Trial Outcomes & Findings for Fast-Acting Subperception Study (FAST) (NCT NCT04231409)
NCT ID: NCT04231409
Last Updated: 2022-01-24
Results Overview
Proportion of subjects with 50% or greater reduction from Baseline Visit in average overall pain intensity at 3 months post-randomization
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
3 months post-randomization
Results posted on
2022-01-24
Participant Flow
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).
Participant milestones
| Measure |
WaveWriter Settings
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 Settings
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.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fast-Acting Subperception Study (FAST)
Baseline characteristics by cohort
| Measure |
WaveWriter Settings
n=5 Participants
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 Settings
n=4 Participants
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
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.2 years
STANDARD_DEVIATION 16.5 • n=99 Participants
|
57.3 years
STANDARD_DEVIATION 7.3 • n=107 Participants
|
58.3 years
STANDARD_DEVIATION 12.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Overall Pain Score
|
7.6 units on a scale
STANDARD_DEVIATION 0.9 • n=99 Participants
|
7.3 units on a scale
STANDARD_DEVIATION 1.0 • n=107 Participants
|
7.4 units on a scale
STANDARD_DEVIATION 0.9 • n=206 Participants
|
PRIMARY outcome
Timeframe: 3 months post-randomizationPopulation: Data not collected and hence not available due to termination of the study (Follow-up activities affected by COVID-19)
Proportion of subjects with 50% or greater reduction from Baseline Visit in average overall pain intensity at 3 months post-randomization
Outcome measures
Outcome data not reported
Adverse Events
WaveWriter Settings
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Conventional Settings
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
WaveWriter Settings
n=5 participants at risk
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 Settings
n=4 participants at risk
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.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Wound
|
20.0%
1/5 • Number of events 1 • Adverse events up to end of randomized phase (3 months)
|
0.00%
0/4 • Adverse events up to end of randomized phase (3 months)
|
|
Vascular disorders
Shock
|
20.0%
1/5 • Number of events 1 • Adverse events up to end of randomized phase (3 months)
|
0.00%
0/4 • Adverse events up to end of randomized phase (3 months)
|
Additional Information
Roshini Jain, Sr. Director Clinical Sciences
Boston Scientific
Phone: 16619494350
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place