NCT05837234进行中（未招募）不适用
A Prospective, Open-Label, Multi-Center Trial to Evaluate the Safety and Effectiveness of Ultra Low Frequency Spinal Cord Stimulation in Patients With Chronic Low Back Pain
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 55
- 试验地点
- 6
- 主要终点
- Back pain responder rate at 3 months as assessed using a visual analog scale (VAS)
研究概览
简要总结
The Presidio Medical Ultra Low Frequency (ULF™) Spinal Cord Stimulation (SCS) System is intended to provide pain relief to participants who have been clinically diagnosed with chronic low back pain with or without leg pain.
详细描述
This is a prospective, open-label, multi-center clinical trial in which participants with chronic low back pain (CLBP) with/without leg pain will be invited to enroll and undergo treatment with the ULF SCS system. The purpose of this study is to evaluate the safety and effectiveness of ULF SCS over a 3-year period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosed with chronic low back pain with/without leg pain (VAS ≥60mm for back pain for the past week), which has been refractory to conservative therapy for a minimum of 3 months.
- •Be on no or stable pain medications, as determined by the investigator, for at least 28 days prior to the screening visit.
- •Is currently considered medically stable as judged by investigator.
- •Able to operate the SCS device (e.g., using remote control) and charge the device appropriately.
- •Determined to be a good surgical candidate by the investigator.
- •Willing to sign the Human Research Ethics Committee (HREC) approved informed consent and deemed capable of complying with the requirements of the study protocol.
- •Willing to stay on stable medications until implantable pulse generator (IPG) activation (i.e., from IPG implant to IPG activation, except for usual postoperative medications required following IPG insertion).
- •Able to comply with study requirements and attend all scheduled visits.
- •Eighteen (18) years of age or older.
- •Literate, able to speak English and able to complete questionnaires independently.
排除标准
- •Diagnosis of active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance, intervention and/or ability to evaluate treatment outcome as assessed by a clinical psychologist or psychiatrist in a psychological assessment performed at Baseline.
- •Chronic pain in any area other than back or legs, such that it precludes subject's ability to assess their pain for the primary indication of chronic low back pain as determined by Investigator.
- •Previous experience with implantable neuromodulation devices (e.g., spinal cord stimulation, peripheral nerve stimulation, dorsal root ganglion stimulation).
- •Opioid usage with average total daily morphine equivalent dose (MED) of >60 mg.
- •A known need for an MRI or surgery within a 2-week period of the screening visit through the end of the study.
- •Female candidates of childbearing potential that are pregnant (confirmed by positive urine/blood pregnancy test) or plan to get pregnant during the duration of the study.
- •Subject is participating in another interventional clinical trial.
结局指标
主要结局
Back pain responder rate at 3 months as assessed using a visual analog scale (VAS)
时间窗: 3 months
A responder is defined as a participant that achieved at least 50% reduction in back pain at the follow-up compared to baseline. Responder rate is defined as the percentage of participants that were responders.
次要结局
- Change in leg pain VAS at 3 months(3 months)
- Change in back pain VAS at 12 months(12 months)
- Proportion of participants with a MCID as measured by ODI at 6 months(6 months)
- Proportion of participants with a minimal clinically important difference (MCID) as measured by Oswestry Disability Index (ODI) at 3 months(3 months)
- Proportion of participants with a MCID as measured by ODI at 12 months(12 months)
- Change in EQ-5D quality of life index at 6 months(6 months)
- Change in EQ-5D quality of life index at 12 months(12 months)
- Change in sleep quality as assessed by MOS-SS at 12 months(12 months)
- Change in back pain VAS at 3 months(3 months)
- Change in leg pain VAS at 12 months(12 months)
- Change in EuroQol-5 Dimension (EQ-5D) quality of life index at 3 months(3 months)
- Proportion of participants with remission of low back pain as assessed by VAS at 6 months(6 months)
- Change in back pain VAS at 6 months(6 months)
- Change in leg pain VAS at 6 months(6 months)
- Proportion of participants with remission of low back pain as assessed by VAS at 9 months(9 months)
- Change in sleep quality as assessed by MOS-SS at 6 months(6 months)
- Proportion of participants with remission of low back pain as assessed by VAS at 12 months(12 months)
- Change in sleep quality as assessed by Medical Outcomes Study Sleep Scale (MOS-SS) at 3 months(3 months)
研究者
研究点 (6)
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