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Spinal Stimulation to Treat Low Back Pain

Primary Purpose

Low Back Pain, Lumbar Back Pain, Lumbago

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Spinal Cord Stimulator Lead Placement
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Conventional SCS lead

    SCS Experimental Lead Placement

    Arm Description

    Conventional Thoracic-lumbar SCS lead placement

    Experimental SCS lead placement in a novel position

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    Numeric Pain Rating Scale (NRS)
    NRS is a validated back pain outcome scale
    Patient preferred stimulation-Likert Scale

    Full Information

    First Posted
    February 18, 2014
    Last Updated
    March 14, 2016
    Sponsor
    Mayo Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02128672
    Brief Title
    Spinal Stimulation to Treat Low Back Pain
    Official Title
    Extraforaminal Spinal Stimulation Compared to Conventional Spinal Cord Stimulation to Treat Axial Low Back Pain-A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    stopped because of competing studies
    Study Start Date
    July 2015 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mayo Clinic

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Back Pain, Lumbar Back Pain, Lumbago

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Conventional SCS lead
    Arm Type
    Active Comparator
    Arm Description
    Conventional Thoracic-lumbar SCS lead placement
    Arm Title
    SCS Experimental Lead Placement
    Arm Type
    Experimental
    Arm Description
    Experimental SCS lead placement in a novel position
    Intervention Type
    Procedure
    Intervention Name(s)
    Spinal Cord Stimulator Lead Placement
    Primary Outcome Measure Information:
    Title
    Did the participant have paresthesia coverage from the stimulation?
    Description
    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).
    Time Frame
    Baseline to 4 days
    Secondary Outcome Measure Information:
    Title
    Numeric Pain Rating Scale (NRS)
    Description
    NRS is a validated back pain outcome scale
    Time Frame
    Baseline to 4 days
    Title
    Patient preferred stimulation-Likert Scale
    Time Frame
    baseline to 4 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tim Lamer, MD
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Spinal Stimulation to Treat Low Back Pain

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