

TARGET: A Post-Approval Study to Evaluate Targeted SCS (DRG) Stimulation for the management of Moderate to Severe Chronic, Intractable, Pain of the Lower Limbs due to CRPS types I and II
Study Coordinator
Susan A. Hahn
484-526-7825
susan.hahn2@sluhn.org
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Synopsis: You are being asked to take part in this research study evaluating the Axium™ Neurostimulator System because your doctor has determined that this device could be beneficial to you in treating your chronic pain of the lower limbs due to Complex Regional Pain Syndrome (CRPS) type I or II. CRPS is a chronic pain condition affecting the arms, legs, hands or feet which usually results from trauma or injury to that body part. Symptoms of CRPS include pain, changes in skin color or temperature in the affected area and swelling
You have previously consented to bring treated with the Axium™ Neurostimulator System. This study will evaluate your response to this treatment method.
The study will collect data about your progress and wellbeing after receiving the device. The purpose of this research study is to evaluate continued safety of the FDA approved Axium Neurostimulator System for the treatment and management of pain of the lower limbs due to complex regional pain syndrome (CRPS) types I and II using spinal cord stimulation conducted by the Axium™ Neurostimulator System. This device is FDA approved and there are no aspects of this clinical study that are considered experimental.
This study will follow the medical care of patients who have lower limb pain due to CRPS. Specifically, you will be evaluated for any possible adverse events (complications or side effects) over the duration of the study.
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