Spinal Stimulation to Treat Low Back Pain

Study Overview
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Brief Summary
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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

Official Title
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Extraforaminal Spinal Stimulation Compared to Conventional Spinal Cord Stimulation to Treat Axial Low Back Pain-A Pilot Study

Conditions
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Low Back Pain, Lumbar Back Pain, Lumbago

Intervention / Treatment
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* Procedure: Spinal Cord Stimulator Lead Placement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional SCS lead<br>Conventional Thoracic-lumbar SCS lead placement | Procedure: Spinal Cord Stimulator Lead Placement<br> <br> |
| Experimental: SCS Experimental Lead Placement<br>Experimental SCS lead placement in a novel position | Procedure: Spinal Cord Stimulator Lead Placement<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Did the participant have paresthesia coverage from the stimulation? | 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). | Baseline to 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Pain Rating Scale (NRS) | NRS is a validated back pain outcome scale | Baseline to 4 days | 
| Patient preferred stimulation-Likert Scale |  | baseline to 4 days |