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

70 Participants
are divided into 1 treatment group

Locations

7
Colorado
Denver Back Pain Specialists80111, Greenwood United States
Florida
Orlando Health Neuroscience Institute24711, Clermont United States
Louisiana
Ochsner Clinic Foundation70115, New Orleans United States
New York
Montefiore Medical Center10461, The Bronx United States

Sponsors and collaborators

Boston Scientific Corporation

Lead sponsor