Trial Outcomes & Findings for Optimal Stimulation Programming for Spinal Peripheral Neuromodulation (NCT NCT02346383)
NCT ID: NCT02346383
Last Updated: 2021-03-16
Results Overview
0 (no pain)- 10 (worst pain imaginable)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Weeks 4, 6 and 8
Results posted on
2021-03-16
Participant Flow
Participant milestones
| Measure |
All Study Participants
Participants were randomized to 1 of 3 programs. Data were collected every 2 weeks at the completion of each program. Participants chose their preferred program from the previous 3 for the next 12 weeks.
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimal Stimulation Programming for Spinal Peripheral Neuromodulation
Baseline characteristics by cohort
| Measure |
All Study Participants
n=40 Participants
Participants were randomized to 1 of 3 programs. Data were collected every 2 weeks at the completion of each program. Participants chose their preferred program from the previous 3 for the next 12 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
50 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
40 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Weeks 4, 6 and 80 (no pain)- 10 (worst pain imaginable)
Outcome measures
| Measure |
Program 1
n=40 Participants
preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs
preset program: Change to different present program using epidural and peripheral lead to cover pain
|
Program 2
n=40 Participants
preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs
preset program: Change to different present program using epidural and peripheral lead to cover pain
|
Program 3
n=40 Participants
preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs
preset program: Change to different present program using epidural and peripheral lead to cover pain
|
|---|---|---|---|
|
Numeric Rating Scale (Pain)
|
5.2 units on a scale
Standard Deviation 1.6
|
5.2 units on a scale
Standard Deviation 2.2
|
5.3 units on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: weeks 4, 6, and 8percentage of pain relief- self report
Outcome measures
| Measure |
Program 1
n=40 Participants
preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs
preset program: Change to different present program using epidural and peripheral lead to cover pain
|
Program 2
n=40 Participants
preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs
preset program: Change to different present program using epidural and peripheral lead to cover pain
|
Program 3
n=40 Participants
preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs
preset program: Change to different present program using epidural and peripheral lead to cover pain
|
|---|---|---|---|
|
Percent Pain Relief- Subject Self-reported Percentage of Relief With Each Program.
|
52 percentage of pain relief
Standard Deviation 22
|
46 percentage of pain relief
Standard Deviation 27
|
46 percentage of pain relief
Standard Deviation 21
|
Adverse Events
Program 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Program 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Program 3
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place