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

Completed · Not applicable

Conditions studied: Chronic Lower Limb Pain

In brief

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).

Key facts

Study ID: NCT01923285
Run by: Abbott Medical Devices
People needed: 152
Starts: 2013-08-01
Expected to finish: 2016-09-01
Last updated by the study team: 2020-11-24

Who can join

Age: 22 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject is male or female between the ages of 22 and 75 years
Subject is able and willing to comply with the follow-up schedule and protocol
Subject has chronic, intractable pain of the lower limb(s) for at least 6 months
Subjects are diagnosed with complex regional pain syndrome (CRPS) and/or peripheral causalgia
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.
Subject has failed to achieve adequate pain relief from at least 2 prior pharmacologic treatments from at least 2 different drugs classes
Subject has had stable neurologic function in the past 30 days
In the opinion of the Investigator, the subject is psychologically appropriate for the implantation of an active implantable medical device
Subject is able to provide written informed consent

You may not qualify if…

Back pain is the greatest region of pain as measured on the baseline VAS.
Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control
Subject has exhibited escalating or changing pain condition within the past 30 days as evidenced by Investigator examination
Subject is currently involved in medically related litigation, including workers compensation
Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
Subject's pain medication(s) dosage(s) are not stable for at least 30 days
Subject has had radiofrequency treatment of an intended target Dorsal Root Ganglion within the past 3 months
Subject has previously failed spinal cord stimulation therapy
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
Subject has pain only within a cervical distribution
Subject has cognitive, physical or sensory impairment that, in the opinion of the Investigator, may limit their ability to operate the device
Subject currently has an indwelling device that may pose an increased risk of infection
Subject currently has an active systemic infection.
Subject has, in the opinion of the investigator, a medical comorbidity that contraindicates placement of an active medical device
Subject has participated in another clinical investigation within 30 days
Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the Investigator, precludes participation
Subject has been diagnosed with cancer in the past 2 years
Imaging (MRI, CT, x-ray) findings within the last 12 months that, in the Investigator's opinion, contraindicates lead placement
Subject is a prisoner

Where it is running

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

Full record on ClinicalTrials.gov

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