Journal of Pain Research (Mar 2022)
60-Day PNS Treatment May Improve Identification of Delayed Responders and Delayed Non-Responders to Neurostimulation for Pain Relief
Abstract
Ramana Naidu,1 Sean Li,2 Mehul J Desai,3,4 Samir Sheth,5 Nathan D Crosby,6 Joseph W Boggs6 1California Orthopedics & Spine, Larkspur, CA, USA; 2Premier Pain Centers, Shrewsbury, NJ, USA; 3International Spine Pain & Performance Center, Washington, DC, USA; 4George Washington University, School of Medicine and Health Sciences, Washington, DC, USA; 5Sutter Roseville Pain Management, Roseville, CA, USA; 6SPR Therapeutics, Cleveland, OH, USACorrespondence: Ramana Naidu, California Orthopedics & Spine, 2 Bon Air Road #120, Larkspur, CA, 94939, USA, Tel +1 608-695-7266, Email [email protected]: Conventional neurostimulation typically involves a brief (eg, ≤ 10-day) trial to assess presumed effectiveness prior to permanent implantation. Low trial conversion rates and high explant rates due to inadequate pain relief highlight the need for improved patient identification strategies. The development of a 60-day percutaneous peripheral nerve stimulation (PNS) system enables evaluation of outcomes following an extended temporary treatment period of up to 60 days, that may obviate or validate the need for permanent implant. The present study provides the first real-world evidence regarding patient response throughout a 60-day PNS treatment period.Methods: Anonymized data listings were compiled from patients who underwent implantation of temporary percutaneous leads and opted-in to provide real-world data to the device manufacturer during routine interactions with device representatives throughout the 60-day treatment.Results: Overall, 30% (222/747) of patients were early responders (≥ 50% pain relief throughout treatment). Another 31% (231/747) of patients initially presented as non-responders but surpassed 50% pain relief by the end of treatment. Conversely, 32% (239/747) of patients were non-responders throughout treatment. An additional 7% (55/747) of patients initially presented as responders but fell below 50% relief by the end of the treatment period.Conclusion: An extended, 60-day PNS treatment may help identify delayed responders, providing the opportunity for sustained relief and improving access to effective PNS treatment. Compared to a conventionally short trial of ≤ 10 days, a longer 60-day PNS treatment may also help reduce explant rates by identifying delayed non-responders unlikely to benefit long-term. These scenarios support the importance of an extended 60-day temporary PNS stimulation period to help inform stepwise treatment strategies that may optimize outcomes and cost-effectiveness.Keywords: peripheral nerve stimulation, neuromodulation, 60-day PNS, chronic pain, real-world evidence
