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SLUHN 2017-20

MulTi-center pRospectIve stUdy deterMining the sustainability of Pain relief and psychosocial and functional responses wHen utilizing a multiple waveform enabled neurostimulator

  • Physician & Study Coordinator
  • Synopsis
  • Inclusion Criteria
  • Exclusion Criteria
  • Study Coordinator

    Susan A. Hahn

  • Synopsis: You are being asked to take part in this research study evaluating a spinal cord stimulation device because your doctor has determined that spinal cord stimulation could be beneficial to you in treating your chronic intractable pain of the trunk and/or limbs. The device used in this study is called a multiple waveform enabled device, which means it can provide both stable (tonic) and changing (Burst) electrical stimulation to the spinal cord which may improve pain control. With the data we collect from your participation, we will be able to further investigate the tonic and Burst waveforms and their impact on you, your pain and your daily life. In general, spinal cord stimulation works by applying electrical current to the source of chronic pain that blocks the brain’s ability to sense the previously detected pain.

    The sponsor is interested in collecting data to evaluate stimulators that can stimulate with a tonic or Burst waveform (multiple waveform enabled stimulators). The goal is to collect data on your pain relief, your pain feelings, your daily activities, the settings that your physician has programmed and how you use the device. With these data, the sponsor will be able to evaluate the quality and the performance of the device and it will give a better understanding of chronic pain.

    Some of the actions/data collection that will be done in this study are part of your normal care and would be done even if you were not in the study. The study team will let you know which parts of the study are not considered to be part of your normal care.

    • Subject has chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome and intractable low back and leg pain.
    • Subject has a score of 6 or higher on the NRS for average pain specific to the area(s) of chronic pain being treated over the past 24 hours at the baseline visit.
    • Subject is considered by the Investigator as a candidate for implantation of a spinal cord stimulator system according to the system Instructions For Use.
    • Subject is 18 years of age or older at the time of enrollment.
    • Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all study visits.
    • Subject has signed and received a copy of the Ethics Committee/Institutional Review Board (EC/IRB) approved informed consent.
    • Subject currently has a spinal cord stimulation system implanted.
    • Subject has previously failed SCS therapy (either trial system evaluation or permanent implant).
    • Subject has a primary diagnosis of Peripheral Vascular Disease (PVD), Angina Pectoris, or Chronic Migraine.
    • Subject has or plans to have a Peripheral Nerve Stimulation system (PNS), Peripheral Nerve field Stimulation system (PNfS), Dorsal Root Ganglion system (DRG), or implantable infusion pump.
    • Subject is currently participating in another clinical investigation with an active treatment arm.
    • Subject unable to read and/or write.