Safety and Effectiveness Study of the Precision SCS Systems Adapted for High-Rate Spinal Cord Stimulation

Not Applicable

Completed

Brief Summary: To evaluate the safety and effectiveness of the Precision Spinal Cord Stimulator Systems Adapted for High-Rate Spinal Cord Stimulation as an aid in the management of chronic intractable pain

Detailed Description: To evaluate the safety and effectiveness of high rate spinal cord stimulation (HR-SCS) therapy as an aid in the management of chronic intractable pain of the trunk using the Boston Scientific (BSC) PRECISION Spinal Cord Stimulator Systems Adapted for High-Rate Spinal Cord Stimulation

Recruitment & Eligibility

Inclusion Criteria

Have been diagnosed with chronic, intractable pain of the trunk (NRS ≥ 5) which has been refractory to conservative therapy for a minimum of 90 days.
Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
Be 22 years of age or older at the time of enrollment
Be willing and capable of giving informed consent
Be willing and able to comply with study-related requirements, procedures, and visits

Exclusion Criteria

Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome, as determined by a psychologist
Have previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
Have a current systemic infection, or local infection in close proximity to anticipated surgical field
Pregnant or plan to get pregnant during the course of the study or not using adequate contraception.
Be participating in another clinical study that may influence the data collected for the study

Arm && Interventions

Group	Intervention	Description
High Rate Spinal Cord Stimulation	PRECISION SCS Adapted for High-Rate SCS	PRECISION SCS Adapted for High-Rate SCS
Commercial Rate Spinal Cord Stimulation	PRECISION SCS Adapted for High-Rate SCS	PRECISION SCS Adapted for High-Rate SCS

Primary Outcome Measures

Name	Time	Method
Proportion of Responders as Determined by the Cumulative Distribution Function (CDF) of Response Rates	3 months post-activation	Cummulative distribution function (CDF) of response rates from 0% - 100% numerical rating score (NRS) to derive the entire range of possible responder definitions. This allows us to determine the range of success for all responder rates without the need to identify a certain cutoff (for example, use a 50% responder rate). A comparison between the two CDF's was performed by comparing the area under the curves since area between CDFs is equal to the mean difference in low back pain reduction for CR-SCS and HR-SCS. Hence, it can be used to estimate the true underlying difference in responder rates between CR-SCS and HR-SCS

Secondary Outcome Measures

Name	Time	Method

Locations (19): Coastal Pain & Spinal Diagnostics
🇺🇸
Carlsbad, California, United States
UCSD Medical Center - Jacobs Medical Center
🇺🇸
La Jolla, California, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
Compass Research, LLC
🇺🇸
Orlando, Florida, United States
Premier Pain Centers, LLC
🇺🇸
Shrewsbury, New Jersey, United States
MAPS Applied Research Center
🇺🇸
Edina, Minnesota, United States
The Center for Clinical Research, LLC
🇺🇸
Winston-Salem, North Carolina, United States
Pacific Sports and Spine, LLC
🇺🇸
Eugene, Oregon, United States
Oregon Neurosurgery
🇺🇸
Springfield, Oregon, United States
Precision Spine Care
🇺🇸
Tyler, Texas, United States
Pacific Medical Center
🇺🇸
Seattle, Washington, United States
Pain Consultants of Oregon
🇺🇸
Eugene, Oregon, United States
University Hospitals of Cleveland
🇺🇸
Cleveland, Ohio, United States
Willis-Knighton River Cities Clinical Research Center
🇺🇸
Shreveport, Louisiana, United States
Hope Research Institute
🇺🇸
Las Vegas, Nevada, United States
San Diego Pain Institute
🇺🇸
San Diego, California, United States
Mayo Clinic Foundation
🇺🇸
Rochester, Minnesota, United States
Oregon Health Sciences University
🇺🇸
Portland, Oregon, United States
Mercy Medical Research Institute
🇺🇸
Springfield, Missouri, United States