Clinical trial NCT02800863: TARGET Post-Approval Study
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complex Regional Pain Syndrome (CRPS)
Keywords: Complex Regional Pain Syndrome (CRPS)
Chronic pain
SJM-CIP-10113
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2016-06-15
Enrollment: 426
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Serious Adverse Events (SAEs)
timeFrame: throughout 12 month study
Secondary outcomes:
measure: Percent Change From Baseline to 12 Months Post-permanent Implant for Overall Pain Intensity Measured Using the Visual Analog Scale (VAS)
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: Change From Baseline to 12 Months Post-permanent Implant for Quality of Life Measured Using the PROMIS Global Health Scale
timeFrame: 12 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Arizona Pain Specialists
state: Arizona
city: Camarillo
country: United States
facility: Spanish Hills Interventional Pain Specialists
state: California
city: Larkspur
country: United States
facility: California Orthopedics & Spine
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Hospital
state: California
city: Loma Linda
country: United States
facility: VA Loma Linda Healthcare System
state: California
city: San Francisco
country: United States
facility: University of California - San Francisco
state: California
city: Santa Monica
country: United States
facility: Orthopedic Pain Specialists
state: California
city: Santa Rosa
country: United States
facility: Summit Pain Alliance Inc.
state: California
city: Santa Rosa
country: United States
facility: Pacific Research Institute
state: California
city: Fort Collins
country: United States
facility: Front Range Pain Medicine
state: Colorado
city: Bradenton
country: United States
facility: Coastal Orthopedics & Sports Medicine Southwest FL
state: Florida
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Gainesville
country: United States
facility: University of Florida - Department of Anesthesia
state: Florida
city: Merritt Island
country: United States
facility: Florida Pain Institute
state: Florida
city: Newnan
country: United States
facility: Better Health Clinical Research
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Goodman Campbell Brain & Spine
state: Indiana
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Edina
country: United States
facility: Nura
state: Minnesota
city: Edina
country: United States
facility: Twin Cities Pain Clinic
state: Minnesota
city: Henderson
country: United States
facility: Advanced Pain Care
state: Nevada
city: Reno
country: United States
facility: Nevada Advanced Pain Specialists
state: Nevada
city: New York
country: United States
facility: Ainsworth Institute of Pain Management
state: New York
city: Staten Island
country: United States
facility: The Spine & Pain Institute of New York
state: New York
city: Asheville
country: United States
facility: Premier Pain Solutions
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Chillicothe
country: United States
facility: Adena Bone and Joint Center
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
city: Eugene
country: United States
facility: Pacific Sports and Spine
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Tualatin
country: United States
facility: Spinal Diagnostics
state: Oregon
city: Exton
country: United States
facility: Center for Intervetional Pain and Spine
state: Pennsylvania
city: King Of Prussia
country: United States
facility: Main Line Spine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson Department of Neurosurgery
state: Pennsylvania
city: Sewickley
country: United States
facility: Pain Diagnostics and Interventional Care
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Greenville
country: United States
facility: Carolinas Center for Advanced Management of Pain
state: South Carolina
city: Franklin
country: United States
facility: Vertex Spine and Pain
state: Tennessee
city: Killeen
country: United States
facility: Central Texas Pain Institute
state: Texas
city: Mesquite
country: United States
facility: Advanced Pain Solutions
state: Texas
city: San Angelo
country: United States
facility: Shannon Clinic
state: Texas
city: Charleston
country: United States
facility: The Spine and Nerve Center of St. Francis
state: West Virginia
city: Greenfield
country: United States
facility: Advanced Pain Management
state: Wisconsin
Study officials:
affiliation: Abbott Neuromodulation
name: Ann Jannu, PhD, CCRP
role: STUDY_DIRECTOR
References: