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.
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
Age ≥18 y
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)
Single group
MuscleSCS
DeviceThe population for this study will include two specific groups of the same pain population. Group one is the Pre-existing SCS Group, these are pain patients with chronic back pain, and who have been implanted with an SCS system with a percutaneous lead or a paddle lead and BurstDRTM IPG for more than 6 month and having success with their BurstSCS stimulation (\>50% pain relief). Group two is the Trial SCS Group, these are pain patients with chronic back pain, and who have been determined to be candidates for trial and potential permanent SCS with a percutaneous lead or a paddle lead and BurstDRTM IPG.
NRS
Numerical Rating Scale for Pain
ODI
Oswestry Disability Index
EQ5D-5L
5 Dimension Health Related Quality of Life Questionnaire
PDI
Pain Disability Index
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Saint Francis Hospital
Lead sponsor
Abbott Medical Devices
Collaborator
