A Prospective Evaluation of Spinal Cord Induced Muscle Stimulation (MuscleSCS) for the Treatment of Chronic Low Back Pain

Saint Francis Hospital1 个研究点分布在 1 个国家目标入组 30 人开始时间: 2025年10月7日最近更新: 2025年10月10日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方
入组人数: 30
试验地点: 1
主要终点: NRS

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is a prospective, multi-center study designed to compare the safety and efficacy of spinal cord induced muscle stimulation (MuscleSCS) for the treatment of chronic low back pain.

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

•Patients with PSPS type 1 and 2
•Patients with predominant back pain
•Patient must be willing and able to provide written informed consent before any clinical investigation-related procedure
•Patients with SCS(BurstDR) stimulation in situ for more than 6 month and >50% pain relief. Patients have to be satisfied with their existing SCS therapy and predominantly use a BurstDR stimulation program.
•(Only responders to that therapy should be included, not patients who have not responded to their therapy so far.) [GROUP 1]
•Low back pain baseline score of ≥6 on NRS before spinal cord stimulation therapy and a MCID (Minimal clinically important difference) of >50% with SCS(BurstDRTM) trial stimulation. [GROUP 2]
•Willing and able to comply with the instructions for use, operate the study device, and comply with this clinical investigation plan

排除标准

•Pathology seen on imaging tests obtained within the past 12 month that is clearly identified and is likely the cause of the CLBP, that can be addressed with surgery
•Primary symptom of leg pain, or leg pain is greater than back pain
•Back pain is due to any of the following: vascular causes (eg, aortic aneurysm), spinal infection (eg, osteomyelitis), inflammation or damage to the spinal cord (eg, arachnoiditis or syringomyelia), tumor or spinal metastases
•Has widespread pain (eg, fibromyalgia) or pain in other area(s), not intended to be treated in this study (eg, neck pain, shoulder pain)
•Patient has used a morphine equivalent daily dose of >50 MME in the last 30 days
•Patients with regular intake of systemic steroids (except inhaled steroids used to treat asthma)
•Imaging (MRI, CT, x-ray) findings within the last 12 mon that contraindicate lead placement
•Known allergic reaction to implanted materials
•Severe scoliotic deformity (>11◦ in thoracic or lumbar spine)
•Patient has a history of or existing intrathecal drug pump
•Patient with other existing implantable electrical devices, i.e. pacemakers, bladder stimulators, etc.
•Patient has previous experience with neuromodulation devices, including a failed trial
•Patient is enrolled, or intends to participate, in another clinical drug and/or device study or registry that may interfere with the results of this study.
•Presence of other anatomic or comorbid conditions, or other medical, social, or psychologic conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results
•Failed psychologic evaluation
•Suspicion or evidence of untreated mental illness, substance abuse, or drug-seeking behavior
•Patient is in current litigation for back pain/injury, or is currently receiving worker's compensation
•Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.