Chronic Pain
Conditions
Keywords
stimulation, chronic pain, back pain, leg pain
Brief summary
This is a prospective, multi-center, non-randomized, exploratory, single-arm study characterize the effects of programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial
Interventions
DEVICEProgramming
Programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Study candidate is undergoing a spinal cord stimulation (SCS) trial of BSC neurostimulation system, per local directions for use (DFU). * Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form. * Subject is 18 years of age or older when written informed consent is obtained. Key
Exclusion criteria
* Subject meets any contraindication in BSC neurostimulation system local directions for use (DFU).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Comfort | An estimated average of 7 days post temporary trial procedure | Number of participants reporting comfort level of stimulation sensation as Very Comfortable or Slightly Comfortable |
Countries
United States
Participant flow
Pre-assignment details
35 subjects were enrolled in and started the study. 2 were withdrawn prior to the Programming Visit. 33 started the Programming Visit and 32 completed the study. Statistically relevant conclusions cannot be made from this small sample size.
Participants by arm
| Arm | Count |
|---|---|
| Spinal Cord Stimulation Spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial
Programming: Programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Subject's failure to meet study inclusion or exclusion criteria after enrollment | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Spinal Cord Stimulation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 17 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 35 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 14 Participants |
| Work Status Disability | 6 participants |
| Work Status Employed | 8 participants |
| Work Status Not reported | 1 participants |
| Work Status Retired | 14 participants |
| Work Status Student | 1 participants |
| Work Status Unemployed | 6 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
Primary
Patient Comfort
Number of participants reporting comfort level of stimulation sensation as Very Comfortable or Slightly Comfortable
Time frame: An estimated average of 7 days post temporary trial procedure
Population: 32 subjects completing the Programming Visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Spinal Cord Stimulation | Patient Comfort | 30 Participants |