Back Pain, Intractable Neuropathic Pain, Lower Extremity Pain, Pain
Conditions
Keywords
Pain, Chronic Pain, Neurostimulation
Brief summary
The primary objective of this study is to compare the efficacy and patient preference for spinal cord stimulation (SCS) using the Precision device with the electrode array placed at T7 versus placement at T8. Eligible patients will have chronic intractable pain in the back or lower extremities and will have independently elected SCS as the next line of therapy. There is some anecdotal evidence that the coverage of the paresthesia resulting from T7 placement is preferable to that obtained by the more commonly used T8 placement but there has been no study to support this observation.
Detailed description
The conventional implantation of the spinal cord stimulator calls for dual percutaneous leads placed at T8-T9 vertebral levels. Recently published studies as outlined in a letter to the editor of Neuromodulation suggest that a well placed single lead will generally perform better than a dual lead. Furthermore, anecdotal reports suggest that lead placement at T7 will capture axial back pain with greater success compared to lead placement at alternative sites. This study aims to achieve better pain treatment and paresthesia coverage by placing a single lead at T7.
Interventions
During Trial Implant Period, stimulation from single lead initially turned on at the T7 or T8 level, then crossover. At time of permanent implant, subject chooses which level they want the stimulator turned on.
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be diagnosed with chronic intractable neuropathic pain of moderate to severe intensity of the back or lower extremity and meeting the criteria for post-laminectomy syndrome, be eligible for SCS, and have independently elected SCS as next line of 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 sensory loss in the low back or lower extremity 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 |
|---|---|
| The Primary Efficacy Endpoint is Pain Severity After Trial Stimulation. | End of trial (approximately 5 days) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Baseline Enrolled subjects | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | Baseline |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Region of Enrollment United States | 13 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 13 |
| other Total, other adverse events | 0 / 13 |
| serious Total, serious adverse events | 2 / 13 |
Outcome results
Primary
The Primary Efficacy Endpoint is Pain Severity After Trial Stimulation.
Time frame: End of trial (approximately 5 days)
Population: The study was terminated and efforts were made to locate data. No study data are available