About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Any pain-related diagnosis, medical or psychological condition that, in the Investigator's judgment might confound reporting of study outcomes (e.g., vascular or neurogenic claudication, osteoarthritis, plantar fasciitis, pelvic pain, anginal pain, chronic migraine, acute herniated disc, malignancy, untreated major depression, injury claim).
Significant cognitive impairment at Screening and Baseline visit that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study
A female who is pregnant, lactating, or is of childbearing potential and planning to get pregnant during the study or not using adequate contraception.
Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study.
Trial design
Treatments tested in this trial
- Boston Scientific WaveWriter Alpha™ SCS Systems
Treatment groups
Locations
7Sponsors and collaborators
Boston Scientific Corporation
Lead sponsor