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Recruiting NCT07190807

Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control

No phase Interventional Chronic Pain Intractable Pain Low Back Pain Chronic Low-back Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Boston Scientific WaveWriter Alpha™ SCS Systems.
Who it may be relevant to
Registry conditions: Chronic Pain, Intractable Pain, Low Back Pain, Chronic Low-back Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control (MOSAIC Study)

Overview

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.

Interventions

  • Device Boston Scientific WaveWriter Alpha™ SCS Systems
    Time Varied Pulse (TVP)-SCS settings

Primary outcome measures

  • Targeted Pain Responder Rate [Time frame: 3 months post-activation]

Eligibility criteria

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 7 centers
  • Denver Back Pain Specialists — Greenwood
  • Orlando Health Neuroscience Institute — Clermont
  • Ochsner Clinic Foundation — New Orleans
  • Montefiore Medical Center — The Bronx
  • Fox Chase Pain Management — Trevose
  • PCPMG Clinical Research Unit, LLC — Greenville
  • Institute of Precision Pain Medicine — Corpus Christi

Identifiers

NCT: NCT07190807 · A4116

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗