NL-OMON27344尚未招募不适用
Study Protocol: Multicenter Randomized Clinical Trial to Assess the Effect of Active versus Passive Recharge Burst Spinal Cord Stimulation on Pain Relief in Persistent Spinal Pain Syndrome Type II (the Burst-RAP protocol”, Recharge; Active versus Passive)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 96
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Subject of either gender between 18 and 65 years of age
- •Al least moderate level of catastrophizing as measured with the Pain catastrophizing score (PCS) of at least 20.[23]
- •History consistent with FBSS of at least 6 months
- •Neurologic exam without marked motor deficit.
- •Low Back Pain or leg pain intensity should be 5 or higher measured with the 11-box NRS 0-10
- •Meets all the inclusion criteria for the implantation of a neurostimulation system as typically utilized in the study center. PM: depression is not an exclusion criteria
- •Subject has been screened by a multi-disciplinary panel including a psychologist and deemed suitable for implantation
- •Subject is able and willing to comply with the follow-up schedule and protocol
- •Subject is able to provide written informed consent
排除标准
- •Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study
- •Escalating or changing pain condition within the past month as evidenced by investigator examination
- •Subject has had injection therapy or radiofrequency treatment for their low back pain within the past 3 months
- •Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump
- •Subject is unable to operate the device
- •Severe disc degeneration at the affected level as evidenced by >50% disc height loss on plain anteroposterior and lateral lumbar radiographs or CT/MRI.
- •Moderate to severe spinal stenosis due to osteophyte and/or ligamentous overgrowth as evidenced by MRI or CT in the previous 6 months
- •Moderate to severe endplate degenerative changes at the affected levels
- •Grade 1-2 spondylolisthesis
- •Previous Neurostimulation therapy
研究者
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