Chronic PainIntractable PainLow Back PainChronic Low-back PainChronic Leg PainLeg Pain
Investigational drug(s) / intervention(s)
Boston Scientific WaveWriter Alpha™ SCS Systems
Boston Scientific WaveWriter Alpha™ SCS Systems: Time Varied Pulse (TVP)-SCS settings
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Targeted Pain Responder Rate — 3 months post-activation Proportion of subjects with 50% or greater reduction from Baseline Visit in average targeted pain intensity at 3 months post-activation
Trial sites (7)
Facility
City
Region
Status
Denver Back Pain Specialists
Greenwood
Colorado
Recruiting
Orlando Health Neuroscience Institute
Clermont
Florida
Recruiting
Ochsner Clinic Foundation
New Orleans
Louisiana
Recruiting
Montefiore Medical Center
The Bronx
New York
Recruiting
Fox Chase Pain Management
Trevose
Pennsylvania
Recruiting
PCPMG Clinical Research Unit, LLC
Greenville
South Carolina
Recruiting
Institute of Precision Pain Medicine
Corpus Christi
Texas
Recruiting
More Boston Scientific Corporation trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.