To evaluate the effectiveness of two (2) different waveforms of Spinal Cord Stimulation in a population of patients with back and leg pain due to failed back surgery syndrome
Vincent Galan, MD
20 participants
Mar 7, 2018
Interventional
Conditions
Summary
To evaluate the efficacy in a head to head comparison of 2 currently available waveforms High Density (HD) versus BURST programming options in SCS for the management of chronic, intractable pain of the trunk and limbs due to failed back surgery syndrome.
Eligibility
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Interventions
All eligible subjects will undergo an SCS Device Trial that includes an intraoperative and programming trial chosen at random between a Burst ( 40 Hz, 1000 µsec) stimulation and High Density (HD) stimulation (1000 Hz and 90 µsec) waveform at subthreshold levels. Total of 20 subjects will be enrolled. The initial system will be chosen at random between BURST and HD. Total trial will be 10 days divided in the following way: Procedure trial will be done and leads placed. This is day 0. In days 1 and 2 (the initial 48 hours post-trial) no stimulation will be done to help patient recover from post-procedural pain. Then day 3, then the first company which was chosen at random will have a 3-days of trial (days 3, 4 and 5) followed by a two-day washout (days 6 and 7) period, and then a 3-day trial (days 8, 9 and 10) with the second system. Subjects experiencing a positive response to either HD stimulation or BURST during this trial, defined as a subject-reported assessment with equal or greater 50% improvement in overall pain (trunk and limb) from baseline, will move forward with a permanent implant. The patient will decide which systems they prefer and why. Those not reporting a positive response (less than 50% pain relief) during the trial will be exited from the study. If the patient is initially enrolled in the Programming trial. HD stimulation will be programmed for pain relief and comfort at 1000 Hz and 90 µsec. After a successful programming trial, with either of the two systems, patient will be scheduled for implant of a permanent system. The subjects will receive an permanent implant with either the Medtronic Intellis Platform SureScan MRI Rechargeable neurostimulator or the the Prodigy MRI™ Implantable Pulse Generator. Two weeks after permanent placement, if pain relief is inadequate (VAPS less than 50%) during a continuous period of more than 2 weeks, without migration, the patient may change from HD or BURST to Low Density (LD). The purpose is to achieve equal to or greater than 50% pain relief. Approximately 9-12 days post-implant after the wound has healed, the device will be activated and programmed to the parameters that were successful at trialing.
Locations(1)
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ACTRN12618000721202