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Spinal Stimulation to Treat Low Back Pain

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ClinicalTrials.gov Identifier: NCT02128672
Recruitment Status : Withdrawn (stopped because of competing studies)
First Posted : May 1, 2014
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
Tim J. Lamer, M.D., 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


Condition or disease Intervention/treatment Phase
Low Back Pain Lumbar Back Pain Lumbago Procedure: Spinal Cord Stimulator Lead Placement Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Extraforaminal Spinal Stimulation Compared to Conventional Spinal Cord Stimulation to Treat Axial Low Back Pain-A Pilot Study
Study Start Date : July 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Conventional SCS lead
Conventional Thoracic-lumbar SCS lead placement
Procedure: Spinal Cord Stimulator Lead Placement
Experimental: SCS Experimental Lead Placement
Experimental SCS lead placement in a novel position
Procedure: Spinal Cord Stimulator Lead Placement



Primary Outcome Measures :
  1. Did the participant have paresthesia coverage from the stimulation? [ Time Frame: 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 :
  1. Numeric Pain Rating Scale (NRS) [ Time Frame: Baseline to 4 days ]
    NRS is a validated back pain outcome scale

  2. Patient preferred stimulation-Likert Scale [ Time Frame: baseline to 4 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128672


Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Tim Lamer, MD Mayo Clinic

Responsible Party: Tim J. Lamer, M.D., Associate Professor of Anesthesiology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02128672     History of Changes
Other Study ID Numbers: 13-003985
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms