Trial Outcomes & Findings for Study to Characterize Effects of Programming in SCS Patients Undergoing a Temporary Trial (NCT NCT02988713)
NCT ID: NCT02988713
Last Updated: 2022-04-18
Results Overview
Number of participants reporting comfort level of stimulation sensation as "Very Comfortable" or "Slightly Comfortable"
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
An estimated average of 7 days post temporary trial procedure
Results posted on
2022-04-18
Participant Flow
35 subjects were enrolled in and started the study. 2 were withdrawn prior to the Programming Visit. 33 started the Programming Visit and 32 completed the study. Statistically relevant conclusions cannot be made from this small sample size.
Participant milestones
| Measure |
Spinal Cord Stimulation
Spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial
Programming: Programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Spinal Cord Stimulation
Spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial
Programming: Programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Subject's failure to meet study inclusion or exclusion criteria after enrollment
|
2
|
Baseline Characteristics
Analysis population n = 35. Measures are not mutually exclusive: one subject reported Work Status of both "Unemployed" and "Retired". Additionally, one subject did not report work status.
Baseline characteristics by cohort
| Measure |
Spinal Cord Stimulation
n=35 Participants
Spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial
Programming: Programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
|
Work Status
Disability
|
6 participants
n=5 Participants • Analysis population n = 35. Measures are not mutually exclusive: one subject reported Work Status of both "Unemployed" and "Retired". Additionally, one subject did not report work status.
|
|
Work Status
Employed
|
8 participants
n=5 Participants • Analysis population n = 35. Measures are not mutually exclusive: one subject reported Work Status of both "Unemployed" and "Retired". Additionally, one subject did not report work status.
|
|
Work Status
Retired
|
14 participants
n=5 Participants • Analysis population n = 35. Measures are not mutually exclusive: one subject reported Work Status of both "Unemployed" and "Retired". Additionally, one subject did not report work status.
|
|
Work Status
Student
|
1 participants
n=5 Participants • Analysis population n = 35. Measures are not mutually exclusive: one subject reported Work Status of both "Unemployed" and "Retired". Additionally, one subject did not report work status.
|
|
Work Status
Unemployed
|
6 participants
n=5 Participants • Analysis population n = 35. Measures are not mutually exclusive: one subject reported Work Status of both "Unemployed" and "Retired". Additionally, one subject did not report work status.
|
|
Work Status
Not reported
|
1 participants
n=5 Participants • Analysis population n = 35. Measures are not mutually exclusive: one subject reported Work Status of both "Unemployed" and "Retired". Additionally, one subject did not report work status.
|
PRIMARY outcome
Timeframe: An estimated average of 7 days post temporary trial procedurePopulation: 32 subjects completing the Programming Visit
Number of participants reporting comfort level of stimulation sensation as "Very Comfortable" or "Slightly Comfortable"
Outcome measures
| Measure |
Spinal Cord Stimulation
n=32 Participants
Spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial
Programming: Programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial
|
|---|---|
|
Patient Comfort
|
30 Participants
|
Adverse Events
Spinal Cord Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director, Clinical Sciences and Scientific Communication
Boston Scientific
Phone: 855-213-9890
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60