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Randomized Controlled Trial
A pilot study comparing algorithmic adaptive conventional stimulation to high dose stimulation in chronic pain patients.
- Tessa Harland, Michael Gillogly, Olga Khazen, Avi A Gajjar, Melisande Nabage, Frank Trujillo, Marisa DiMarzio, and Julie G Pilitsis.
- Department of Neurosurgery, Albany Medical College, Albany, New York, USA.
- World Neurosurg. 2022 Nov 1; 167: e871e876e871-e876.
IntroductionSpinal cord stimulation is an effective method of treatment for chronic pain. We previously showed that programming using accelerometry was advantageous for paresthesia-based stimulation. However, programming can be labor intensive.ObjectiveHere we focus on standardized programming for both accelerometer-based paresthesia-induced programming (termed "shuffle") and high-dose (HD) subthreshold programming with stimulation delivered over the T9-10 interspace.MethodsIn this prospective cross-over study, patients received 4 weeks of shuffle programming and 4 weeks of HD programming in a randomized order. In both intervals, contacts overlying T9-10 were programmed. Pain scales with measurements of activity and sleep were collected at the end of each study arm and compared with preoperative baseline scores.ResultsTwelve patients were enrolled, with 10 patients completing this study. Compared with baseline, during the HD study period, significant improvements were seen in worst pain of week (P = 0.03) and current pain (P = 0.04) as rated on Numeric Rating Scale scores and walking on the Activity Test (P = 0.012). No difference was seen from baseline compared with shuffle stimulation or in shuffle stimulation compared with HD stimulation.ConclusionIn this pilot study, we demonstrated that HD stimulation at T9-10 is superior to algorithmic programming of paresthesia-based stimulation. These results compared with our previous work with shuffle suggest that paresthesia-based stimulation may necessitate stimulation of additional contact locations and additional programming to optimize. This algorithmic programming of paresthesia-based stimulation continues to warrant exploration.Copyright © 2022 Elsevier Inc. All rights reserved.
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