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Withdrawn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
About this trial
This is an interventional treatment trial for Low Back Pain
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
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
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Withdrawn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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