Chronic Pain
Conditions
Keywords
Spinal Cord Stimulation
Brief summary
To evaluate the safety and effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities compared to Conventional Medical Management (CMM) in patients with chronic low back and/or leg pain who have not undergone spinal surgery when using the Boston Scientific WaveWriter SCS Systems.
Interventions
DEVICEWaveWriter
To receive Spinal Cord Stimulation programming
OTHERConventional Medical Managament
To receive conventional medical management
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Chronic low back pain, with or without leg pain, for at least 6 months * Received at least 90 days of documented pain management care to address the primary pain complaint, prior to Screening (e.g. medication, physical therapy) * If female of childbearing potential: not pregnant, as evidenced by a negative pregnancy test at Screening * Subject signed a valid, IRB-approved informed consent form (ICF) provided in English Key
Exclusion criteria
* Primary pain complaint of vascular origin (e.g. peripheral vascular disease) * Require implantation of lead(s) in the cervical epidural space * Significant cognitive impairment at Screening that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to assess pain intensity * Previous failed spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder Rate | 3 months post-activation | Proportion of subjects with 50% or greater reduction in overall pain relief |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Disability (Oswestry Disability Index) | 3-Months post activation | Change in Disability (Oswestry Disability Index). The Oswestry Disability Index (ODI) is a validated questionnaire of pain-related disability with total score on a scale of 0 (no disability) to 100 (complete disability). Categories for ODI total score are 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). The published minimally clinically important difference for change in ODI is 10 points. |
Countries
United States
Participant flow
Recruitment details
241 subjects provided informed consent.
Pre-assignment details
After subjects were consented and enrolled, they were evaluated per study eligibility criteria. Only those who met criteria proceeded to randomization.
Participants by arm
| Arm | Count |
|---|---|
| Randomized to Spinal Cord Stimulation (SCS) Treatment Activated Baseline demographics and clinical characteristics for subjects in the SCS arm | 79 |
| Randomized to Conventional Medical Management (CMM) Treatment Activated Baseline demographics and clinical characteristics for subjects in the CMM arm | 68 |
| Total | 147 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 1 | 0 |
| Overall Study | Physician Decision | 2 | 0 | 1 |
| Overall Study | Screen Failure/ | 1 | 1 | 85 |
| Overall Study | Various reasons (moved, no longer meets criteria, visit not done etc.) | 7 | 1 | 1 |
| Overall Study | Will not move forward with permanent implant | 6 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 1 | 6 |
Baseline characteristics
| Characteristic | Randomized to Spinal Cord Stimulation (SCS) Treatment Activated | Randomized to Conventional Medical Management (CMM) Treatment Activated | Total |
|---|---|---|---|
| Age, Continuous | 57.3 years STANDARD_DEVIATION 12.1 | 61.0 years STANDARD_DEVIATION 11.9 | 59.0 years STANDARD_DEVIATION 12.1 |
| Average low back pain (VRS) | 7.5 units on a scale STANDARD_DEVIATION 1 | 7.6 units on a scale STANDARD_DEVIATION 0.9 | 7.6 units on a scale STANDARD_DEVIATION 0.9 |
| Average overall pain (VRS) | 7.5 units on a scale STANDARD_DEVIATION 0.9 | 7.5 units on a scale STANDARD_DEVIATION 1 | 7.5 units on a scale STANDARD_DEVIATION 0.9 |
| Duration of Low Back Pain | 11.5 years STANDARD_DEVIATION 10.4 | 12.9 years STANDARD_DEVIATION 11.5 | 12.2 years STANDARD_DEVIATION 10.9 |
| Oswestry Disability Index (ODI) Summary Score | 54.4 units on a scale STANDARD_DEVIATION 8.5 | 54.4 units on a scale STANDARD_DEVIATION 9.4 | 54.4 units on a scale STANDARD_DEVIATION 8.9 |
| Race/Ethnicity, Customized Race and Ethnicity : American Indian or Alaska native | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race and Ethnicity : Black, of African heritage | 6 Participants | 3 Participants | 9 Participants |
| Race/Ethnicity, Customized Race and Ethnicity : Caucasian | 72 Participants | 62 Participants | 134 Participants |
| Race/Ethnicity, Customized Race and Ethnicity : Hispanic or Latino | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Race and Ethnicity : Not disclosed | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 79 participants | 68 participants | 147 participants |
| Sex: Female, Male Female | 55 Participants | 43 Participants | 98 Participants |
| Sex: Female, Male Male | 24 Participants | 25 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 79 | 1 / 68 |
| other Total, other adverse events | 9 / 79 | 4 / 68 |
| serious Total, serious adverse events | 8 / 79 | 1 / 68 |
Outcome results
Primary
Responder Rate
Proportion of subjects with 50% or greater reduction in overall pain relief
Time frame: 3 months post-activation
Population: Intent to Treat population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Spinal Cord Stimulation | Responder Rate | 51 Participants |
| Conventional Medical Management | Responder Rate | 5 Participants |
Secondary
Change in Disability (Oswestry Disability Index)
Change in Disability (Oswestry Disability Index). The Oswestry Disability Index (ODI) is a validated questionnaire of pain-related disability with total score on a scale of 0 (no disability) to 100 (complete disability). Categories for ODI total score are 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). The published minimally clinically important difference for change in ODI is 10 points.
Time frame: 3-Months post activation
Population: Intent to treat population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Cord Stimulation | Change in Disability (Oswestry Disability Index) | -27.5 score on a scale | Standard Deviation 15.9 |
| Conventional Medical Management | Change in Disability (Oswestry Disability Index) | -7.2 score on a scale | Standard Deviation 9.9 |