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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

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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