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

Study Overview
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Brief Summary
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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
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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

Official Title
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A Randomized Controlled Study to Evaluate the Safety and Effectiveness of the Precision Spinal Cord Stimulator Systems Adapted for High-Rate Spinal Cord Stimulation

Conditions
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Chronic Pain, Back Pain

Intervention / Treatment
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* Device: PRECISION SCS Adapted for High-Rate SCS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Rate Spinal Cord Stimulation<br>PRECISION SCS Adapted for High-Rate SCS | Device: PRECISION SCS Adapted for High-Rate SCS<br>* Comparison of spinal cord stimulation parameters<br>* Other names: Boston Scientific PRECISION Spinal Cord Stimulator System;|
| Active Comparator: Commercial Rate Spinal Cord Stimulation<br>PRECISION SCS Adapted for High-Rate SCS | Device: PRECISION SCS Adapted for High-Rate SCS<br>* Comparison of spinal cord stimulation parameters<br>* Other names: Boston Scientific PRECISION Spinal Cord Stimulator System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Responders as Determined by the Cumulative Distribution Function (CDF) of Response Rates | 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 | 3 months post-activation |