Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control (MOSAIC Study)
Boston Scientific Corporation
Summary
Study to evaluate the effectiveness of time variant pulse (TVP)-SCS in patients with chronic pain using commercially approved Boston Scientific SCS Systems per local Instructions for use (IFU). In addition, to compile real-world clinical outcomes in subjects with chronic, intractable low back and/or leg pain.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Persistent spinal pain syndrome (PSPS) Type I (or non-surgical refractory back pain), or PSPS Type II (Failed Back Surgery Syndrome, FBSS) diagnosis. * Diagnosed with chronic pain of the trunk and/or limbs for at least 6 months. * 18 years of age or older when written informed consent is obtained * Able to independently read and complete all questionnaires and assessments provided in English. * Signed a valid, IRB or EC approved informed consent form (ICF) provided in English. Key Exclusion Criteria: * Any pain-related diagnosis, medical or psychological condition…
Interventions
- DeviceBoston Scientific WaveWriter Alpha™ SCS Systems
Time Varied Pulse (TVP)-SCS settings
Locations (7)
- Denver Back Pain SpecialistsGreenwood, Colorado
- Orlando Health Neuroscience InstituteClermont, Florida
- Ochsner Clinic FoundationNew Orleans, Louisiana
- Montefiore Medical CenterThe Bronx, New York
- Fox Chase Pain ManagementTrevose, Pennsylvania
- PCPMG Clinical Research Unit, LLCGreenville, South Carolina