Spinal Stimulation to Treat Low Back Pain

NCT02128672 | Withdrawn

• 1 other identifier: 13-003985
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Low Back Pain; Lumbar Back Pain; Lumbago

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Numeric Pain Rating Scale (NRS)

  Baseline to 4 days

• Patient preferred stimulation-Likert Scale

  baseline to 4 days

Study Arms (2)

Conventional SCS lead

ACTIVE COMPARATOR

Conventional Thoracic-lumbar SCS lead placement

Procedure: Spinal Cord Stimulator Lead Placement

SCS Experimental Lead Placement

EXPERIMENTAL

Experimental SCS lead placement in a novel position

Procedure: Spinal Cord Stimulator Lead Placement

Interventions

Spinal Cord Stimulator Lead Placement PROCEDURE

Conventional SCS lead; SCS Experimental Lead Placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with one sided low back pain
• Failed standard conservative care including medications, physical therapy, and/or injections
• Pain greater than 6 months

You may not qualify if:

• Pregnancy
• Previous spine surgery
• Pain radiating beyond/below the knee

Sponsors & Collaborators

• Mayo Clinic: lead

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tim Lamer, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: May 1, 2014
• Study Start: July 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 16, 2016

Record last verified: 2016-03