Fast-Acting Subperception Study (FAST)

Chronic Pain Clinical Trial

— FAST  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04231409
• Other study ID #: 92285183
• Status: Terminated
• Phase: N/A
• Start date: November 26, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: January 2022
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Pacific Sports and Spine, LLC	Eugene	Oregon
United States	Center for Pain and Supportive Care	Phoenix	Arizona
United States	Willis-Knighton River Cities Clinical Research Center	Shreveport	Louisiana
United States	Precision Spine Care	Tyler	Texas
United States	The Center for Clinical Research, LLC	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months post-randomization