Trial Outcomes & Findings for Spinal Cord Stimulation (SCS) Dosing Study (NCT NCT03284411)
NCT ID: NCT03284411
Last Updated: 2020-04-15
Results Overview
To characterize the effect of four different amplitude settings on baseline SCS therapy satisfaction. At each follow-up visit, the following question was asked to measure satisfaction: "Overall how satisfied or unsatisfied are you with this therapy?". The response choices were as follows: "very satisfied", "somewhat satisfied", "neutral", "somewhat unsatisfied", "very unsatisfied". Each subject was considered to have maintained their baseline SCS therapy satisfaction if they selected the response "very satisfied", "somewhat satisfied", or "neutral", otherwise they were considered dissatisfied with the therapy. The first visit in which each subject reported dissatisfaction of the therapy was recorded. The amplitude used during the prior visit was then considered to be the minimum amplitude that maintained each subject's therapy satisfaction. The frequency and percentage of subjects' that maintained baseline satisfaction were reported at each amplitude level.
COMPLETED
PHASE4
30 participants
8 weeks
2020-04-15
Participant Flow
Participant milestones
| Measure |
Spinal Cord Stimulation
Each subject was programmed to 4 different amplitude settings (80, 60, 40, and 20 percent of their perception threshold amplitude).
Spinal Cord Stimulation: Programming
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Spinal Cord Stimulation (SCS) Dosing Study
Baseline characteristics by cohort
| Measure |
Spinal Cord Stimulation
n=30 Participants
Each subject was programmed to 4 different amplitude settings (80, 60, 40, and 20 percent of their perception threshold).
Spinal Cord Stimulation: Programming
|
|---|---|
|
Age, Continuous
|
65.1 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksTo characterize the effect of four different amplitude settings on baseline SCS therapy satisfaction. At each follow-up visit, the following question was asked to measure satisfaction: "Overall how satisfied or unsatisfied are you with this therapy?". The response choices were as follows: "very satisfied", "somewhat satisfied", "neutral", "somewhat unsatisfied", "very unsatisfied". Each subject was considered to have maintained their baseline SCS therapy satisfaction if they selected the response "very satisfied", "somewhat satisfied", or "neutral", otherwise they were considered dissatisfied with the therapy. The first visit in which each subject reported dissatisfaction of the therapy was recorded. The amplitude used during the prior visit was then considered to be the minimum amplitude that maintained each subject's therapy satisfaction. The frequency and percentage of subjects' that maintained baseline satisfaction were reported at each amplitude level.
Outcome measures
| Measure |
Spinal Cord Stimulation
n=30 Participants
Each subject was programmed to 4 different amplitude settings (80, 60, 40, and 20 percent of perception threshold).
Spinal Cord Stimulation: Programming
|
|---|---|
|
SCS Therapy Satisfaction
80% perception threshold
|
2 Participants
|
|
SCS Therapy Satisfaction
Baseline
|
6 Participants
|
|
SCS Therapy Satisfaction
60% perception threshold
|
1 Participants
|
|
SCS Therapy Satisfaction
40% perception threshold
|
0 Participants
|
|
SCS Therapy Satisfaction
20% perception threshold
|
21 Participants
|
SECONDARY outcome
Timeframe: 8 weeksTo characterize the effect of four different amplitude settings on baseline pain relief. During each follow-up period the VAS pain score was recorded once a day, on a multi-day diary, where subjects rated their pain by making a vertical slash mark through the 0-10 cm line that best described their pain during the last 24 hours, with 0 = No pain and 10 = Worst pain imaginable. The higher VAS pain score represented worse pain. The average VAS pain scores from the last 3 days of the diary prior to the scheduled visit was used for analysis. Each subject was considered to have maintained their baseline pain if there was less than a 2 point increase in their average pain score at the follow-up period. The amplitude used during the prior visit was then considered to be the minimum amplitude that maintained the subject's pain relief. The frequency and percentage of subjects' that maintained their average baseline VAS pain score were reported at each amplitude level.
Outcome measures
| Measure |
Spinal Cord Stimulation
n=30 Participants
Each subject was programmed to 4 different amplitude settings (80, 60, 40, and 20 percent of perception threshold).
Spinal Cord Stimulation: Programming
|
|---|---|
|
Number of Participants Maintaining Baseline Pain as Measured on the Visual Analog Scale (VAS)
Baseline
|
5 Participants
|
|
Number of Participants Maintaining Baseline Pain as Measured on the Visual Analog Scale (VAS)
80% perception threshold
|
3 Participants
|
|
Number of Participants Maintaining Baseline Pain as Measured on the Visual Analog Scale (VAS)
60% perception threshold
|
1 Participants
|
|
Number of Participants Maintaining Baseline Pain as Measured on the Visual Analog Scale (VAS)
40% perception threshold
|
2 Participants
|
|
Number of Participants Maintaining Baseline Pain as Measured on the Visual Analog Scale (VAS)
20% perception threshold
|
19 Participants
|
Adverse Events
Spinal Cord Stimulation
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Spinal Cord Stimulation
n=30 participants at risk
Each subject was programmed to 4 different amplitude settings (80, 60, 40, and 20 percent of their perception threshold)
Spinal Cord Stimulation: Programming
|
|---|---|
|
Product Issues
Device stimulation issue
|
10.0%
3/30 • Number of events 3 • Adverse events were collected from enrollment to study discontinuation with an average of 2.2 months
|
|
General disorders
Inadequate analgesia
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from enrollment to study discontinuation with an average of 2.2 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from enrollment to study discontinuation with an average of 2.2 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place