Trial Outcomes & Findings for SCS Programming Study in Treating Intractable Chronic Back Pain (NOVA) (NCT NCT04571242)
NCT ID: NCT04571242
Last Updated: 2024-07-15
Results Overview
The primary outcome measure is the percentage of randomized subjects (who completed the trial phase) who respond to SCS therapy at 3-months after device activation. An individual responder is a subject that experiences at least a 50% decrease in back pain relative to baseline assessment.
COMPLETED
NA
126 participants
3 months
2024-07-15
Participant Flow
121 subjects met inclusion and exclusion criteria after enrollment were randomized (5 subjects failed screening). 105 subjects successfully randomized subjects completed the trial phase and were included in the Modified Intent to Treat Analysis.
Participant milestones
| Measure |
DTM-SCS Programming Group
DTM-SCS program group has at least two programs with different pulse rate in the 50 to 1,000 Hz range and each having a maximum pulse width of 1 ms.
|
Conventional SCS Programming Group
Conventional SCS program group has stimulation parameters in the 40-250 Hz frequency range will be trialed according to standard practice as described in the Intellis labeling/manuals.
|
|---|---|---|
|
3 Months
STARTED
|
51
|
54
|
|
3 Months
COMPLETED
|
46
|
44
|
|
3 Months
NOT COMPLETED
|
5
|
10
|
|
6 Months
STARTED
|
46
|
44
|
|
6 Months
COMPLETED
|
42
|
43
|
|
6 Months
NOT COMPLETED
|
4
|
1
|
|
9 Months
STARTED
|
56
|
29
|
|
9 Months
COMPLETED
|
56
|
28
|
|
9 Months
NOT COMPLETED
|
0
|
1
|
|
12 Months
STARTED
|
56
|
28
|
|
12 Months
COMPLETED
|
55
|
28
|
|
12 Months
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
DTM-SCS Programming Group
n=51 Participants
DTM-SCS program group has at least two programs with different pulse rate in the 50 to 1,000 Hz range and each having a maximum pulse width of 1 ms.
|
Conventional SCS Programming Group
n=54 Participants
Conventional SCS program group has stimulation parameters in the 40-250 Hz frequency range will be trialed according to standard practice as described in the Intellis labeling/manuals.
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.9 years
STANDARD_DEVIATION 13.5 • n=51 Participants
|
59.6 years
STANDARD_DEVIATION 12.1 • n=54 Participants
|
61.2 years
STANDARD_DEVIATION 12.8 • n=105 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=51 Participants
|
33 Participants
n=54 Participants
|
62 Participants
n=105 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=51 Participants
|
21 Participants
n=54 Participants
|
43 Participants
n=105 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
51 participants
n=51 Participants
|
54 participants
n=54 Participants
|
105 participants
n=105 Participants
|
|
Back Pain VAS
|
7.9 units on a scale
STANDARD_DEVIATION 1.0 • n=51 Participants
|
8.0 units on a scale
STANDARD_DEVIATION 1.1 • n=54 Participants
|
8.0 units on a scale
STANDARD_DEVIATION 1.0 • n=105 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Modified Intent to Treat (mITT): All successfully randomized subjects who complete the Trial Phase. Failed trial subjects and subjects that withdrew due to insufficient pain relief carry forward.
The primary outcome measure is the percentage of randomized subjects (who completed the trial phase) who respond to SCS therapy at 3-months after device activation. An individual responder is a subject that experiences at least a 50% decrease in back pain relative to baseline assessment.
Outcome measures
| Measure |
DTM-SCS Programming Group
n=46 Participants
DTM-SCS program group has at least two programs with different pulse rate in the 50 to 1,000 Hz range and each having a maximum pulse width of 1 ms.
|
Conventional SCS Programming Group
n=44 Participants
Conventional SCS program group has stimulation parameters in the 40-250 Hz frequency range will be trialed according to standard practice as described in the Intellis labeling/manuals.
|
|---|---|---|
|
Percentage of Subjects Who Respond to DTM-SCS Therapy Compared to Conventional SCS Therapy
|
93.5 percentage of participants
Interval 81.6 to 97.9
|
36.4 percentage of participants
Interval 23.6 to 51.4
|
Adverse Events
DTM-SCS Programming Group
Conventional SCS Programming Group
Serious adverse events
| Measure |
DTM-SCS Programming Group
n=51 participants at risk
DTM-SCS program group has at least two programs with different pulse rate in the 50 to 1,000 Hz range and each having a maximum pulse width of 1 ms. All reported adverse events occurred prior to the optional crossover.
|
Conventional SCS Programming Group
n=54 participants at risk
Conventional SCS program group has stimulation parameters in the 40-250 Hz frequency range will be trialed according to standard practice as described in the Intellis labeling/manuals. All reported adverse events occurred prior to the optional crossover.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Spinal Epidural Hematoma
|
2.0%
1/51 • Number of events 2 • 1 year
|
0.00%
0/54 • 1 year
|
|
Nervous system disorders
Post Dural Puncture Headache
|
0.00%
0/51 • 1 year
|
1.9%
1/54 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pocket Pain
|
0.00%
0/51 • 1 year
|
1.9%
1/54 • Number of events 1 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place