Trial Outcomes & Findings for Effectiveness of the Precision Spinal Cord Stimulator System at Sub-Perception Amplitude (NCT NCT02314000)
NCT ID: NCT02314000
Last Updated: 2021-02-11
Results Overview
Proportion of subjects with 50% or greater reduction in overall pain intensity from baseline with supra and sub perception amplitude with no increase in average daily medication intake to treat pain
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
229 participants
Primary outcome timeframe
90 days post activation
Results posted on
2021-02-11
Participant Flow
Enrolled subjects underwent study eligibility to determine if they can continue in the study. Following completion of study eligibility, subjects were randomized to the cross-over phase.
Participant milestones
| Measure |
SCS Starting With Supra-perception Amplitude
Precision or Precision Spectra Spinal Cord Stimulator System programmed starting with supra-perception followed by sub-perception amplitude.
Precision or Precision Spectra Spinal Cord Stimulator System
|
SCS Starting With Sub-perception Amplitude
Precision or Precision Spectra Spinal Cord Stimulator System programmed starting with sub-perception and followed by supra-perception amplitude.
Precision or Precision Spectra Spinal Cord Stimulator System
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
65
|
|
Overall Study
COMPLETED
|
62
|
57
|
|
Overall Study
NOT COMPLETED
|
13
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of the Precision Spinal Cord Stimulator System at Sub-Perception Amplitude
Baseline characteristics by cohort
| Measure |
SCS Starting at Supra-perception Amplitude
n=75 Participants
Precision or Precision Spectra Spinal Cord Stimulator System programmed starting at supra-perception and followed by sub-perception amplitude.
Precision or Precision Spectra Spinal Cord Stimulator System
|
SCS Starting at Sub-perception Amplitude
n=65 Participants
Precision or Precision Spectra Spinal Cord Stimulator System starting at sub-perception and followed by supra-perception amplitude.
Precision or Precision Spectra Spinal Cord Stimulator System
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.7 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
58.8 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
59.8 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 90 days post activationPopulation: Due to the nature of crossover study design, all subjects contributed towards each arm, as reflected in the number of participants.
Proportion of subjects with 50% or greater reduction in overall pain intensity from baseline with supra and sub perception amplitude with no increase in average daily medication intake to treat pain
Outcome measures
| Measure |
SCS With Supra-perception Amplitude
n=119 Participants
Precision or Precision Spectra Spinal Cord Stimulator System programmed at supra-perception amplitude
Precision or Precision Spectra Spinal Cord Stimulator System
|
SCS With Sub-perception Amplitude
n=118 Participants
Precision or Precision Spectra Spinal Cord Stimulator System programmed at sub-perception amplitude
Precision or Precision Spectra Spinal Cord Stimulator System
|
|---|---|---|
|
Proportion of Subjects With 50% or Greater Reduction in Overall Pain Intensity From Baseline
|
32 Participants
|
41 Participants
|
Adverse Events
All Study Patients Through End of Randomized Phase
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
SCS With Supra Perception Amplitude
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
SCS With Subperception Amplitude
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Study Patients Through End of Randomized Phase
n=140 participants at risk
All adverse events reported through end of randomized phase
|
SCS With Supra Perception Amplitude
n=140 participants at risk
All adverse events during SCS with supra perception amplitude
|
SCS With Subperception Amplitude
n=140 participants at risk
All adverse events during SCS with supra perception amplitude
|
|---|---|---|---|
|
Infections and infestations
Gastroenteritis
|
0.71%
1/140 • Number of events 1 • Adverse events up to end of cross over period - approximately upto 180 days after randomization
Adverse events up to end of cross over period - approximately upto 180 days after randomization
|
0.71%
1/140 • Number of events 1 • Adverse events up to end of cross over period - approximately upto 180 days after randomization
Adverse events up to end of cross over period - approximately upto 180 days after randomization
|
0.00%
0/140 • Adverse events up to end of cross over period - approximately upto 180 days after randomization
Adverse events up to end of cross over period - approximately upto 180 days after randomization
|
|
Infections and infestations
Pneumonia
|
1.4%
2/140 • Number of events 2 • Adverse events up to end of cross over period - approximately upto 180 days after randomization
Adverse events up to end of cross over period - approximately upto 180 days after randomization
|
0.71%
1/140 • Number of events 1 • Adverse events up to end of cross over period - approximately upto 180 days after randomization
Adverse events up to end of cross over period - approximately upto 180 days after randomization
|
0.71%
1/140 • Number of events 1 • Adverse events up to end of cross over period - approximately upto 180 days after randomization
Adverse events up to end of cross over period - approximately upto 180 days after randomization
|
|
Infections and infestations
Cystitis
|
0.71%
1/140 • Number of events 1 • Adverse events up to end of cross over period - approximately upto 180 days after randomization
Adverse events up to end of cross over period - approximately upto 180 days after randomization
|
0.00%
0/140 • Adverse events up to end of cross over period - approximately upto 180 days after randomization
Adverse events up to end of cross over period - approximately upto 180 days after randomization
|
0.71%
1/140 • Number of events 1 • Adverse events up to end of cross over period - approximately upto 180 days after randomization
Adverse events up to end of cross over period - approximately upto 180 days after randomization
|
|
Gastrointestinal disorders
Diverticular Perforation
|
0.71%
1/140 • Number of events 1 • Adverse events up to end of cross over period - approximately upto 180 days after randomization
Adverse events up to end of cross over period - approximately upto 180 days after randomization
|
0.00%
0/140 • Adverse events up to end of cross over period - approximately upto 180 days after randomization
Adverse events up to end of cross over period - approximately upto 180 days after randomization
|
0.71%
1/140 • Number of events 1 • Adverse events up to end of cross over period - approximately upto 180 days after randomization
Adverse events up to end of cross over period - approximately upto 180 days after randomization
|
|
Gastrointestinal disorders
Enterocolitis Heamorrhagic
|
0.71%
1/140 • Number of events 1 • Adverse events up to end of cross over period - approximately upto 180 days after randomization
Adverse events up to end of cross over period - approximately upto 180 days after randomization
|
0.00%
0/140 • Adverse events up to end of cross over period - approximately upto 180 days after randomization
Adverse events up to end of cross over period - approximately upto 180 days after randomization
|
0.71%
1/140 • Number of events 1 • Adverse events up to end of cross over period - approximately upto 180 days after randomization
Adverse events up to end of cross over period - approximately upto 180 days after randomization
|
|
Infections and infestations
Post Procedure Infection
|
0.71%
1/140 • Number of events 1 • Adverse events up to end of cross over period - approximately upto 180 days after randomization
Adverse events up to end of cross over period - approximately upto 180 days after randomization
|
0.71%
1/140 • Number of events 1 • Adverse events up to end of cross over period - approximately upto 180 days after randomization
Adverse events up to end of cross over period - approximately upto 180 days after randomization
|
0.00%
0/140 • Adverse events up to end of cross over period - approximately upto 180 days after randomization
Adverse events up to end of cross over period - approximately upto 180 days after randomization
|
|
Renal and urinary disorders
Renal Failure
|
0.71%
1/140 • Number of events 1 • Adverse events up to end of cross over period - approximately upto 180 days after randomization
Adverse events up to end of cross over period - approximately upto 180 days after randomization
|
0.71%
1/140 • Number of events 1 • Adverse events up to end of cross over period - approximately upto 180 days after randomization
Adverse events up to end of cross over period - approximately upto 180 days after randomization
|
0.00%
0/140 • Adverse events up to end of cross over period - approximately upto 180 days after randomization
Adverse events up to end of cross over period - approximately upto 180 days after randomization
|
Other adverse events
Adverse event data not reported
Additional Information
Roshini Jain, Director of Clinical Sciences
Boston Scientific
Phone: 6619494355
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Clinical study agreement that restricts PI until official study manuscript is available.
- Publication restrictions are in place
Restriction type: OTHER