Ashwin Viswanathan
The goal of this study is to compare pain outcomes achieved by spinal cord stimulation (SCS) using time varying stimulation patterns with pain outcomes achieved by current standard of care SCS.
The researchers will conduct a traditional exploratory feasibility study using an investigational device to compare the clinical outcomes using time varying pulse (TVP) waveforms against time-invariant pulse (TIP) waveforms using both paresthesia and paresthesia-free SCS therapies. The therapy longevity of TVPs and TIPS will also be evaluated by tracking therapy efficacy through a long-term follow-up phase, using multiple pain assessments and at-home digital data collection.
Inclusion Criteria: * Ability to provide informed consent * Age ≥ 22 * Chronic pain of the trunk and/or limbs for at least 6 months * Baseline average daily overall pain score of \>60 (on a scale of 0-100mm) on the Visual Analog Scale related to pain of the back and/or limbs * Failed ≥3 medically supervised treatments (i.e. pain medications, physical therapy, facet joint/medial branch nerve blocks, acupuncture), and treatment with \>2 classes of medications * Stable pain-related medication regimen 4 weeks prior to the trial. Patients will be asked to not increase or add pain-related medicatio…
Spinal Cord Stimulator modified to deliver Time Variant Pulse (TVP) stimulation.
Spinal Cord Stimulator to deliver standard of care Time Invariant Pulse (TIP) stimulation.
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