Trial Outcomes & Findings for Field Shape and Amplitude Sensitivity Exploratory Study (CONTOUR Study) (NCT NCT02916498)
NCT ID: NCT02916498
Last Updated: 2021-01-29
Results Overview
Number of participants preferring bipolar field shape and alternative field shape
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
42 days post randomization
Results posted on
2021-01-29
Participant Flow
16 subjects were enrolled in the study. 10 were withdrawn prior to randomization. 6 were randomized. Statistically relevant conclusions cannot be made from this small sample size.
Participant milestones
| Measure |
Bipolar Then Alternative Field Shape Stimulation
Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with bipolar stimulation for 21 days, then alternative field shape stimulation for 21 days
|
Alternative Then Bipolar Field Shape Stimulation
Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with alternative field stimulation for 21 days, then bipolar shape stimulation for 21 days
|
|---|---|---|
|
First Intervention, 21 Days
STARTED
|
2
|
4
|
|
First Intervention, 21 Days
COMPLETED
|
2
|
4
|
|
First Intervention, 21 Days
NOT COMPLETED
|
0
|
0
|
|
Second Intervention, 21 Days
STARTED
|
2
|
4
|
|
Second Intervention, 21 Days
COMPLETED
|
2
|
4
|
|
Second Intervention, 21 Days
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Bipolar Then Alternative Field Shape Stimulation
n=2 Participants
Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with bipolar stimulation for 21 days, then alternative field shape stimulation for 21 days
|
Alternative Then Bipolar Field Shape Stimulation
n=4 Participants
Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with alternative field shape stimulation for 21 days, then bipolar stimulation for 21 days
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=2 Participants
|
4 participants
n=4 Participants
|
6 participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=2 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=6 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 42 days post randomizationNumber of participants preferring bipolar field shape and alternative field shape
Outcome measures
| Measure |
Bipolar Then Alternative Field Shape Stimulation
n=2 Participants
Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with bipolar stimulation for 21 days, then alternative field shape stimulation for 21 days
|
Alternative Then Bipolar Field Shape Stimulation
n=4 Participants
Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with alternative field shape stimulation for 21 days, then bipolar stimulation for 21 days
|
|---|---|---|
|
Patient Preferred Field Shape
Preferred Bipolar Field Shape
|
2 Participants
|
2 Participants
|
|
Patient Preferred Field Shape
Preferred Alternative Field Shape
|
0 Participants
|
2 Participants
|
Adverse Events
Bipolar Field Shape Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Alternative Field Shape 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