of 3 months
- •5.Are currently receiving optimal medical management and considered medically stable as judged by investigator
- •6.Ability to independently change AA batteries and operate EPG.
- •7.Able to comply with study requirements and attend all scheduled visits
排除标准
- •1.If female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least two years post-menopausal
- •2.Severe cognitive impairment as determined by Investigator
- •3.A psychological assessment will be performed at Baseline to exclude 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 outcome. This will be performed by a clinical psychologist/ psychiatrist
- •4.Pre-existing motor, balance, proprioception, or sensory deficits as determined by investigator
- •5.Spinal stenosis or other structural spinal abnormality observed on MRI that would make lead placement unsafe or untowardly difficult as determined by investigator
- •6.Average total daily morphine equivalent dose (MED) of greater than 100 mg
- •7.Currently taking anticoagulants including Warfarin, Heparin, Low Molecular Weight Heparin, Factor Xa inhibitors, GPIIb/IIIa inhibitors, thienopyridine inhibitors, direct thrombin inhibitors, or any other anticoagulant that is a contraindication to epidural lead placement within 1 week of the Screening Visit
- •8.Current coagulopathy, thrombocytopenia or bleeding diathesis (confirmed by clinical history and, if clinically indicated, by coagulation screening)
- •9.Cardiac demand pacemaker, implanted defibrillator or another implanted electronic device
- •10.A systemic condition or disease not stabilized or judged by the investigator to be incompatible with participation in the study (e.g. current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction, etc.)
- •11.Known hypersensitivity to any of the procedural agents or materials in the study device that is inserted into the subject
- •12.Previous use of spinal cord stimulation or comparable therapy
- •13.For subjects with diagnosed diabetes, a Hemoglobin A1C (HgB A1C) level that is greater than (greater than) 8.55%
- •14.Body Mass Index (BMI) score that is greater than 40
- •15.Diagnosis of Fibromyalgia
- •16.VAS of greater than 30mm in any area other than back or legs
- •17.A known need for an MRI or surgery within a 2-week period of the screening visit.
- •18.Any experimental drug or device used within 30 days prior to the Screening Visit or during the course of the clinical trial
- •19.No access to a computer or mobile device
- •20.Subjects who are involved in ongoing or closed litigation related to their pain condition
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