Spinal Stimulation to Treat Low Back Pain
Status: | Not yet recruiting |
---|---|
Conditions: | Back Pain, Back Pain |
Therapuetic Areas: | Musculoskeletal |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/12/2016 |
Start Date: | July 2015 |
End Date: | December 2016 |
Extraforaminal Spinal Stimulation Compared to Conventional Spinal Cord Stimulation to Treat Axial Low Back Pain-A Pilot 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
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
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
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