The Effect of Pulse Width on the Treatment of Chronic Low Back Pain With Spinal Cord Stimulation
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Pain Severity, as Measured on the 11-point (0-10) Numerical Rating Scale (NRS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Pain Severity, as Measured on the 11-point (0-10) Numerical Rating Scale (NRS)
Time Frame: Within 6 months post-implantation
Pain severity as measured by NRS quantifies pain, where 0 is "no pain" and 10 is "worst pain imaginable"
Secondary Outcomes
No secondary outcomes reported