A Safety and Effectiveness Trial of Spinal Cord Stimulation of the Dorsal Root Ganglion for Chronic Lower Limb Pain
NCT ID: NCT01923285
Last Updated: 2020-11-24
Study Results
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View full resultsBasic Information
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COMPLETED
NA
152 participants
INTERVENTIONAL
2013-08-31
2016-09-30
Brief Summary
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Detailed Description
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Enrolled subjects were diagnoses with CRPS or peripheral causalgia; experienced pain for at least six months; and failed to achieve adequate pain relief from at least two prior pharmacologic treatments.
All subjects had a temporary trial neurostimulator (TNS). If the subject was a treatment success at the end of TNS they were scheduled for the fully implantable neurostimulator (INS) implant procedure. If not, subjects were exited from the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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AXIUM Neurostimulator System
The AXIUM Neurostimulator System is an investigational spinal cord stimulation device that is designed to stimulate the dorsal root ganglion (DRG) of the spine located on the back surface of the spinal cord where nerves exit the backbone. The device has 2 parts that are placed surgically (implanted) : 1) a pulse generator which is placed under the skin in the buttocks or abdomen, and 2) up to four wires (leads) that have one end attached to the pulse generator, and the other end secured to the tissue near the target treatment area.
AXIUM Neurostimulator System
Control Spinal Cord Stimulation Device
The Control Spinal Cord Stimulation Device is a commercially available spinal cord stimulator indicated for the treatment of chronic lower limb pain.
Control Spinal Cord Stimulation Device
Interventions
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AXIUM Neurostimulator System
Control Spinal Cord Stimulation Device
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject is able and willing to comply with the follow-up schedule and protocol
3. Subject has chronic, intractable pain of the lower limb(s) for at least 6 months
4. Subjects are diagnosed with complex regional pain syndrome (CRPS) and/or peripheral causalgia
5. Subjects have a minimum Visual Analog Scale (VAS) greater than or equal to 60 mm in the area of greatest pain in the lower limbs.
6. Subject has failed to achieve adequate pain relief from at least 2 prior pharmacologic treatments from at least 2 different drugs classes
7. Subject has had stable neurologic function in the past 30 days
8. In the opinion of the Investigator, the subject is psychologically appropriate for the implantation of an active implantable medical device
9. Subject is able to provide written informed consent
Exclusion Criteria
2. Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control
3. Subject has exhibited escalating or changing pain condition within the past 30 days as evidenced by Investigator examination
4. Subject is currently involved in medically related litigation, including workers compensation
5. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
6. Subject's pain medication(s) dosage(s) are not stable for at least 30 days
7. Subject has had radiofrequency treatment of an intended target Dorsal Root Ganglion within the past 3 months
8. Subject has previously failed spinal cord stimulation therapy
9. Subject currently has an active implantable device including implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump or subject requires magnetic resonance imaging (MRIs) or diathermy
10. Subject has pain only within a cervical distribution
11. Subject has cognitive, physical or sensory impairment that, in the opinion of the Investigator, may limit their ability to operate the device
12. Subject currently has an indwelling device that may pose an increased risk of infection
13. Subject currently has an active systemic infection.
14. Subject has, in the opinion of the investigator, a medical comorbidity that contraindicates placement of an active medical device
15. Subject has participated in another clinical investigation within 30 days
16. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the Investigator, precludes participation
17. Subject has been diagnosed with cancer in the past 2 years
18. Imaging (MRI, CT, x-ray) findings within the last 12 months that, in the Investigator's opinion, contraindicates lead placement
19. Subject is a prisoner
22 Years
75 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Robyn Capobianco, PhD
Role: STUDY_DIRECTOR
Abbott
Locations
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HOPE Research - TPC
Phoenix, Arizona, United States
Pain Clinic of Monterey Bay
Aptos, California, United States
Coastal Pain Research
Carlsbad, California, United States
Neurovations, Inc.
Napa, California, United States
Newport Beach Headache and Pain
Newport Beach, California, United States
Eisenhower Medical Center
Rancho Mirage, California, United States
Orthopaedic Pain Specialists
Santa Monica, California, United States
IPM Medical Group, Inc.
Walnut Creek, California, United States
Florida Pain Institute
Merritt Island, Florida, United States
Holy Cross Hospital Orthopedic Institute
Oakland Park, Florida, United States
Drug Studies of America
Marietta, Georgia, United States
Comprehensive Pain and Rehabilitation
Pascagoula, Mississippi, United States
Pain Management Associates
Independence, Missouri, United States
HOPE Research - LVSP
Las Vegas, Nevada, United States
Premier Pain Center
Shrewsbury, New Jersey, United States
The Center for Clinical Research
Winston-Salem, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Clinical Trials of South Carolina
Charleston, South Carolina, United States
Southeastern Spine Institute
Mt. Pleasant, South Carolina, United States
Houston Pain Centers
Houston, Texas, United States
Center for Pain Relief
Charleston, West Virginia, United States
Center for Pain Relief Tri-State
Huntington, West Virginia, United States
Countries
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References
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Levy RM, Mekhail N, Kramer J, Poree L, Amirdelfan K, Grigsby E, Staats P, Burton AW, Burgher AH, Scowcroft J, Golovac S, Kapural L, Paicius R, Pope J, Samuel S, McRoberts WP, Schaufele M, Kent AR, Raza A, Deer TR. Therapy Habituation at 12 Months: Spinal Cord Stimulation Versus Dorsal Root Ganglion Stimulation for Complex Regional Pain Syndrome Type I and II. J Pain. 2020 Mar-Apr;21(3-4):399-408. doi: 10.1016/j.jpain.2019.08.005. Epub 2019 Sep 5.
Other Identifiers
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03-SMI-2012
Identifier Type: -
Identifier Source: org_study_id