Clinical trial NCT02093793: Safety and Effectiveness Study of the Precision SCS Systems Adapted for High-Rate Spinal Cord Stimulation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Back Pain
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2014-03-21
Enrollment: 383
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Responders as Determined by the Cumulative Distribution Function (CDF) of Response Rates
timeFrame: 3 months post-activation
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Hope Research Institute
state: Arizona
city: Carlsbad
country: United States
facility: Coastal Pain & Spinal Diagnostics
state: California
city: La Jolla
country: United States
facility: UCSD Medical Center - Jacobs Medical Center
state: California
city: San Diego
country: United States
facility: San Diego Pain Institute
state: California
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Shreveport
country: United States
facility: Willis-Knighton River Cities Clinical Research Center
state: Louisiana
city: Edina
country: United States
facility: MAPS Applied Research Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Foundation
state: Minnesota
city: Springfield
country: United States
facility: Mercy Medical Research Institute
state: Missouri
city: Las Vegas
country: United States
facility: Hope Research Institute
state: Nevada
city: Shrewsbury
country: United States
facility: Premier Pain Centers, LLC
state: New Jersey
city: Winston-Salem
country: United States
facility: The Center for Clinical Research, LLC
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Eugene
country: United States
facility: Pacific Sports and Spine, LLC
state: Oregon
city: Eugene
country: United States
facility: Pain Consultants of Oregon
state: Oregon
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Springfield
country: United States
facility: Oregon Neurosurgery
state: Oregon
city: Tyler
country: United States
facility: Precision Spine Care
state: Texas
city: Seattle
country: United States
facility: Pacific Medical Center
state: Washington
Study officials:
affiliation: University of California, San Diego
name: Mark Wallace, M.D.
role: PRINCIPAL_INVESTIGATOR
References: