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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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).
South Bend Orthopaedics
Mishawaka, Indiana, United States
RECRUITINGUniversity of Minnesota
Minneapolis, Minnesota, United States
RECRUITINGPrimary Safety Endpoint: Characterization of device-related adverse events
Time frame: Surgery through 12 months post-op
Primary Effectiveness Endpoint: Change in back and leg pain Visual Analog Score (VAS) scores
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.
Time frame: Baseline to 3 months post-op
Change in neurological status
Change in neurological status measured by the neurological component of the standard physical exam.
Time frame: Baseline to 3, 6, and 12 months post-op
Change in disability measured by the Oswestry Disability Index (ODI).
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.
Time frame: Baseline to 3, 6, and 12 months post-op
Change in quality of life as measured by PROMIS Scale v1.2 - Global Health.
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.
Time frame: Baseline to 3, 6, and 12 months post-op
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change in quality of life as measured by EQ-5D-5L.
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.
Time frame: Baseline to 3, 6, and 12 months post-op
Change in use of analgesics over time
Change in use of medications at all follow up visits.
Time frame: Baseline through 12 months post-op