TARGET POST-APPROVAL STUDY
A Post-Approval Study to Evaluate DRG Stimulation for the Treatment of CRPS of the Lower Extremity
The Ainsworth Institute of Pain Management has been selected join a phase IV clinical trial studying the safety and continued efficacy of the Dorsal Root Ganglion (DRG) Stimulation for the treatment of Complex Regional Pain Syndrome Type (CRPS) – TARGET Study.
CRPS (aka Reflex Sympathetic Dystrophy of RSD) chronic and progressive condition causing excruciating pain. CRPS, according to definition, affects the upper and lower extremities and is more likely in women than in men. The general definition is:
CRPS describes an array of painful conditions that are characterized by a continuing (spontaneous and/or evoked) regional pain that is seemingly disproportionate in time or degree to the usual course of any known trauma or other lesion. The pain is regional (not in a specific nerve territory or dermatome) and usually has a distal predominance of abnormal sensory, motor, sudomotor, vasomotor, and/or trophic findings. The syndrome shows variable progression over time.
Traditionally, the treatments for CRPS include:
The purpose of this prospective, multicenter, single arm post-approval study is to demonstrate continued safety of the Axium Neurostimulator System for dorsal root ganglion (DRG) stimulation. The primary endpoint is the 12-month serious adverse event rate for permanent implants
 Benzon, Honorio. Essentials of Pain Medicine. Philadelphia: Saunders Elsevier, 2011. Print
DRG stimulation is one of THE most impressive advancements ever seen in the field of pain management. According to the United States FDA clinical trial, patients with CRPS who were treated with the DRG stimulator reported, on average, 81.4% to 86% reduction in pain. In addition, sensitivity, swelling and skin color – all have been have been shown to improve with this amazing therapy.
An Intrathecal Pump is a targeted drug delivery system that delivers amazingly small amounts of medication directly to the central nervous system. Several medications can be used simultaneously within these pumps to create profound pain relief while limiting the side effects that are commonly reported with oral medications. The primary benefit of a pump around-the-clock pain relief, even while you’re sleeping.
Can I Participate in this Study?
Details of the Study
A maximum of 376 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 Neurostimulator System across 40 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. To qualify for this study one will need to have valid insurance as this treatment will be processed through your insurance. As this is a post-market study, the treatment will be paid for by your insurance – all visits and/or tests required by the study sponsor will be paid for by the sponsor (Abbott).
Study Enrollment Form
Official Protocol Name: 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
Get Answers to Your Questions at the Ainsworth Institute
The key to finding the proper treatment for any type of pain is getting a proper diagnosis. Not all types of pain respond to the same treatments and the window for improvement can be limited. The experts at Ainsworth Institute offer the most advanced pain management treatments available today, including advanced clinical trials that aren’t yet available to the general public. Call us today for an appointment so we can get you started on your road to recovery.