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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSaint Francis Hospital

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

No treatment groups listed

Sponsors and collaborators

Saint Francis Hospital

Lead sponsor

Abbott Medical Devices

Collaborator