Chronic Pain
Conditions
Keywords
Spinal Cord Stimulation, Chronic Pain
Brief summary
The primary objective of this study is to characterize the real-world outcomes of spinal cord stimulation (SCS) therapy as an aid in the management of chronic intractable pain of the trunk, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain using the Boston Scientific (BSC) PRECISION Spinal Cord Stimulator System with MultiWave Technology.
Detailed description
The purpose of this study is to characterize the real-world outcomes of spinal cord stimulation (SCS) therapy as an aid in the management of chronic intractable pain of the trunk, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain using the Boston Scientific (BSC) PRECISION Spinal Cord Stimulator System with MultiWave Technology.
Interventions
Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Complaint of persistent or recurrent low back pain for at least 180 days prior to Screening * Willing and able to comply with all protocol-required procedures and assessments/evaluations * Subject signed a valid, ethics committee (EC)-approved informed consent form (ICF) provided in local language Key
Exclusion criteria
* High surgical risk * Previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator) * A female who is pregnant, is breastfeeding, or is of childbearing potential and planning to get pregnant during the course of the study or not using adequate contraception. * Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study * Any diagnosis or condition that, in the clinician's best judgment, might confound reporting of study outcomes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Low Back Pain Responders | 3 months | Percentage of low back pain responders at 3 months post-activation with no increase in opioids from Baseline to 3 months post-activation |
Countries
Germany, Italy, Netherlands, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Spinal Cord Stimulation (SCS) System Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology
Spinal Cord Stimulation (SCS) System: Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology | 59 |
| Total | 59 |
Baseline characteristics
| Characteristic | Spinal Cord Stimulation (SCS) System | — |
|---|---|---|
| Age, Continuous | 56.8 years STANDARD_DEVIATION 13.7 | — |
| Average Low Back Pain Scores (NRS) | 7.4 units on a scale STANDARD_DEVIATION 1.5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 42 Participants | — |
| Sex: Female, Male Male | 17 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 73 |
| other Total, other adverse events | 4 / 73 |
| serious Total, serious adverse events | 6 / 73 |
Outcome results
Primary
Percentage of Low Back Pain Responders
Percentage of low back pain responders at 3 months post-activation with no increase in opioids from Baseline to 3 months post-activation
Time frame: 3 months
Population: For All subjects without outlier sites, data for those sites with outlier subjects were removed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spinal Cord Stimulation (SCS) System | Percentage of Low Back Pain Responders | All Subjects | 25 Participants |
| Spinal Cord Stimulation (SCS) System | Percentage of Low Back Pain Responders | All subjects without outliers | 23 Participants |