Spinal Stimulation to Treat Low Back Pain

Not Applicable

Withdrawn

• Conditions: Lumbago; Low Back Pain; Lumbar Back Pain
• Interventions: Procedure: Spinal Cord Stimulator Lead Placement

• Registration Number: NCT02128672
• Lead Sponsor: Mayo Clinic

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-18
• Study First Submitted QC: 2014-04-30
• Study First Posted: 2014-05-01
• Study Start: 2015-07
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-14
• Last Update Posted: 2016-03-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Conventional SCS lead	Spinal Cord Stimulator Lead Placement	Conventional Thoracic-lumbar SCS lead placement
SCS Experimental Lead Placement	Spinal Cord Stimulator Lead Placement	Experimental SCS lead placement in a novel position

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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