Time‑variant pulse spinal cord stimulation for chronic low back and leg pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study uses commercially approved Boston Scientific WaveWriter Alpha spinal cord stimulation systems, delivered per local instructions for use, to apply a time‑variant pulse (TVP) waveform in patients with chronic trunk and/or limb pain. Eligible adults have persistent spinal pain syndrome (PSPS) Type I or II or non‑surgical refractory back pain and symptoms for at least six months. The study will collect real‑world clinical outcomes and patient‑reported measures at participating sites to characterize pain response to TVP‑SCS. Enrollment and follow‑up involve in‑clinic visits at designated U.S. centers and completion of English questionnaires.

Why it matters

Who can join: the full rules

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.

Where it's running

• Denver Back Pain Specialists
  Greenwood, Colorado, United States Recruiting
• Orlando Health Neuroscience Institute
  Clermont, Florida, United States Recruiting
• Ochsner Clinic Foundation
  New Orleans, Louisiana, United States Recruiting
• Montefiore Medical Center
  The Bronx, New York, United States Recruiting
• Fox Chase Pain Management
  Trevose, Pennsylvania, United States Recruiting
• PCPMG Clinical Research Unit, LLC
  Greenville, South Carolina, United States Recruiting

Study contacts

• Study coordinator: Thanh Hoang
• Email: BSNClinicalTrials@bsci.com
• Phone: 855-213-9890

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.