Spinal Stimulation to Treat Low Back Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2015-12-31

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

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Detailed Description

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Conditions

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Low Back Pain Lumbar Back Pain Lumbago

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Conventional SCS lead

Conventional Thoracic-lumbar SCS lead placement

Group Type ACTIVE_COMPARATOR

Spinal Cord Stimulator Lead Placement

Intervention Type PROCEDURE

SCS Experimental Lead Placement

Experimental SCS lead placement in a novel position

Group Type EXPERIMENTAL

Spinal Cord Stimulator Lead Placement

Intervention Type PROCEDURE

Interventions

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Spinal Cord Stimulator Lead Placement

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No