Back Pain, Chronic Pain, Pain
Conditions
Keywords
Pain, Neurostimulation, Back pain, Chronic Pain
Brief summary
The primary objective of this study is to assess the effects of varying pulse width in suprathreshold dorsal column stimulation in patients with low back pain.
Detailed description
This study will generate data which may allow Precision SCS devices to be used or programmed in such a way as to relieve pain while minimizing any uncomfortable sensations. This study will extend anecdotal reports into a prospective analysis of outcome data. Patients invited to participate in this study will have recently been implanted with the Precision system, or will be eligible for SCS therapy and will have already selected therapy with the Advanced Bionics Precision system, independent of possible inclusion in this study.
Interventions
DEVICEPrecision
Sponsors
Boston Scientific Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have chronic low back pain following spine surgery (Failed Back Surgery Syndrome), which is primarily located in the low back, with minimal lower extremity pain. * Have been permanently implanted with a Precision spinal cord stimulation (SCS) system within 6 months, or be an appropriate candidate for SCS and for the surgical procedures required for SCS as determined by the physician and have independently selected SCS with Precision for treatment. * Be 18 years of age or older. * Be willing and able to comply with all study related procedures and visits. * Be capable of reading and understanding patient information materials and giving written informed consent.
Exclusion criteria
* Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints. * Have any other chronic pain condition likely to confound evaluation of study endpoints.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Severity, as Measured on the 11-point (0-10) Numerical Rating Scale (NRS) | Within 6 months post-implantation | Pain severity as measured by NRS quantifies pain, where 0 is no pain and 10 is worst pain imaginable |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Spinal Cord Stimulation Programming Parameters Spinal Cord Stimulation (SCS) Treatment Group | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Spinal Cord Stimulation Programming Parameters |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Age Continuous | 53.4 years STANDARD_DEVIATION 12.9 |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
Primary
Pain Severity, as Measured on the 11-point (0-10) Numerical Rating Scale (NRS)
Pain severity as measured by NRS quantifies pain, where 0 is no pain and 10 is worst pain imaginable
Time frame: Within 6 months post-implantation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Cord Stimulation Programming Parameters | Pain Severity, as Measured on the 11-point (0-10) Numerical Rating Scale (NRS) | -56.1 Percent Change in Pain Rating | Standard Deviation 25.8 |