Role of the NeuroCuple? Device for the Postoperative Pain Management of Patients Undergoing Unilateral Primary Total Knee and Hip Arthroplasty: A Pilot Prospective, Randomized, Open-Label Study

Background: The potential effectiveness of the non-pharmacological and nanotechnology-based NeuroCuple (TM) device in reducing postoperative surgical pain and opioid consumption remains unknown. Methods: This randomized controlled open-label study was conducted in patients undergoing a primary unilateral total knee or total hip arthroplasty. In the recovery room, patients were randomized to receive either standard of care (control group) or standard of care plus two NeuroCuple (TM) devices. The outcome variables included pain and opioid consumption (oral morphine equivalent, OME in milligrams). Results: A total of 69 patients were randomized to either the NeuroCuple (TM) group (n = 38) or the control group (n = 31). Use of the NeuroCuple (TM) devices was associated with a significant 34% reduction in pain at rest (means of area under the curve: 6.3 vs. 9.5; p = 0.018) during postoperative days 1-3. Opioid consumption was reduced by 9%. More importantly, use of the NeuroCuple (TM) devices reduced the number of patients requesting an opioid prescription following discharge from the hospital by 52% (26% vs. 55%, p = 0.016). Conclusions: Our data suggest that the NeuroCuple (TM) device may be an effective non-pharmacological alternative to opioids to manage postoperative pain following unilateral arthroplasty due to its ability to reduce postoperative opioid use.