Trial Outcomes & Findings for Combining Mechanisms for Better Outcomes (COMBO) (NCT NCT03689920)
NCT ID: NCT03689920
Last Updated: 2022-01-11
Results Overview
Percentage of subjects with 50% or greater reduction from Baseline Visit in average overall pain intensity at 3 months post-randomization with no increase in opioid medications
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
174 participants
Primary outcome timeframe
3 months post-randomization
Results posted on
2022-01-11
Participant Flow
After subjects were enrolled, they were evaluated per study eligibility criteria. Only those who met all criteria proceeded to receive implant and randomized in the study (as applicable).
Participant milestones
| Measure |
WaveWriter Settings
WaveWriter Programming
Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain.
|
Conventional Settings
Conventional Programming
Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
52
|
|
Overall Study
COMPLETED
|
41
|
48
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combining Mechanisms for Better Outcomes (COMBO)
Baseline characteristics by cohort
| Measure |
WaveWriter Settings
n=47 Participants
WaveWriter Programming
Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain.
|
Conventional Settings
n=52 Participants
Conventional Programming
Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.4 years
STANDARD_DEVIATION 12.23 • n=5 Participants
|
57.8 years
STANDARD_DEVIATION 12.09 • n=7 Participants
|
57.1 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black, of African Heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
47 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months post-randomizationPercentage of subjects with 50% or greater reduction from Baseline Visit in average overall pain intensity at 3 months post-randomization with no increase in opioid medications
Outcome measures
| Measure |
WaveWriter Settings
n=41 Participants
WaveWriter Programming
Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain.
|
Conventional Settings
n=48 Participants
Conventional Programming
Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain.
|
|---|---|---|
|
Overall Pain Responder Rate
|
36 Participants
|
34 Participants
|
Adverse Events
WaveWriter Settings
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Conventional Settings
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
WaveWriter Settings
n=41 participants at risk
WaveWriter Programming
Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain.
|
Conventional Settings
n=48 participants at risk
Conventional Programming
Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected up to end of randomized phase (3 months post-randomization)
Adverse Events including Serious Adverse Events were collected up to end of randomized phase (3 months post-randomization)
|
0.00%
0/48 • Adverse Events were collected up to end of randomized phase (3 months post-randomization)
Adverse Events including Serious Adverse Events were collected up to end of randomized phase (3 months post-randomization)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected up to end of randomized phase (3 months post-randomization)
Adverse Events including Serious Adverse Events were collected up to end of randomized phase (3 months post-randomization)
|
0.00%
0/48 • Adverse Events were collected up to end of randomized phase (3 months post-randomization)
Adverse Events including Serious Adverse Events were collected up to end of randomized phase (3 months post-randomization)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected up to end of randomized phase (3 months post-randomization)
Adverse Events including Serious Adverse Events were collected up to end of randomized phase (3 months post-randomization)
|
0.00%
0/48 • Adverse Events were collected up to end of randomized phase (3 months post-randomization)
Adverse Events including Serious Adverse Events were collected up to end of randomized phase (3 months post-randomization)
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected up to end of randomized phase (3 months post-randomization)
Adverse Events including Serious Adverse Events were collected up to end of randomized phase (3 months post-randomization)
|
0.00%
0/48 • Adverse Events were collected up to end of randomized phase (3 months post-randomization)
Adverse Events including Serious Adverse Events were collected up to end of randomized phase (3 months post-randomization)
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected up to end of randomized phase (3 months post-randomization)
Adverse Events including Serious Adverse Events were collected up to end of randomized phase (3 months post-randomization)
|
0.00%
0/48 • Adverse Events were collected up to end of randomized phase (3 months post-randomization)
Adverse Events including Serious Adverse Events were collected up to end of randomized phase (3 months post-randomization)
|
|
Metabolism and nutrition disorders
Obesity
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected up to end of randomized phase (3 months post-randomization)
Adverse Events including Serious Adverse Events were collected up to end of randomized phase (3 months post-randomization)
|
0.00%
0/48 • Adverse Events were collected up to end of randomized phase (3 months post-randomization)
Adverse Events including Serious Adverse Events were collected up to end of randomized phase (3 months post-randomization)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/41 • Adverse Events were collected up to end of randomized phase (3 months post-randomization)
Adverse Events including Serious Adverse Events were collected up to end of randomized phase (3 months post-randomization)
|
2.1%
1/48 • Number of events 1 • Adverse Events were collected up to end of randomized phase (3 months post-randomization)
Adverse Events including Serious Adverse Events were collected up to end of randomized phase (3 months post-randomization)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/41 • Adverse Events were collected up to end of randomized phase (3 months post-randomization)
Adverse Events including Serious Adverse Events were collected up to end of randomized phase (3 months post-randomization)
|
4.2%
2/48 • Number of events 2 • Adverse Events were collected up to end of randomized phase (3 months post-randomization)
Adverse Events including Serious Adverse Events were collected up to end of randomized phase (3 months post-randomization)
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.00%
0/41 • Adverse Events were collected up to end of randomized phase (3 months post-randomization)
Adverse Events including Serious Adverse Events were collected up to end of randomized phase (3 months post-randomization)
|
2.1%
1/48 • Number of events 1 • Adverse Events were collected up to end of randomized phase (3 months post-randomization)
Adverse Events including Serious Adverse Events were collected up to end of randomized phase (3 months post-randomization)
|
|
Nervous system disorders
Ischaemic Stroke
|
0.00%
0/41 • Adverse Events were collected up to end of randomized phase (3 months post-randomization)
Adverse Events including Serious Adverse Events were collected up to end of randomized phase (3 months post-randomization)
|
2.1%
1/48 • Number of events 1 • Adverse Events were collected up to end of randomized phase (3 months post-randomization)
Adverse Events including Serious Adverse Events were collected up to end of randomized phase (3 months post-randomization)
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place