About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- MuscleSCS
Treatment groups
Sponsors and collaborators
Saint Francis Hospital
Lead sponsor
Abbott Medical Devices
Collaborator