TARGET Post-Approval Study

Completed

Conditions: Complex Regional Pain Syndrome (CRPS)

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

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

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): 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
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Arizona Pain Specialists
🇺🇸Scottsdale, Arizona, United States