A Prospective Evaluation of Spinal Cord Induced Muscle Stimulation (MuscleSCS) for the Treatment of Chronic Low Back Pain
Saint Francis Hospital
Summary
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients with PSPS type 1 and 2 2. Patients with predominant back pain 3. Patient must be willing and able to provide written informed consent before any clinical investigation-related procedure 4. Age ≥18 y 5. 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.) \[GROUP 1\] 6. Low back pain baseline s…
Interventions
- DeviceMuscleSCS
The 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.
Location
- WVUM/Thomas Hospitals (Saint Francis Hospital) Spine and Nerve CenterCharleston, West Virginia