Back Pain, Chronic Pain
Conditions
Brief summary
To evaluate the effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities as compared to conventional SCS in patients with chronic pain when using the Boston Scientific Spectra WaveWriter SCS System.
Detailed description
To evaluate the effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities as compared to conventional SCS in patients with chronic pain when using the Boston Scientific Spectra WaveWriter SCS System.
Interventions
DEVICEBoston 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.
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 pain of the trunk and/or limbs for at least 6 months with back pain greater or equal to leg pain. * 22 years of age or older at time of enrollment * Able to independently read and complete all questionnaires and assessments provided in English * Signed a valid, IRB-approved informed consent form (ICF) provided in English Key
Exclusion criteria
* Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes * Significant cognitive impairment that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study * Breast-feeding or planning to get pregnant during the course of the study or not using adequate contraception * Participating, or intends to participate, in another clinical trial that may influence the data that will be collected for this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Pain Responder Rate | 3 months post-randomization | 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 |
Countries
United States
Participant flow
Recruitment 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 |
|---|---|
| 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. | 47 |
| 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. | 52 |
| Total | 99 |
Baseline characteristics
| Characteristic | WaveWriter Settings | Conventional Settings | Total |
|---|---|---|---|
| Age, Continuous | 56.4 years STANDARD_DEVIATION 12.23 | 57.8 years STANDARD_DEVIATION 12.09 | 57.1 years STANDARD_DEVIATION 12.1 |
| Race/Ethnicity, Customized Black, of African Heritage | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 47 Participants | 49 Participants | 96 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Female | 30 Participants | 36 Participants | 66 Participants |
| Sex: Female, Male Male | 17 Participants | 16 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 48 |
| other Total, other adverse events | 0 / 41 | 0 / 48 |
| serious Total, serious adverse events | 4 / 41 | 5 / 48 |
Outcome results
Primary
Overall Pain Responder Rate
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
Time frame: 3 months post-randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WaveWriter Settings | Overall Pain Responder Rate | 36 Participants |
| Conventional Settings | Overall Pain Responder Rate | 34 Participants |