Back Pain, Chronic Pain
Conditions
Brief summary
To evaluate the safety and effectiveness of the Precision Spinal Cord Stimulator Systems Adapted for High-Rate Spinal Cord Stimulation as an aid in the management of chronic intractable pain
Detailed description
To evaluate the safety and effectiveness of high rate spinal cord stimulation (HR-SCS) therapy as an aid in the management of chronic intractable pain of the trunk using the Boston Scientific (BSC) PRECISION Spinal Cord Stimulator Systems Adapted for High-Rate Spinal Cord Stimulation
Interventions
DEVICEPRECISION SCS Adapted for High-Rate SCS
Comparison of spinal cord stimulation parameters
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have been diagnosed with chronic, intractable pain of the trunk (NRS ≥ 5) which has been refractory to conservative therapy for a minimum of 90 days. * Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician * Be 22 years of age or older at the time of enrollment * Be willing and capable of giving informed consent * Be willing and able to comply with study-related requirements, procedures, and visits
Exclusion criteria
* Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator * Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome, as determined by a psychologist * Have previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator) * Have a current systemic infection, or local infection in close proximity to anticipated surgical field * Pregnant or plan to get pregnant during the course of the study or not using adequate contraception. * Be participating in another clinical study that may influence the data collected for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Responders as Determined by the Cumulative Distribution Function (CDF) of Response Rates | 3 months post-activation | Cummulative distribution function (CDF) of response rates from 0% - 100% numerical rating score (NRS) to derive the entire range of possible responder definitions. This allows us to determine the range of success for all responder rates without the need to identify a certain cutoff (for example, use a 50% responder rate). A comparison between the two CDF's was performed by comparing the area under the curves since area between CDFs is equal to the mean difference in low back pain reduction for CR-SCS and HR-SCS. Hence, it can be used to estimate the true underlying difference in responder rates between CR-SCS and HR-SCS |
Countries
United States
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| High Rate SCS Followed by Commercial SCS High Rate SCS Settings followed by Commercial Settings | 98 |
| Commercial SCS Settings Followed by High Rate SCS Commercial SCS Settings followed by High Rate SCS programming settings | 90 |
| High Rate Settings Only High Rate settings only | 68 |
| Total | 256 |
Baseline characteristics
| Characteristic | High Rate SCS Followed by Commercial SCS | Commercial SCS Settings Followed by High Rate SCS | High Rate Settings Only | Total |
|---|---|---|---|---|
| Age, Continuous | 54.9 years STANDARD_DEVIATION 11.6 | 53.6 years STANDARD_DEVIATION 13.1 | 58.5 years STANDARD_DEVIATION 11.4 | 55.6 years STANDARD_DEVIATION 12 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 3 Participants | 7 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 6 Participants | 3 Participants | 15 Participants |
| Race (NIH/OMB) White | 83 Participants | 76 Participants | 57 Participants | 216 Participants |
| Sex: Female, Male Female | 59 Participants | 49 Participants | 27 Participants | 135 Participants |
| Sex: Female, Male Male | 39 Participants | 41 Participants | 41 Participants | 121 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 188 | 0 / 188 | 0 / 68 |
| other Total, other adverse events | 11 / 188 | 13 / 188 | 4 / 68 |
| serious Total, serious adverse events | 8 / 188 | 3 / 188 | 2 / 68 |
Outcome results
Primary
Proportion of Responders as Determined by the Cumulative Distribution Function (CDF) of Response Rates
Cummulative distribution function (CDF) of response rates from 0% - 100% numerical rating score (NRS) to derive the entire range of possible responder definitions. This allows us to determine the range of success for all responder rates without the need to identify a certain cutoff (for example, use a 50% responder rate). A comparison between the two CDF's was performed by comparing the area under the curves since area between CDFs is equal to the mean difference in low back pain reduction for CR-SCS and HR-SCS. Hence, it can be used to estimate the true underlying difference in responder rates between CR-SCS and HR-SCS
Time frame: 3 months post-activation
Population: Subjects with a successful trial (High rate settings only) or simulated trial responders (High rate SCS followed by Commercial SCS or vice versa)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Commercial SCS | Proportion of Responders as Determined by the Cumulative Distribution Function (CDF) of Response Rates | 0.47 probability |
| High Rate SCS | Proportion of Responders as Determined by the Cumulative Distribution Function (CDF) of Response Rates | 0.53 probability |
| High Rate Settings Only | Proportion of Responders as Determined by the Cumulative Distribution Function (CDF) of Response Rates | 0.4 probability |