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Fast-Acting Subperception Study (FAST) (FAST)

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ClinicalTrials.gov Identifier: NCT04231409
Recruitment Status : Terminated (Study follow-up activities affected by COVID-19)
First Posted : January 18, 2020
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

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

Condition or disease Intervention/treatment Phase
Chronic Pain Device: Boston Scientific Spectra WaveWriter SCS System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study to Demonstrate the Value of Fast-Acting Subperception (FAST) Using the Spectra WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain (COMBO Study)
Actual Study Start Date : November 26, 2019
Actual Primary Completion Date : October 1, 2020
Actual Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Active Comparator: WaveWriter Settings
WaveWriter Programming
Device: Boston Scientific Spectra WaveWriter SCS System
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.

Active Comparator: Conventional Settings
Conventional Programming
Device: Boston Scientific Spectra WaveWriter SCS System
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.




Primary Outcome Measures :
  1. Overall Pain Responder Rate [ Time Frame: 3 months post-randomization ]
    Proportion of subjects with 50% or greater reduction from Baseline Visit in average overall pain intensity at 3 months post-randomization



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04231409


Locations
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United States, Arizona
Center for Pain and Supportive Care
Phoenix, Arizona, United States, 85028
United States, Louisiana
Willis-Knighton River Cities Clinical Research Center
Shreveport, Louisiana, United States, 71105
United States, North Carolina
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Oregon
Pacific Sports and Spine, LLC
Eugene, Oregon, United States, 97401
United States, Texas
Precision Spine Care
Tyler, Texas, United States, 75701
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Mark Wallace University of California, San Diego
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT04231409    
Other Study ID Numbers: 92285183
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations