NCT07190807NARecruiting
Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control
Boston Scientific Corporation
Start Date
11/7/2025
Completion Date
5/1/2029
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 Criteria
Age Range: 18 years to No maximum
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 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.
Interventions
DEVICE
Boston Scientific WaveWriter Alpha™ SCS Systems
Conditions
Chronic PainIntractable PainLow Back PainChronic Low-back PainChronic Leg PainLeg Pain
Locations
Denver Back Pain Specialists
Greenwood, Colorado 80111
United States
Orlando Health Neuroscience Institute
Clermont, Florida 24711
United States
Ochsner Clinic Foundation
New Orleans, Louisiana 70115
United States
Montefiore Medical Center
The Bronx, New York 10461
United States
Fox Chase Pain Management
Trevose, Pennsylvania 19053
United States
PCPMG Clinical Research Unit, LLC
Greenville, South Carolina 29601
United States
Institute of Precision Pain Medicine
Corpus Christi, Texas 78414
United States