Trial Outcomes & Findings for Comparison of the Effects of Two Spinal Cord Stimulation (SCS) Therapies on Subject Reported Pain (BENEFIT-02) (NCT NCT03594266)
NCT ID: NCT03594266
Last Updated: 2023-07-10
Results Overview
The purpose of primary endpoint 1 is to evaluate the change since baseline in Numerical Rating Scale (NRS) for pain (overall) for each study SCS therapy. The evaluation of primary endpoint 1 is based on the NRS for pain (overall) obtained at the final study testing visit compared with the baseline measurement obtained prior to initiation of the commercial trial period, for subjects randomized to each study SCS therapy. Numerical Rating Scale (NRS) was collected for overall pain experienced over the past 24 hours on a scale of 0-10, with 0 being No Pain and 10 being Worst Possible Pain.
COMPLETED
NA
136 participants
Baseline and in-office visit 3, average of 21 days
2023-07-10
Participant Flow
Of 136 provisionally enrolled participants, 77 met the criteria to be randomized to treatment.
Participant milestones
| Measure |
Therapy A Spinal Cord Stimulation Parameter Set
Therapy A (\~600-1500Hz) spinal cord stimulation parameter set using BIO-RNA system and associated components.
|
Therapy B Spinal Cord Stimulation Parameter Set
Therapy B (\~300-600Hz) spinal cord stimulation parameter set using BIO-RNA system and associated components.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
39
|
|
Overall Study
COMPLETED
|
31
|
34
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of the Effects of Two Spinal Cord Stimulation (SCS) Therapies on Subject Reported Pain (BENEFIT-02)
Baseline characteristics by cohort
| Measure |
Enrolled But Not Randomized
n=59 Participants
Subjects selected for participation from the investigator's patient population who have signed the Informed Consent Form, have confirmation of the initial enrollment criteria, and have completed baseline measurements, but did not meet criteria to be randomized at office visit 1.
|
Therapy A
n=38 Participants
Subjects meeting all eligibility criteria at office visit 1 and are subsequently randomized to Therapy A (\~600-1500Hz) spinal cord stimulation parameter set.
|
Therapy B
n=39 Participants
Subjects meeting all eligibility criteria at office visit 1 and are subsequently randomized to Therapy B (\~300-600Hz) spinal cord stimulation parameter set.
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.9 Years
STANDARD_DEVIATION 12.09 • n=5 Participants
|
60.8 Years
STANDARD_DEVIATION 13.25 • n=7 Participants
|
60.4 Years
STANDARD_DEVIATION 13.79 • n=5 Participants
|
62 Years
STANDARD_DEVIATION 12.93 • n=4 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
114 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
109 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Clinical Characteristics - Primary Pain Diagnosis
Failed back surgery syndrome
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Clinical Characteristics - Primary Pain Diagnosis
Radiculopathy
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Clinical Characteristics - Primary Pain Diagnosis
Complex regional pain syndrome
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Clinical Characteristics - Primary Pain Diagnosis
Chronic pain syndrome
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Clinical Characteristics - Primary Pain Diagnosis
Degenerative disc disease
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Clinical Characteristics - Primary Pain Diagnosis
Spinal stenosis
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Clinical Characteristics - Primary Pain Diagnosis
Low back pain
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Clinical Characteristics - Primary Pain Diagnosis
Dorsalgia
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Clinical Characteristics - Primary Pain Diagnosis
Spondylosis
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Clinical Characteristics - Primary Pain Diagnosis
Other primary pain diagnosis
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Clinical Characteristics - Primary Pain Diagnosis
Unknown primary pain diagnosis
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Clinical Characteristics - Previous Back Surgery
Yes
|
31 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Clinical Characteristics - Previous Back Surgery
No
|
27 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Clinical Characteristics - Previous Back Surgery
Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Clinical Characteristics - Taking Opioid Analgesics
Yes
|
34 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Clinical Characteristics - Taking Opioid Analgesics
No
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Clinical Characteristics - Taking Opioid Analgesics
Unknown
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and in-office visit 3, average of 21 daysPopulation: Only patients with valid NRS for pain (overall) at both baseline and at in-office visit 3 were evaluated for this endpoint.
The purpose of primary endpoint 1 is to evaluate the change since baseline in Numerical Rating Scale (NRS) for pain (overall) for each study SCS therapy. The evaluation of primary endpoint 1 is based on the NRS for pain (overall) obtained at the final study testing visit compared with the baseline measurement obtained prior to initiation of the commercial trial period, for subjects randomized to each study SCS therapy. Numerical Rating Scale (NRS) was collected for overall pain experienced over the past 24 hours on a scale of 0-10, with 0 being No Pain and 10 being Worst Possible Pain.
Outcome measures
| Measure |
Therapy A Spinal Cord Stimulation Parameter Set
n=24 Participants
Therapy A (\~600-1500Hz) spinal cord stimulation parameter set using BIO-RNA system and associated components.
|
Therapy B Spinal Cord Stimulation Parameter Set
n=23 Participants
Therapy B (\~300-600Hz) spinal cord stimulation parameter set using BIO-RNA system and associated components.
|
|---|---|---|
|
Change Since Baseline in Numerical Rating Scale (NRS) for Pain (Overall) Evaluated Separately for Each Study SCS Therapy
|
-4.3 Score on a scale
Standard Deviation 0.47
|
-4.7 Score on a scale
Standard Deviation 0.48
|
PRIMARY outcome
Timeframe: Baseline and in-office visit 3, average of 21 daysPopulation: Only patients with valid NRS for pain (overall) at both baseline and at in-office visit 3 were evaluated for this endpoint.
The purpose of primary endpoint 2 is to provide an inter-therapy comparison of change since baseline in Numerical Rating Scale (NRS) for pain (overall). Primary endpoint 2 analyses includes all participants included in primary endpoint 1 analyses. Numerical Rating Scale (NRS) was collected for overall pain experienced over the past 24 hours on a scale of 0-10, with 0 being No Pain and 10 being Worst Possible Pain.
Outcome measures
| Measure |
Therapy A Spinal Cord Stimulation Parameter Set
n=24 Participants
Therapy A (\~600-1500Hz) spinal cord stimulation parameter set using BIO-RNA system and associated components.
|
Therapy B Spinal Cord Stimulation Parameter Set
n=23 Participants
Therapy B (\~300-600Hz) spinal cord stimulation parameter set using BIO-RNA system and associated components.
|
|---|---|---|
|
Inter-therapy Comparison of Change Since Baseline in Numerical Rating Scale (NRS) for Pain (Overall)
|
-4.3 Score on a scale
Standard Deviation 0.47
|
-4.7 Score on a scale
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: In-office visit 1 at approximately 7 days and in-office visit 3 at approximately 21 days, average of 14 daysPopulation: Only patients with valid NRS for pain (overall) at both in-office visit 1 and in-office visit 3 were evaluated for this endpoint.
The evaluation of secondary endpoint 1 will be based on Numerical Rating Scale (NRS) for overall pain experienced over the past 24 hours (scale of 0-10, with 0 being No Pain and 10 being Worst Possible Pain) obtained at conclusion of commercial trial compared to NRS for overall pain at the final study testing visit
Outcome measures
| Measure |
Therapy A Spinal Cord Stimulation Parameter Set
n=24 Participants
Therapy A (\~600-1500Hz) spinal cord stimulation parameter set using BIO-RNA system and associated components.
|
Therapy B Spinal Cord Stimulation Parameter Set
n=23 Participants
Therapy B (\~300-600Hz) spinal cord stimulation parameter set using BIO-RNA system and associated components.
|
|---|---|---|
|
Change Since Conclusion of Commercial Trial in Numerical Rating Scale (NRS) for Pain (Overall) Evaluated Separately for Each Study SCS Therapy
|
1.0 Score on a scale
Standard Deviation 0.53
|
0.3 Score on a scale
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: Baseline and in-office visit 3, average of 21 daysPopulation: Evaluable subjects for secondary endpoint 2 will include all subjects who undergo randomization and have the investigational stimulation system connected to their SCS trial leads. The investigational device-related adverse event-free rate was pre-defined within the protocol as the overall rate from all implanted Prospera SCS devices, regardless of randomized therapy output setting (Therapy A or Therapy B). Therefore, data for Therapy A and Therapy B are combined for this outcome measure.
The evaluation of secondary endpoint 2 will be based on the number of subjects free from investigational device-related adverse events assessed at in-office visit 1 (randomization visit) through in-office visit 3 (study completion). The investigational device-related adverse event-free rate was pre-defined within the protocol as the overall rate from all implanted Prospera SCS devices, regardless of randomized therapy output setting (Therapy A or Therapy B).
Outcome measures
| Measure |
Therapy A Spinal Cord Stimulation Parameter Set
n=77 Participants
Therapy A (\~600-1500Hz) spinal cord stimulation parameter set using BIO-RNA system and associated components.
|
Therapy B Spinal Cord Stimulation Parameter Set
Therapy B (\~300-600Hz) spinal cord stimulation parameter set using BIO-RNA system and associated components.
|
|---|---|---|
|
Investigational Device-related Adverse Event-free Rate
|
76 Participants
|
—
|
Adverse Events
Enrolled But Not Randomized
Therapy A
Therapy B
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Enrolled But Not Randomized
n=59 participants at risk
Subjects selected for participation from the investigator's patient population who have signed the Informed Consent Form and have confirmation of the initial enrollment criteria but have not yet been randomized.
|
Therapy A
n=38 participants at risk
Subjects meeting all eligibility criteria who have been randomized to the Therapy A (\~600-1500Hz) spinal cord stimulation parameter set.
|
Therapy B
n=39 participants at risk
Subjects meeting all eligibility criteria who have been randomized to the Therapy B (\~300-600Hz) spinal cord stimulation parameter set.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Irritation from wound dressing
|
0.00%
0/59 • 21 days
|
0.00%
0/38 • 21 days
|
2.6%
1/39 • Number of events 1 • 21 days
|
|
Surgical and medical procedures
Lead migration
|
0.00%
0/59 • 21 days
|
0.00%
0/38 • 21 days
|
2.6%
1/39 • Number of events 1 • 21 days
|
|
Skin and subcutaneous tissue disorders
Reaction from wound dressing
|
0.00%
0/59 • 21 days
|
2.6%
1/38 • Number of events 1 • 21 days
|
2.6%
1/39 • Number of events 1 • 21 days
|
|
Surgical and medical procedures
Persistent post-surgical site pain
|
1.7%
1/59 • Number of events 1 • 21 days
|
0.00%
0/38 • 21 days
|
0.00%
0/39 • 21 days
|
|
Renal and urinary disorders
Urinary incontinence
|
1.7%
1/59 • Number of events 1 • 21 days
|
0.00%
0/38 • 21 days
|
0.00%
0/39 • 21 days
|
|
Product Issues
Neurostimulator device entered "safe mode"
|
0.00%
0/59 • 21 days
|
2.6%
1/38 • Number of events 1 • 21 days
|
0.00%
0/39 • 21 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place