Chronic Pain, Radiculopathy Lumbar, Spinal Fusion
Conditions
Keywords
Dorsal Root Ganglion, Neurostimulation, Failed Back Surgery Syndrome
Brief summary
The purpose of the study is to evaluate the safety and tolerability of DRG stimulation when placing a neurostimulator during the same procedure as implantation of spinal fixation with or without interbody cage systems in patients with chronic back and/or leg pain requiring single level spinal fusion.
Interventions
DEVICEDRG Neurostimulation with Spinal Fusion
Surgeons will implant a neurostimulator during the same open back procedure as fusion devices (spinal fusion hardware and interbody cage) and begin neurostimulation in a short time following surgery (24 hours).
Sponsors
SynerFuse, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single group
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Indicated for a single level or two level adjacent spinal fusion having back pain and radiculopathy * Have been diagnosed with chronic, intractable pain of the lower back and/or leg refractory to conservative therapy for at least 3 of months * At least 6 months since last surgical procedure on the spine * Be 21 years of age or older at the time of enrollment * Be willing and capable of giving informed consent * Be willing and able to comply with study-related requirements
Exclusion criteria
* Any prior spinal fusion at index or adjacent level * Pregnant * Have a life expectancy of less than 1 year * Be concomitantly participating in another clinical study * Be involved in an injury claim under current litigation * Baseline narcotic use of ≥ 100 MME per day * Significant untreated addiction to dependency producing medications * Current active implantable medical device * Cancer * Have osteoporosis * Active infection * Allergies to system components * AGE \> 80 * Expected need to undergo MRI imaging in the future * Other significant comorbidities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Endpoint: Change in back and leg pain Visual Analog Score (VAS) scores | Baseline to 3 months post-op | VAS scores range from 0 (no pain) to 100 (pain is as bad as it could possibly be). Decreases in scores indicate reductions in pain. |
| Primary Safety Endpoint: Characterization of device-related adverse events | Surgery through 12 months post-op | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in disability measured by the Oswestry Disability Index (ODI). | Baseline to 3, 6, and 12 months post-op | Each question is scored from 0-5. The scores from each question are summed, then divided by the maximum number possible, then multiplied by 100 to represent a percentage. The percentages are broken down into 5 category ranges: 0% to 20%: minimal disability, 21%-40%: moderate disability; 41%-60%: severe disability; 61%-80%: crippled; 80%-100%: bed-bound or exagerating. |
| Change in quality of life as measured by EQ-5D-5L. | Baseline to 3, 6, and 12 months post-op | The EQ-5D-5L survey consists of 5 dimensions with the score for each ranging from 1 (no problems) to 5 (unable to do). For individual dimensions, negative changes (e.g. from 5 to 3) indicate improvement. The scores on these five dimensions will be presented as a health profile and converted to a single summary index number (utility). Positive changes in the total score indicate improvement. |
| Change in use of analgesics over time | Baseline through 12 months post-op | Change in use of medications at all follow up visits. |
| Change in quality of life as measured by PROMIS Scale v1.2 - Global Health. | Baseline to 3, 6, and 12 months post-op | The is a 10-item patient-reported questionnaire in which the response options are presented as a 5-point rating scale. The results of the scores are are used to calculate two summary scores: a Global Physical Health score and a Global Mental Health score. These scores are then standardized to the general population, using the T-Score. The average T-Score for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient. |
| Change in neurological status | Baseline to 3, 6, and 12 months post-op | Change in neurological status measured by the neurological component of the standard physical exam. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Amount of device migration | Surgery to 3, 6, and 12 months post-op | Amount of device migration as measured by anteroposterior (AP) and lateral x-rays. |
| Costs and cost-effectiveness of the intervention | Baseline through 12 months post-op | The cost effectiveness analysis will report total healthcare-related expenditures reported by patients from baseline to 12 months post-op and 12 month quality-adjusted life-years (QALYs). Incremental cost per QALY will be estimated and compared to previously published studies. |
Countries
United States
Contacts
Primary ContactGabi Molnar
Outcome results
None listed