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

Chronic Pain Clinical Trial

— ACCELERATE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02093793
• Other study ID #: A4007
• Status: Completed
• Phase: N/A
• Start date: March 27, 2014
• Est. completion date: August 29, 2019

Study information

• Verified date: November 2020
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 383
• Est. completion date: August 29, 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain

Intervention

Device:
• PRECISION SCS Adapted for High-Rate SCS
Comparison of spinal cord stimulation parameters

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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