RecruitingACTRN12618000721202

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


Sponsor

Vincent Galan, MD

Enrollment

20 participants

Start Date

Mar 7, 2018

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Spinal cord stimulation (SCS) is an established treatment for chronic back and leg pain, particularly in people who have had back surgery that didn't fully relieve their pain — a condition called "failed back surgery syndrome." It works by delivering gentle electrical pulses to the spinal cord through implanted leads, interrupting pain signals before they reach the brain. Two different electrical patterns are currently available: High Density stimulation and BURST stimulation, both of which have been shown to reduce pain, but they haven't been directly compared head-to-head. This study is running a direct comparison of the two approaches in people who are candidates for SCS, to find out which one works better for managing chronic back and leg pain. Participants will try both patterns and the results will be measured objectively. You may be eligible if you are 18 or older, have chronic back and leg pain rated at least 5 out of 10 on a pain scale, are a candidate for spinal cord stimulation, and are willing to attend study visits and not increase your pain medications during the trial period. People who have previously had an SCS device or similar implant, or who have significant unresolved psychological or legal issues related to their pain, may not be eligible. This could be an opportunity to access SCS therapy while contributing to evidence about which approach works best.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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) stim

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)

GEORGIA, United States of America

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