• Mehul J Desai, Tejal Raju, Chheany Ung, Sailesh Arulkumar, Leo Kapural, Mayank Gupta, Kasra Amirdelfan, David Rosenfeld, Aaron Calodney, Dawood Sayed, Ajay Antony, Sean Li, Ramana Naidu, Joel Ackerman, Robert Ball, Michael Fishman, Peter Staats, Gary Heit, Shilpa Kottalgi, and James Makous.
• International Spine, Pain & Performance Center, Washington, DC; George Washington University, School of Medicine & Health Sciences, Washington, DC.
• Pain Physician. 2023 Nov 1; 26 (7): 575584575-584.

BackgroundChronic, intractable, neuropathic pain is readily treatable with spinal cord stimulation (SCS). Technological advancements, including device miniaturization, are advancing the field of neuromodulation.ObjectivesWe report here the results of an SCS clinical trial to treat chronic, low back and leg pain, with a micro-implantable pulse generator (micro-IPG).Study DesignThis was a single-arm, prospective, multicenter, postmarket, observational study.SettingPatients were recruited from 15 US-based comprehensive pain centers.MethodsThis open-label clinical trial was designed to evaluate the performance of the Nalu™ Neurostimulation System (Nalu Medical, Inc., Carlsbad, CA) in the treatment of low back and leg pain. Patients, who provided informed consent and were successfully screened for study entry, were implanted with temporary trial leads. Patients went on to receive a permanent implant of the leads and micro-IPG if they demonstrated a >= 50% reduction in pain during the temporary trial period. Patient-reported outcomes (PROs), such as pain scores, functional disability, mood, patient impression of change, comfort, therapy use profile, and device ease of use, were captured.ResultsAt baseline, the average pain Visual Analog Scale (VAS) score was 72.1 ± 17.9 in the leg and 78.0 ± 15.4 in the low back. At 90 days following permanent implant (end of study), pain scores improved by 76% (VAS 18.5 ± 18.8) in the leg and 75% (VAS 19.7 ± 20.8) in the low back. Eighty-six percent  of both leg pain and low back pain patients demonstrated a >= 50% reduction in pain at 90 days following implant. The comfort of the external wearable (Therapy Disc and Adhesive Clip) was rated 1.16 ± 1.53, on average, at 90 days on an 11-point rating scale (0 = very comfortable, 10 = very uncomfortable). All PROs demonstrated statistically significant symptomatic improvement at 90 days following implant of the micro-IPG.Limitations  Limitations of this study include the lack of long-term results (beyond 90 days) and a relatively small sample size of 35 patients who were part of the analysis; additionally, there was no control arm or randomization as this was a single-arm study, without a comparator, designed to document the efficacy and safety of the device. Therefore, no direct comparisons to other SCS systems were possible.ConclusionsThis clinical study demonstrated profound leg and low back pain relief in terms of overall pain reduction, as well as the proportion of therapy responders. The study patients reported the wearable aspects of the system to be very comfortable.

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