Spinal Stimulation to Treat Low Back Pain

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Tim J. Lamer, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02128672
First received: February 18, 2014
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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 Intervention
Low Back Pain
Lumbar Back Pain
Lumbago
Procedure: Spinal Cord Stimulator Lead Placement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Did the participant have paresthesia coverage from the stimulation? [ Time Frame: Baseline to 4 days ] [ Designated as safety issue: No ]
    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:
  • Numeric Pain Rating Scale (NRS) [ Time Frame: Baseline to 4 days ] [ Designated as safety issue: No ]
    NRS is a validated back pain outcome scale

  • Patient preferred stimulation-Likert Scale [ Time Frame: baseline to 4 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 5
Study Start Date: May 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02128672

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Tim Lamer, MD Mayo Clinic
  More Information

No publications provided

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
Study First Received: February 18, 2014
Last Updated: April 30, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 23, 2014