TARGET Post-Approval Study (TARGET PAS)

TARGET: A Post-Approval Study to Evaluate Targeted SCS Spinal Cord Stimulation (SCS) Dorsal Root Ganglion (DRG) Stimulation for the Management of Moderate to Severe Chronic, Intractable, Pain of the Lower Limbs Due to CRPS Types I and II

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.

Study Overview

• Status: Completed
• Conditions: Complex Regional Pain Syndrome (CRPS)
• Intervention / Treatment: Device: Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System); Device: Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System)

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.

• Study Type: Observational
• Enrollment (Actual): 426

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Arizona Pain Specialists
  • California
    • Camarillo, California, United States, 93010
      • Spanish Hills Interventional Pain Specialists
    • Larkspur, California, United States, 94939
      • California Orthopedics & Spine
    • Loma Linda, California, United States, 92357
      • VA Loma Linda Healthcare System
    • Loma Linda, California, United States, 92354
      • Loma Linda University Hospital
    • San Francisco, California, United States, 94143
      • University of California - San Francisco
    • Santa Monica, California, United States, 90403
      • Orthopedic Pain Specialists
    • Santa Rosa, California, United States, 95401
      • Summit Pain Alliance Inc.
    • Santa Rosa, California, United States, 95403
      • Pacific Research Institute
  • Colorado
    • Fort Collins, Colorado, United States, 80525
      • Front Range Pain Medicine
  • Florida
    • Bradenton, Florida, United States, 34209
      • Coastal Orthopedics & Sports Medicine Southwest FL
    • Fort Lauderdale, Florida, United States, 33308
      • Holy Cross Hospital
    • Gainesville, Florida, United States, 32610
      • University of Florida - Department of Anesthesia
    • Merritt Island, Florida, United States, 32953
      • Florida Pain Institute
  • Georgia
    • Newnan, Georgia, United States, 30265
      • Better Health Clinical Research
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Goodman Campbell Brain & Spine
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Kansas University Medical Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Nura
    • Edina, Minnesota, United States, 55439
      • Twin Cities Pain Clinic
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Advanced Pain Care
    • Reno, Nevada, United States, 89511
      • Nevada Advanced Pain Specialists
  • New York
    • New York, New York, United States, 10022
      • Ainsworth Institute of Pain Management
    • Staten Island, New York, United States, 10305
      • The Spine & Pain Institute of New York
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Premier Pain Solutions
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Chillicothe, Ohio, United States, 45601
      • Adena Bone and Joint Center
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic
  • Oregon
    • Eugene, Oregon, United States, 97404
      • Pacific Sports and Spine
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
    • Tualatin, Oregon, United States, 97062
      • Spinal Diagnostics
  • Pennsylvania
    • Exton, Pennsylvania, United States, 19341
      • Center for Intervetional Pain and Spine
    • King Of Prussia, Pennsylvania, United States, 19406
      • Main Line Spine
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson Department of Neurosurgery
    • Sewickley, Pennsylvania, United States, 15143
      • Pain Diagnostics and Interventional Care
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Carolinas Center for Advanced Management of Pain
  • Tennessee
    • Franklin, Tennessee, United States, 37067
      • Vertex Spine and Pain
  • Texas
    • Killeen, Texas, United States, 76542
      • Central Texas Pain Institute
    • Mesquite, Texas, United States, 75150
      • Advanced Pain Solutions
    • San Angelo, Texas, United States, 76903
      • Shannon Clinic
  • West Virginia
    • Charleston, West Virginia, United States, 25301
      • The Spine and Nerve Center of St. Francis
  • Wisconsin
    • Greenfield, Wisconsin, United States, 53221
      • Advanced Pain Management

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult subjects aged 22 to 75 with moderate to severe chronic, intractable, pain of the lower limbs due to CRPS types I and II with a baseline VAS score of 6 or greater.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dorsal Root Ganglion (DRG) Stimulation	Device: Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System); Electrical stimulation of the DRG using the Axium™ Neurostimulator System; Device: Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System); Electrical Stimulation of the DRG using the Proclaim™ Neurostimulator System.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Serious Adverse Events (SAEs)	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.	throughout 12 month study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline to 12 Months Post-permanent Implant for Overall Pain Intensity Measured Using the Visual Analog Scale (VAS)	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.	12 months
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	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.	12 months
Change From Baseline to 12 Months Post-permanent Implant for Quality of Life Measured Using the PROMIS Global Health Scale	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.	12 months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Ann Jannu, PhD, CCRP, Abbott Neuromodulation

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2016
• Primary Completion (Actual): September 23, 2021
• Study Completion (Actual): September 23, 2021

Study Registration Dates

• First Submitted: June 7, 2016
• First Submitted That Met QC Criteria: June 14, 2016
• First Posted (Estimated): June 15, 2016

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Chronic pain; Complex Regional Pain Syndrome (CRPS); SJM-CIP-10113
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Autonomic Nervous System Diseases; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy
• Other Study ID Numbers: SJM-CIP-10113