Low Back Pain, Lumbago, Lumbar Back Pain
Conditions
Brief summary
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
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
Inclusion: * Patients with one sided low back pain * Failed standard conservative care including medications, physical therapy, and/or injections * Pain greater than 6 months Exclusion: * Pregnancy * Previous spine surgery * Pain radiating beyond/below the knee
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Did the participant have paresthesia coverage from the stimulation? | Baseline to 4 days | This is a simple yes or no outcome. Either the patient is able to feel the stimulation paresthesia in the area of his or her back where he or she has pain (outcome is yes) or they do not feel it (outcome is no). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Rating Scale (NRS) | Baseline to 4 days | NRS is a validated back pain outcome scale |
| Patient preferred stimulation-Likert Scale | baseline to 4 days | — |