Fast-Acting Subperception Study (FAST)
Study Details
Study Description
Brief Summary
Study to Demonstrate the Value of Fast-Acting Subperception (FAST) using the Spectra WaveWriterâ„¢ Spinal Cord Stimulator System in the Treatment of Chronic Pain
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
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.
|
Outcome Measures
Primary Outcome Measures
- Overall Pain Responder Rate [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
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Center for Pain and Supportive Care | Phoenix | Arizona | United States | 85028 |
2 | Willis-Knighton River Cities Clinical Research Center | Shreveport | Louisiana | United States | 71105 |
3 | The Center for Clinical Research, LLC | Winston-Salem | North Carolina | United States | 27103 |
4 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
5 | Pacific Sports and Spine, LLC | Eugene | Oregon | United States | 97401 |
6 | Precision Spine Care | Tyler | Texas | United States | 75701 |
Sponsors and Collaborators
- Boston Scientific Corporation
Investigators
- Principal Investigator: Mark Wallace, University of California, San Diego
Study Documents (Full-Text)
More Information
Publications
None provided.- 92285183
Study Results
Participant Flow
Recruitment Details | After subjects were enrolled, they were evaluated per study eligibility criteria. Only those who met all criteria proceeded to receive implant and randomized in the study (as applicable). |
---|---|
Pre-assignment Detail |
Arm/Group Title | WaveWriter Settings | Conventional Settings |
---|---|---|
Arm/Group Description | WaveWriter Programming 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. | Conventional Programming 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. |
Period Title: Overall Study | ||
STARTED | 5 | 4 |
COMPLETED | 0 | 0 |
NOT COMPLETED | 5 | 4 |
Baseline Characteristics
Arm/Group Title | WaveWriter Settings | Conventional Settings | Total |
---|---|---|---|
Arm/Group Description | WaveWriter Programming 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. | Conventional Programming 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. | Total of all reporting groups |
Overall Participants | 5 | 4 | 9 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
59.2
(16.5)
|
57.3
(7.3)
|
58.3
(12.5)
|
Sex: Female, Male (Count of Participants) | |||
Female |
3
60%
|
2
50%
|
5
55.6%
|
Male |
2
40%
|
2
50%
|
4
44.4%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
1
25%
|
1
11.1%
|
Asian |
0
0%
|
0
0%
|
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
Black or African American |
0
0%
|
0
0%
|
0
0%
|
White |
5
100%
|
3
75%
|
8
88.9%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Overall Pain Score (units on a scale) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [units on a scale] |
7.6
(0.9)
|
7.3
(1.0)
|
7.4
(0.9)
|
Outcome Measures
Title | Overall Pain Responder Rate |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Data not collected and hence not available due to termination of the study (Follow-up activities affected by COVID-19) |
Arm/Group Title | WaveWriter Settings | Conventional Settings |
---|---|---|
Arm/Group Description | WaveWriter Programming 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. | Conventional Programming 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. |
Measure Participants | 0 | 0 |
Adverse Events
Time Frame | Adverse events up to end of randomized phase (3 months) | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | WaveWriter Settings | Conventional Settings | ||
Arm/Group Description | WaveWriter Programming 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. | Conventional Programming 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. | ||
All Cause Mortality |
||||
WaveWriter Settings | Conventional Settings | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/5 (0%) | 0/4 (0%) | ||
Serious Adverse Events |
||||
WaveWriter Settings | Conventional Settings | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/5 (0%) | 0/4 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
WaveWriter Settings | Conventional Settings | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 2/5 (40%) | 0/4 (0%) | ||
Injury, poisoning and procedural complications | ||||
Wound | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
Vascular disorders | ||||
Shock | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Roshini Jain, Sr. Director Clinical Sciences |
---|---|
Organization | Boston Scientific |
Phone | 16619494350 |
roshini.jain@bsci.com |
- 92285183