Pain, Chronic
Conditions
Brief summary
The objective of the study is to characterize the relationship between select objective metrics and clinical outcomes in chronic pain patients treated with Boston Scientific commercially approved neurostimulation systems.
Interventions
DEVICENeurostimulation System
Spinal cord stimulation
Sponsors
Boston Scientific Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: \- Is willing and able to comply with completing protocol required assessments and evaluations Key
Exclusion criteria
\- Has any pain-related diagnosis, medical/psychological condition or external factors that, in the investigator's medical judgment, might confound reporting of study outcomes (e.g. history of pelvic pain, anginal pain, chronic migraine, involved in litigation, workmen's compensation)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Responder Rate | 12 months | Proportion of subjects with 50% or greater reduction in Low Back pain |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study Patients enrolled in the ENVISION study. Follow-up period is based on date they signed the informed consent and were enrolled into the study.
All commercially approved Boston Scientific neurostimulation systems indicated for the treatment of chronic pain, except for Precision™ and Precision™ Plus.
Neurostimulation System: Spinal cord stimulation | 359 |
| Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 SCS Trial Procedure) Navitas Study Patients enrolled in the NAVITAS study. Follow-up period is based on date of their SCS Trial Procedure.
All commercially approved Boston Scientific neurostimulation systems indicated for the treatment of chronic pain.
Neurostimulation System: Spinal cord stimulation | 149 |
| Boston Scientific SCS Systems (Day 0 Implantable Pulse Generator (IPG) Activation) Navitas Study Patients enrolled in the NAVITAS study. Follow-up period is based on date of their Implantable Pulse Generator (IPG) was activated.
All commercially approved Boston Scientific neurostimulation systems indicated for the treatment of chronic pain.
Neurostimulation System: Spinal cord stimulation | 31 |
| Total | 539 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 5 | 4 | 0 |
| Overall Study | Attempted to implant study device but unable to do so/unsuccessful neurostimulation trial procedure | 14 | 3 | 0 |
| Overall Study | Closure of study | 55 | 3 | 0 |
| Overall Study | Death | 3 | 0 | 0 |
| Overall Study | Device Deficiency | 1 | 0 | 0 |
| Overall Study | Did not meet eligibility criteria | 0 | 6 | 0 |
| Overall Study | End of study information not provided to determine reason for withdrawal. | 0 | 1 | 1 |
| Overall Study | Lost to Follow-up | 9 | 4 | 0 |
| Overall Study | No longer meets protocol criteria | 12 | 7 | 0 |
| Overall Study | Other, additional details not available. | 0 | 12 | 1 |
| Overall Study | Physician Decision | 3 | 2 | 0 |
| Overall Study | Subject non-compliance | 23 | 2 | 1 |
| Overall Study | Withdrawal by Subject | 60 | 52 | 7 |
Baseline characteristics
| Characteristic | Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study | Total | Boston Scientific SCS Systems (Day 0 Implantable Pulse Generator (IPG) Activation) Navitas Study | Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 SCS Trial Procedure) Navitas Study |
|---|---|---|---|---|
| Age, Customized Age | 61.2 years STANDARD_DEVIATION 11.7 | 60.3 years STANDARD_DEVIATION 11.9 | 60.1 years STANDARD_DEVIATION 10.4 | 58.6 years STANDARD_DEVIATION 12.5 |
| Overall Pain Numeric Rating Scale (NRS) at Baseline | 5.9 units on a scale STANDARD_DEVIATION 2.3 | 6.5 units on a scale STANDARD_DEVIATION 2.2 | 7.3 units on a scale STANDARD_DEVIATION 1.4 | 7.6 units on a scale STANDARD_DEVIATION 1.6 |
| Race/Ethnicity, Customized American Indian or Alaska native | 2 Participants | 5 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black, of African heritage | 19 Participants | 38 Participants | 5 Participants | 14 Participants |
| Race/Ethnicity, Customized Caucasian | 261 Participants | 406 Participants | 25 Participants | 120 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 15 Participants | 23 Participants | 0 Participants | 8 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not disclosed | 6 Participants | 13 Participants | 0 Participants | 7 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 359 Participants | 539 Participants | 31 Participants | 149 Participants |
| Sex: Female, Male Female | 181 Participants | 296 Participants | 18 Participants | 97 Participants |
| Sex: Female, Male Male | 117 Participants | 182 Participants | 13 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 363 | 0 / 150 | 0 / 31 |
| other Total, other adverse events | 0 / 363 | 0 / 150 | 2 / 31 |
| serious Total, serious adverse events | 51 / 363 | 16 / 150 | 12 / 31 |
Outcome results
Primary
Pain Responder Rate
Proportion of subjects with 50% or greater reduction in Low Back pain
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Boston Scientific SCS Systems (Day 0 Enrollment) | Pain Responder Rate | 158 Participants |
| Boston Scientific SCS Systems (Day 0 SCS Trial Procedure) | Pain Responder Rate | 49 Participants |
| Boston Scientific SCS Systems (Day 0 IPG Activation) | Pain Responder Rate | 21 Participants |