Back Pain, Chronic Pain
Conditions
Keywords
Chronic Pain, Back Pain, Leg Pain, Pain, Stimulation, Spinal Cord Stimulator, Implantable Pulse Generator
Brief summary
To demonstrate the value of multiple modalities and sustained clinically significant pain relief in patients with chronic pain when using the Boston Scientific Spectra WaveWriter Spinal Cord Stimulator (SCS) System.
Interventions
DEVICESpectra WaveWriter SCS System
Multiple modalities of stimulation therapy
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 of the trunk and/or limbs * 22 years of age or older at time of enrollment * Willing and able to comply with all protocol-required procedures and assessments/evaluations provided in English * Willing and capable of giving informed consent 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 * Current systemic infection, or local infection in close proximity to the anticipated surgical field * Breast-feeding, pregnant or planning to get pregnant during the course of the study or not using adequate contraception * Previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator) * 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 |
|---|---|
| Percentage of Subjects With 50% or Greater Reduction in Overall Pain From Baseline | 3 months post activation |
Countries
United States
Participant flow
Recruitment details
Subjects were considered enrolled once informed consent was completed. Only those who met all eligibility criteria went on to receive implant and proceed in the study.
Participants by arm
| Arm | Count |
|---|---|
| Spinal Cord Stimulation Spectra WaveWriter SCS System
Spectra WaveWriter SCS System: Multiple modalities of stimulation therapy | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Spinal Cord Stimulation |
|---|---|
| Age, Continuous | 63.2 years STANDARD_DEVIATION 12 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 40 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 97 |
| other Total, other adverse events | 0 / 97 |
| serious Total, serious adverse events | 7 / 97 |
Outcome results
Primary
Percentage of Subjects With 50% or Greater Reduction in Overall Pain From Baseline
Time frame: 3 months post activation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Spinal Cord Stimulation | Percentage of Subjects With 50% or Greater Reduction in Overall Pain From Baseline | 31 Participants |