Overview

This trial is active, not recruiting.

Conditions chronic pain, back pain
Treatment precision scs adapted for high-rate scs
Phase phase 3
Sponsor Boston Scientific Corporation
Start date March 2014
End date May 2016
Trial size 406 participants
Trial identifier NCT02093793, A4007

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
PRECISION SCS Adapted for High-Rate SCS
precision scs adapted for high-rate scs Boston Scientific PRECISION Spinal Cord Stimulator System
Comparison of spinal cord stimulation parameters
(Active Comparator)
PRECISION SCS Adapted for High-Rate SCS
precision scs adapted for high-rate scs Boston Scientific PRECISION Spinal Cord Stimulator System
Comparison of spinal cord stimulation parameters

Primary Outcomes

Measure
Low back pain responder rate from Baseline
time frame: 3 months post-activation

Eligibility Criteria

Male or female participants at least 22 years old.

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

Additional Information

Official title A Randomized Controlled Study to Evaluate the Safety and Effectiveness of the Precision Spinal Cord Stimulator System Adapted for High-Rate Spinal Cord Stimulation
Principal investigator Mark Wallace, M.D.
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 System Adapted for High-Rate Spinal Cord Stimulation (PRECISION SCS System for HR)
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Boston Scientific Corporation.