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A Safety and Effectiveness Trial of Spinal Cord Stimulation of the Dorsal Root Ganglion for Chronic Lower Limb Pain (ACCURATE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01923285
First Posted: August 15, 2013
Last Update Posted: October 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Jude Medical
  Purpose
The purpose of this study is to evaluate the safety and effectiveness of the AXIUM Neurostimulator System for the treatment of chronic lower limb pain in persons diagnosed with Complex Regional Pain Syndrome (CRPS) or Peripheral Causalgia (PC).

Condition Intervention
Chronic Lower Limb Pain Device: AXIUM Neurostimulator System Device: Control Spinal Cord Stimulation Device

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Multi-Center, Controlled Clinical Trial to Assess the Safety and Efficacy of the Spinal Modulation™ AXIUM™ Neurostimulator System in the Treatment of Chronic Pain (ACCURATE Trial)

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Treatment Success [ Time Frame: 3 months ]
    Treatment Success is defined as a reduction in pain score greater than or equal to 50 percent and the absence of a stimulation related neurological deficit.


Enrollment: 152
Study Start Date: August 2013
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Device: AXIUM Neurostimulator System
Other Name: DRG Stimulation
Active Comparator: 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.
Device: Control Spinal Cord Stimulation Device
Other Name: SCS

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is male or female between the ages of 22 and 75 years
  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:

  1. Back pain is the greatest region of pain as measured on the baseline VAS.
  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
  Contacts and Locations
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): NCT01923285


Locations
United States, Arizona
HOPE Research - TPC
Phoenix, Arizona, United States, 85018
United States, California
Pain Clinic of Monterey Bay
Aptos, California, United States, 94025
Coastal Pain Research
Carlsbad, California, United States, 94025
Neurovations, Inc.
Napa, California, United States, 94558
Newport Beach Headache and Pain
Newport Beach, California, United States, 94025
Eisenhower Medical Center
Rancho Mirage, California, United States, 94025
Orthopaedic Pain Specialists
Santa Monica, California, United States, 94025
IPM Medical Group, Inc.
Walnut Creek, California, United States, 94598
United States, Florida
Florida Pain Institute
Merritt Island, Florida, United States, 32953
Holy Cross Hospital Orthopedic Institute
Oakland Park, Florida, United States, 33334
United States, Georgia
Drug Studies of America
Marietta, Georgia, United States, 30060
United States, Mississippi
Comprehensive Pain and Rehabilitation
Pascagula, Mississippi, United States, 39581
United States, Missouri
Pain Management Associates
Independence, Missouri, United States, 64055
United States, Nevada
HOPE Research - LVSP
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Premier Pain Center
Shrewsbury, New Jersey, United States, 07702
United States, North Carolina
The Center for Clinical Research
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, South Carolina
Clinical Trials of South Carolina
Charleston, South Carolina, United States, 29406
Southeastern Spine Institute
Mt. Pleasant, South Carolina, United States, 29464
United States, Texas
Houston Pain Centers
Houston, Texas, United States, 77030
United States, West Virginia
Center for Pain Relief
Charleston, West Virginia, United States, 25301
Center for Pain Relief Tri-State
Huntington, West Virginia, United States, 25702
Sponsors and Collaborators
St. Jude Medical
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01923285     History of Changes
Other Study ID Numbers: 03-SMI-2012
First Submitted: August 13, 2013
First Posted: August 15, 2013
Last Update Posted: October 18, 2016
Last Verified: October 2016