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stopped because of competing studies
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional SCS lead | Active Comparator | Conventional Thoracic-lumbar SCS lead placement |
|
| SCS Experimental Lead Placement | Experimental | Experimental SCS lead placement in a novel position |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Cord Stimulator Lead Placement | Procedure |
|
| 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 |
| 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 |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Tim Lamer, MD | Mayo Clinic | Principal Investigator |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |