TARGET Post-Approval Study
- Conditions
- Complex Regional Pain Syndrome (CRPS)
- Interventions
- Device: Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System)Device: Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System)
- Registration Number
- NCT02800863
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
The purpose of this prospective, multicenter, single arm post-approval study is to demonstrate continued safety of the Axium and Proclaim Neurostimulator System for dorsal root ganglion (DRG) stimulation. The primary endpoint is the 12-month serious adverse event rate for permanent implants.
- Detailed Description
A maximum of 426 adult subjects with moderate to severe chronic, intractable, pain of the lower limbs due to CRPS types I and II will undergo a trial of the Axium or Proclaim Neurostimulator System across up to 45 study sites in the United States. Only subjects who report a 50% or greater reduction in overall pain intensity through direct patient-reported percentage of pain relief will receive the permanent implant. Subjects will then return to the office for follow-up at 1, 3, 6 and 12 months post-permanent implant.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 426
- Subject is male or female between ≥ 22 and ≤ 75 years of age.
- 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.
- Subject has an active implantable medical device including but not limited to cardiac pacemakers and cardiac defibrillators.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Dorsal Root Ganglion (DRG) Stimulation Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System) - Dorsal Root Ganglion (DRG) Stimulation Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System) -
- Primary Outcome Measures
Name Time Method Rate of Serious Adverse Events (SAEs) throughout 12 month study The serious adverse event rate for subjects receiving the permanent DRG implantable pulse generator (IPG) was analyzed using Kaplan-Meier method on subjects who received the permanent Axium or Proclaim DRG IPG (N = 296). While 426 patients were enrolled, only 296 received the permanent implant. The primary population is 296.
- Secondary Outcome Measures
Name Time Method Percent Change From Baseline to 12 Months Post-permanent Implant for Overall Pain Intensity Measured Using the Visual Analog Scale (VAS) 12 months The VAS is a common, self-administered measure in which subjects rate their pain intensity by marking a vertical line through a 100 mm horizontal line anchored by word descriptors on each end (no pain to worst imaginable pain). The distance between the beginning of the horizontal line and the vertical line is measured to produce a score between 0 and 100 mm (or 0 to 10 cm). A higher score indicates higher pain intensity and a 30% reduction in VAS score from baseline to follow-up is considered clinically relevant.
Change From Baseline to 12 Months Post-permanent Implant for Quality of Life Measured Using the PROMIS Global Health Scale 12 months The PROMIS Global Health short form is a validated, 10-item instrument designed to assess multiple health domains. The questionnaire yields a total score and sub-scale scores for Global Physical and Mental Health. Each question has potential five response options ranging in value from one to five to give a total score ranging from 10 to 50. All questions must be answered to arrive at a total score as one or more missing responses will render scores unusable. Scores are converted into t-scores where the average for the general US population is 50 and the SD is 10. Higher scores indicate better global health.
Change From Baseline to 12 Months Post-permanent Implant for Physical Function Measured Using the Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) Physical Function Scale 12 months The PROMIS-29 Profile is an instrument made up of seven individual short forms (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference) that are scored individually. The instrument also includes a single pain intensity item which is reported as its raw score (e.g., 0 to 10). Each item has five response options ranging in value from 1 to 5, except for the Pain Intensity item which has eleven response options ranging in value from 0 to 10. A raw score is created from each short form that makes up the Profile. Raw scores are calculated by summing the values of the response to each question within each domain.
Trial Locations
- Locations (44)
Pacific Sports and Spine
🇺🇸Eugene, Oregon, United States
Arizona Pain Specialists
🇺🇸Scottsdale, Arizona, United States
Spanish Hills Interventional Pain Specialists
🇺🇸Camarillo, California, United States
VA Loma Linda Healthcare System
🇺🇸Loma Linda, California, United States
Loma Linda University Hospital
🇺🇸Loma Linda, California, United States
Front Range Pain Medicine
🇺🇸Fort Collins, Colorado, 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
Holy Cross Hospital
🇺🇸Fort Lauderdale, Florida, United States
Florida Pain Institute
🇺🇸Merritt Island, Florida, United States
Better Health Clinical Research
🇺🇸Newnan, Georgia, United States
Kansas University Medical Center
🇺🇸Kansas City, Kansas, United States
Nura
🇺🇸Edina, Minnesota, United States
Advanced Pain Care
🇺🇸Henderson, Nevada, United States
Ainsworth Institute of Pain Management
🇺🇸New York, New York, United States
Twin Cities Pain Clinic
🇺🇸Edina, Minnesota, United States
Nevada Advanced Pain Specialists
🇺🇸Reno, Nevada, United States
Premier Pain Solutions
🇺🇸Asheville, North Carolina, United States
Adena Bone and Joint Center
🇺🇸Chillicothe, Ohio, United States
Main Line Spine
🇺🇸King Of Prussia, Pennsylvania, United States
Spinal Diagnostics
🇺🇸Tualatin, Oregon, United States
Center for Intervetional Pain and Spine
🇺🇸Exton, Pennsylvania, United States
Pain Diagnostics and Interventional Care
🇺🇸Sewickley, Pennsylvania, United States
Central Texas Pain Institute
🇺🇸Killeen, Texas, United States
Vertex Spine and Pain
🇺🇸Franklin, Tennessee, United States
Carolinas Center for Advanced Management of Pain
🇺🇸Greenville, South Carolina, United States
Shannon Clinic
🇺🇸San Angelo, Texas, United States
The Spine and Nerve Center of St. Francis
🇺🇸Charleston, West Virginia, United States
Advanced Pain Solutions
🇺🇸Mesquite, Texas, United States
Advanced Pain Management
🇺🇸Greenfield, Wisconsin, United States
California Orthopedics & Spine
🇺🇸Larkspur, California, United States
University of California - San Francisco
🇺🇸San Francisco, California, United States
Coastal Orthopedics & Sports Medicine Southwest FL
🇺🇸Bradenton, Florida, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Goodman Campbell Brain & Spine
🇺🇸Indianapolis, Indiana, United States
The Spine & Pain Institute of New York
🇺🇸Staten Island, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
The Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Thomas Jefferson Department of Neurosurgery
🇺🇸Philadelphia, Pennsylvania, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
University of Florida - Department of Anesthesia
🇺🇸Gainesville, Florida, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States