Chronic Pain
Conditions
Keywords
Spinal Cord Stimulation
Brief summary
Study to evaluate the effectiveness of FAST-SCS (fast-acting paresthesia-free therapy) and additional SCS therapy options in patients with chronic pain using Boston Scientific WaveWriter SCS Systems.
Interventions
DEVICEBoston Scientific WaveWriter SCS System
WaveWriter SCS Programming
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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 (predominantly neuropathic) 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 when written informed consent is obtained * 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 or external factors 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 |
|---|---|---|
| Targeted Pain Responder Rate | 3 months post-activation | Proportion of subjects with 50% or greater reduction from Baseline Visit in average targeted pain intensity at 3 months post-activation |
Countries
United States
Contacts
STUDY_DIRECTORNatalie Bloom Lyons
Boston Scientific Corporation
Participant flow
Recruitment details
Only consented subjects who meet protocol criteria proceed to activation. The primary endpoint analysis is based on 20 activated subjects at 3-Month Visit. At the time of analysis, 104 provided informed consent, of which 62 were screen failures, 11 were withdrawn. Of the 31 remaining subjects 9 were pending evaluation, 2 had IPG activation and 20 had completed the 3-Month Visit. 73 additional subjects were consented before enrollment was complete. This accounts for the 177 subjects (104+73).
Participants by arm
| Arm | Count |
|---|---|
| WaveWriter Settings Boston Scientific WaveWriter SCS System: WaveWriter SCS Programming | 86 |
| Total | 86 |
Baseline characteristics
| Characteristic | WaveWriter Settings |
|---|---|
| Age, Continuous | 59.67 years STANDARD_DEVIATION 13.08 |
| Average overall pain (VRS) | 7.4 units on a scale STANDARD_DEVIATION 1.3 |
| Race/Ethnicity, Customized Race Black, of African heritage | 13 Participants |
| Race/Ethnicity, Customized Race Caucasian | 65 Participants |
| Race/Ethnicity, Customized Race Hispanic or Latino | 5 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Race Not disclosed | 2 Participants |
| Region of Enrollment United States | 86 participants |
| Sex/Gender, Customized Gender Female | 56 Participants |
| Sex/Gender, Customized Gender Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 104 |
| other Total, other adverse events | 6 / 104 |
| serious Total, serious adverse events | 6 / 104 |
Outcome results
Primary
Targeted Pain Responder Rate
Proportion of subjects with 50% or greater reduction from Baseline Visit in average targeted pain intensity at 3 months post-activation
Time frame: 3 months post-activation
Population: Interim analysis of 20 activated subjects at 3-Month Visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WaveWriter Settings | Targeted Pain Responder Rate | 16 Participants |