Study to Demonstrate the Value of Multiple Modalities and Combining Mechanisms Using the Spectra WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain

Boston Scientific Corporation15 sites in 1 country174 target enrollmentOctober 3, 2018

Overview

Brief Summary

To evaluate the effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities as compared to conventional SCS in patients with chronic pain when using the Boston Scientific Spectra WaveWriter SCS System.

Detailed Description

To evaluate the effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities as compared to conventional SCS in patients with chronic pain when using the Boston Scientific Spectra WaveWriter SCS System.

Registry

clinicaltrials.gov

Start Date

October 3, 2018

End Date

December 15, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boston Scientific Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Chronic pain of the trunk and/or limbs for at least 6 months with back pain greater or equal to leg pain.
•22 years of age or older at time of enrollment
•Able to independently read and complete all questionnaires and assessments provided in English
•Signed a valid, IRB-approved informed consent form (ICF) provided in English

Exclusion Criteria

•Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes
•Significant cognitive impairment that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study
•Breast-feeding or planning to get pregnant during the course of the study or not using adequate contraception
•Participating, or intends to participate, in another clinical trial that may influence the data that will be collected for this study

Outcomes

Primary Outcomes

Overall Pain Responder Rate

Time Frame: 3 months post-randomization

Percentage of subjects with 50% or greater reduction from Baseline Visit in average overall pain intensity at 3 months post-randomization with no increase in opioid medications