Dorsal spInal cord STImulatioN vs mediCal management for the Treatment of low back pain

Overview

About this study

The purpose of this study is to evaluate the effectiveness of BurstDRTM spinal cord stimulation, compared with comprehensive medical management, in improving pain and back-related physical function in patients suffering with chronic, refractory axial low back pain with a neuropathic component, who have not had lumbar spine surgery and for whom surgery is not an option.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Patient must be willing and able to provide written informed consent prior to any clinical investigation-related procedure.
  • Age ≥ 18 years.
  • Patient has chronic (at least 6 months), refractory axial low back pain with a neuropathic component and is not a candidate for spine surgery.
  • Patient has back pain for ≥ 6 months inadequately responsive to supervised conservative care.
  • Patient has not had spine surgery for back or leg pain.
  • Patient is a candidate for spinal cord stimulation.
  • Low back pain ≥ 6 on Numerical Rating Scale.
  • Oswestry Disability Index score of ≥ 30%.
  • Willing and able to comply with the instructions for use, operate the study device, and comply with this Clinical Investigation Plan.

Exclusion Criteria:

  • Pathology seen on imaging tests obtained within the past 12 months that is clearly identified and is likely the cause of the CLBP, that can be addressed with surgery.
  • Primary complaint of leg pain, or leg pain is greater than back pain.
  • Back pain is due to any of the following:
    • spinal instability defined as > 2 mm translation on radiographic imaging;
    • visceral causes (e.g., endometriosis or fibroids);
    • vascular causes (e.g., aortic aneurysm);
    • spinal infection (e.g., osteomyelitis);
    • inflammation or damage to the spinal cord (e.g., arachnoiditis or syringomyelia);
    • tumor or spinal metastases.
  • Has widespread pain (e.g., fibromyalgia) or pain in other area(s), not intended to be treated in this study (e.g., neck pain, shoulder pain).
  • Patient has seronegative spondyloarthropathy (e.g., rheumatoid, lupus, psoriatic).
  • Neurological deficit (e.g., foot drop).
  • Prior lumbar spine surgery or sacroiliac joint fusion.
  • Patient has used a morphine equivalent daily dose of more than 50 MEQ at any time in the last 90 days (3 months).
  • Patient is bed bound.
  • Patients with regular intake of systemic steroids (except inhaled steroids used to treat asthma).
  • Imaging (MRI, CT, X-ray) findings within the last 12 months that contraindicates lead placement.
  • Known allergic reaction to implanted materials.
  • Severe scoliotic deformity (> 11 degrees in thoracic or lumbar spine).
  • Patient has a history of, or existing intrathecal drug pump.
  • Patient has previous experience with neuromodulation devices, including a failed trial.
  • BMI > 40.
  • Patient is enrolled, or intends to participate, in another clinical drug and/or device study or registry that may interfere with the results of this study, as determined by Abbott personnel.
  • Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator’s opinion, could limit the subject’s ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results.
  • Failed psychological evaluation.
  • Evidence of untreated mental illness, or substance abuse.
  • Patient demonstrated 2 or more Waddell’s signs of inorganic behavior.
  • Patient is in current litigation for back pain/injury, or is currently receiving worker’s compensation.
  • Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
    • Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to enrollment/baseline visit per site standard test.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Susan Moeschler, M.D.

Contact us for the latest status

Contact information:

Michelle Bublitz CCRP

(507) 284-8172

McKenna.Michelle@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available