Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
426 participants
OBSERVATIONAL
2016-08-23
2021-09-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Dorsal Root Ganglion (DRG) Stimulation
Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System)
Electrical stimulation of the DRG using the Axium™ Neurostimulator System
Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System)
Electrical Stimulation of the DRG using the Proclaim™ Neurostimulator System.
Interventions
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Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System)
Electrical stimulation of the DRG using the Axium™ Neurostimulator System
Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System)
Electrical Stimulation of the DRG using the Proclaim™ Neurostimulator System.
Eligibility Criteria
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Inclusion Criteria
* Subject has moderate to severe chronic intractable pain of the lower limbs resulting from Complex Regional Pain Syndrome (CRPS) types I or II.
* Subject has a baseline Visual Analogue Scale (VAS) of ≥ 60 mm for overall pain at the time of the baseline assessment.
* Subject is willing and able to comply with the study requirements.
* Subject is able to provide written informed consent.
Exclusion Criteria
* Subject is currently involved in medically related litigation, including workers compensation.
* Subject has a life expectancy of less than one year.
* Subject is pregnant or of child bearing potential and not using adequate contraception as determined by the investigator.
* Subject has, or plans to have, a spinal cord stimulation system or infusion pump system implanted.
* Subject has, or plans to have, a peripheral nerve stimulation system (PNS) or peripheral nerve field stimulation system (PNfS) implanted.
* Subject is considered to be a poor surgical or study candidate, which may include, but is not limited to the following: any medical, social, or psychological problem that could complicate the implant procedure and/or recovery from the implant procedure or could complicate the required procedures and evaluations of the study in the judgment of the investigator.
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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Ann Jannu, PhD, CCRP
Role: STUDY_DIRECTOR
Abbott Neuromodulation
Locations
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Arizona Pain Specialists
Scottsdale, Arizona, United States
Spanish Hills Interventional Pain Specialists
Camarillo, California, United States
California Orthopedics & Spine
Larkspur, California, United States
Loma Linda University Hospital
Loma Linda, California, United States
VA Loma Linda Healthcare System
Loma Linda, California, United States
University of California - San Francisco
San Francisco, California, United States
Orthopedic Pain Specialists
Santa Monica, California, United States
Summit Pain Alliance Inc.
Santa Rosa, California, United States
Pacific Research Institute
Santa Rosa, California, United States
Front Range Pain Medicine
Fort Collins, Colorado, United States
Coastal Orthopedics & Sports Medicine Southwest FL
Bradenton, Florida, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
University of Florida - Department of Anesthesia
Gainesville, Florida, United States
Florida Pain Institute
Merritt Island, Florida, United States
Better Health Clinical Research
Newnan, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Goodman Campbell Brain & Spine
Indianapolis, Indiana, United States
Kansas University Medical Center
Kansas City, Kansas, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Nura
Edina, Minnesota, United States
Twin Cities Pain Clinic
Edina, Minnesota, United States
Advanced Pain Care
Henderson, Nevada, United States
Nevada Advanced Pain Specialists
Reno, Nevada, United States
Ainsworth Institute of Pain Management
New York, New York, United States
The Spine & Pain Institute of New York
Staten Island, New York, United States
Premier Pain Solutions
Asheville, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Adena Bone and Joint Center
Chillicothe, Ohio, United States
The Cleveland Clinic
Cleveland, Ohio, United States
Pacific Sports and Spine
Eugene, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
Spinal Diagnostics
Tualatin, Oregon, United States
Center for Intervetional Pain and Spine
Exton, Pennsylvania, United States
Main Line Spine
King of Prussia, Pennsylvania, United States
Thomas Jefferson Department of Neurosurgery
Philadelphia, Pennsylvania, United States
Pain Diagnostics and Interventional Care
Sewickley, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Carolinas Center for Advanced Management of Pain
Greenville, South Carolina, United States
Vertex Spine and Pain
Franklin, Tennessee, United States
Central Texas Pain Institute
Killeen, Texas, United States
Advanced Pain Solutions
Mesquite, Texas, United States
Shannon Clinic
San Angelo, Texas, United States
The Spine and Nerve Center of St. Francis
Charleston, West Virginia, United States
Advanced Pain Management
Greenfield, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SJM-CIP-10113
Identifier Type: -
Identifier Source: org_study_id
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