PRECISION SCS Adapted for High-Rate SCS
DeviceComparison of spinal cord stimulation parameters
Other names: Boston Scientific PRECISION Spinal Cord Stimulator System
NCT Number: NCT02093793
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
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Notify Me22 year and older
All sexes
Interventional
Not applicable
Hope Research Institute, Phoenix, Arizona, United States
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Comparison of spinal cord stimulation parameters
Other names: Boston Scientific PRECISION Spinal Cord Stimulator System
Time frame: 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
Boston Scientific Corporation
Industry
A Randomized Controlled Study to Evaluate the Safety and Effectiveness of the Precision Spinal Cord Stimulator Systems Adapted for High-Rate Spinal Cord Stimulation
Acronym: ACCELERATE
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