Back Pain, Chronic Pain, Pain in Leg, Unspecified
Conditions
Keywords
Pain, Neurostimulation, Leg Pain, Back Pain
Brief summary
The primary objective of this study is to evaluate the acute and chronic efficacy of spinal cord stimulation using the Precision implantable neurostimulation device with the Artisan paddle electrode in patients with Failed Back Surgery Syndrome (FBSS) and associated primary or secondary back or lower extremity pain. There are significant numbers of patients with FBSS who have moderate to severe drug refractory pain. An optimal outcome will demonstrate that the Precision SCS device has significant effectiveness in reducing this pain resulting in improved quality of life and functional capacity.
Detailed description
The conventional implantation of the spinal cord stimulator calls for dual percutaneous leads placed in parallel at T8-T9 vertebral levels. A common problem after surgery is the migration of leads from the initial implanted site, the consequence of which is inadequate pain relief. Anecdotal reports suggest that the paddle electrode can eliminate some of the problems associated with lead migration by providing a constant distance between the parallel electrodes. Furthermore, it has been reported to provide superior pain relief and paresthesia coverage. This study aims to evaluate pain and paresthesia coverage by placing a paddle lead. Patients invited to participate in this study 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
DEVICEArtisan Surgical Lead
Artisan paddle electrode is a 2 x 8 surgical lead approved for use as part of the Precision System.
Precision System aids in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable back pain, and leg pain.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have FBSS with moderate to severe back or lower extremity pain of at least 3 months duration, be an appropriate candidate for SCS, and have independently elected SCS therapy with the Precision system as next line therapy; * 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 low back pain as the primary complaint; * Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints; * Have participated in any investigational drug or device trial in the last 4 weeks or plan to participate in any other study during the year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in Baseline Back Pain Severity as Measured at 3 Months Post-activation | 3 months post-activation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Precision Spinal Cord Stimulation Single arm Precision Spinal Cord Stimulation System with Artisan Surgical Lead
Precision Spinal Cord Stimulation System: Precision System aids in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable back pain, and leg pain.
Artisan Surgical Lead: Artisan paddle electrode is a 2 x 8 surgical lead approved for use as part of the Precision System. | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Precision Spinal Cord Stimulation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 1 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Reduction in Baseline Back Pain Severity as Measured at 3 Months Post-activation
Time frame: 3 months post-activation
Population: The study was terminated and efforts were made to locate data. No study data are available.