Chronic Pain
Conditions
Brief summary
To demonstrate sustained clinically significant pain relief in patients with chronic pain when using the Boston Scientific Precision Spinal Cord Stimulator (SCS) System at sub-perception amplitude
Detailed description
To demonstrate sustained clinically significant pain relief in patients when using the Boston Scientific Precision Spinal Cord Stimulator (SCS) System at sub-perception amplitude
Interventions
DEVICEPrecision or Precision Spectra Spinal Cord Stimulator System
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Complaint of chronic pain of the trunk and/or limbs 2. Willing and able to comply with all protocol-required procedures and assessments/evaluations; able to independently read and complete all questionnaires and assessments provided in English 3. Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form (ICF) provided in English Key
Exclusion criteria
1. Meets any contraindication in the Precision SCS system per locally applicable Directions for Use (DFU) 2. Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects With 50% or Greater Reduction in Overall Pain Intensity From Baseline | 90 days post activation | Proportion of subjects with 50% or greater reduction in overall pain intensity from baseline with supra and sub perception amplitude with no increase in average daily medication intake to treat pain |
Countries
United States
Participant flow
Recruitment details
Enrolled subjects underwent study eligibility to determine if they can continue in the study. Following completion of study eligibility, subjects were randomized to the cross-over phase.
Participants by arm
| Arm | Count |
|---|---|
| SCS Starting at Supra-perception Amplitude Precision or Precision Spectra Spinal Cord Stimulator System programmed starting at supra-perception and followed by sub-perception amplitude.
Precision or Precision Spectra Spinal Cord Stimulator System | 75 |
| SCS Starting at Sub-perception Amplitude Precision or Precision Spectra Spinal Cord Stimulator System starting at sub-perception and followed by supra-perception amplitude.
Precision or Precision Spectra Spinal Cord Stimulator System | 65 |
| Total | 140 |
Baseline characteristics
| Characteristic | SCS Starting at Supra-perception Amplitude | SCS Starting at Sub-perception Amplitude | Total |
|---|---|---|---|
| Age, Continuous | 60.7 years STANDARD_DEVIATION 11.9 | 58.8 years STANDARD_DEVIATION 10.7 | 59.8 years STANDARD_DEVIATION 11.3 |
| Sex: Female, Male Female | 44 Participants | 39 Participants | 83 Participants |
| Sex: Female, Male Male | 31 Participants | 26 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 140 | 0 / 140 | 0 / 140 |
| other Total, other adverse events | 0 / 140 | 0 / 140 | 0 / 140 |
| serious Total, serious adverse events | 7 / 140 | 3 / 140 | 4 / 140 |
Outcome results
Primary
Proportion of Subjects With 50% or Greater Reduction in Overall Pain Intensity From Baseline
Proportion of subjects with 50% or greater reduction in overall pain intensity from baseline with supra and sub perception amplitude with no increase in average daily medication intake to treat pain
Time frame: 90 days post activation
Population: Due to the nature of crossover study design, all subjects contributed towards each arm, as reflected in the number of participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SCS With Supra-perception Amplitude | Proportion of Subjects With 50% or Greater Reduction in Overall Pain Intensity From Baseline | 32 Participants |
| SCS With Sub-perception Amplitude | Proportion of Subjects With 50% or Greater Reduction in Overall Pain Intensity From Baseline | 41 Participants |