Spinal Stimulation to Treat Low Back Pain
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 13-003985
NCT ID: NCT02128672
Sponsor Protocol Number: 13-003985
About this study
Spinal cord stimulation (SCS) has been used for almost 30 years to treat many intractable back pain conditions. It has demonstrated efficacy in the co-called Failed Back Surgery Syndrome (FBSS) and a recent randomized controlled trial demonstrated significant superiority of SCS over conventional medical therapy to treat patients with FBSS. Another trial has demonstrated superiority of SCS over repeat surgery in the same patient population. However, the ability to reliably capture the low back with paresthesia coverage has remained challenging and elusive despite numerous strategies designed to overcome this limitation. Strategies that have been introduced but so far with limited success include transverse multiple lead stimulation, high frequency stimulation, peripheral field stimulation, and dorsal root ganglion (DRG) stimulation. To date, none of these strategies have been able to reliably overcome the long-term problems of paresthesia capture and pain relief of the low back.
This proposal describes a new spinal stimulation technique designed to improve the likelihood of low back stimulation by targeting the nerve supply to the two most commonly affected pain producing structures in the back, the facet joints and the intervertebral disks. The technique has proven to be feasible in a cadaver model with ease of lead placement at the desired targets
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. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
- Patients with one sided low back pain
- Failed standard conservative care including medications, physical therapy, and/or injections
- Pain greater than 6 months
- Previous spine surgery
- Pain radiating beyond/below the knee
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Tim Lamer, M.D.
Contact us for the latest status
Tim Lamer M.D.