Overview

This trial has been terminated.

Condition chronic pain
Treatments conventional single source programming, precision spectra scs system advanced programming
Sponsor Boston Scientific Corporation
Start date February 2015
End date October 2016
Trial size 19 participants
Trial identifier NCT02384096, 90968587

Summary

The study is a prospective, on-label, multi-center, blinded, randomized controlled trial with a cross-over design to evaluate the effect of Precision Spectra™ SCS System's programming features and lead options.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (subject)
Arm
(Active Comparator)
Precision Spectra SCS System with CoverEdge Surgical Lead. Subjects will be randomized to receive conventional single source programming followed by Precision Spectra SCS System advanced programming or Precision Spectra SCS System advanced programming followed by conventional single source programming.
conventional single source programming
Precision Spectra SCS System using conventional single source programming.
precision spectra scs system advanced programming
Precision Spectra SCS System using advanced programming
(Active Comparator)
Precision Spectra SCS System with more than 2 percutaneous leads. Subjects will be randomized to receive conventional single source programming followed by Precision Spectra SCS System advanced programming or Precision Spectra SCS System advanced programming followed by conventional single source programming.
conventional single source programming
Precision Spectra SCS System using conventional single source programming.
precision spectra scs system advanced programming
Precision Spectra SCS System using advanced programming

Primary Outcomes

Measure
Change in percent paresthesia coverage of targeted pain while minimizing unwanted paresthesia
time frame: 7, 14 days post activation

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Meets RELIEF Registry criteria for inclusion - Primary complaint of persistent or recurrent low back pain, with or without leg pain - Signed a valid, IRB/EC-approved informed consent form Exclusion Criteria: - Meets any RELIEF Registry criteria for exclusion

Additional Information

Official title COVERAGE - A Study to Evaluate the Effect of Precision Spectra™ SCS System's Programming Features and Lead Options on Patient Outcomes
Description The study is a sub-study of RELIEF - A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain. The treatment will consist of permanent implant of a Precision Spectra™ SCS IPG with either a 32 contact CoverEdge™ Surgical Lead or with more than 2 percutaneous leads after a successful trial. Programming features and lead options of the Precision Spectra™ SCS System will be evaluated up to 3 months post-IPG activation. Following completion of the 3 month visit, subjects will continue to be followed for up to 36 months per the study requirements of the RELIEF Registry.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Boston Scientific Corporation.