Fast-Acting Subperception Study (FAST)

Boston Scientific Corporation41 enrolled

Overview

Study to Demonstrate the Value of Fast-Acting Subperception (FAST) using the Spectra WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Pain

Interventions

Boston Scientific Spectra WaveWriter SCS SystemDEVICE

The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain.

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

Key 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 Key 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

Locations (6)

Center for Pain and Supportive Care

Phoenix, Arizona, United States

Willis-Knighton River Cities Clinical Research Center

Shreveport, Louisiana, United States

The Center for Clinical Research, LLC

Winston-Salem, North Carolina, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Overall Pain Responder Rate

Proportion of subjects with 50% or greater reduction from Baseline Visit in average overall pain intensity at 3 months post-randomization

Time frame: 3 months post-randomization

Data from ClinicalTrials.gov

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