The National Institute on Drug Abuse (NIDA) has granted funding to the company nCAP Medical to study a non-invasive, opioid-sparing device called NEUROCUPLE™ for pain management following total knee arthroplasty (TKA). The award will fund a randomized, placebo-controlled study to be conducted by Jacques E. Chelly, MD, PhD, MBA, and Senthil Sadhasivam, MD, MPH, MBA, FASA, as principal investigators. The study will aim to assess the potential role of the NEUROCUPLE™ as an opioid-sparing approach for postoperative pain management, which has been recognized as a significant public health issue.
Over 1 million TKAs are performed annually, and by 2030, the number of these procedures is expected to exceed 3 million annually. Currently, 90% of patients experience postoperative pain, and 80% use opioids for pain control. Postoperative pain management often results in excessive opioid use that leads to the risk of delayed recovery, opioid use disorder, and associated risk of opioid overdose and death. There is a critical need for alternative, non-opioid therapies for postoperative pain management.
Preliminary data collected by Drs. Chelly and Sadhasivam’s team suggests that the NEUROCUPLE™ device, which is based on the use of nanocapacitors, may represent a non-pharmacologic, non-opioid approach to reduce postoperative pain and opioid consumption while facilitating functional recovery. Preliminary data from the pilot study showed that the NEUROCUPLE™ device reduced opioid refills by 47% in the first 30 days post-surgery.
The newly funded NIDA phase I project will involve 120 patients in a randomized, placebo-controlled clinical trial to evaluate the device's effectiveness. Patients will be assigned to either the NEUROCUPLE™ group or a placebo group, with the device applied over the knee for two weeks following surgery. All patients will receive standard perioperative care.
The primary endpoints of the study are the amount of opioid required to control pain following surgery and the level of pain within the first six weeks. Secondary endpoints include pain while walking, time to discharge from the hospital, functional recovery, and patient satisfaction. Successful completion of this phase I program is expected to serve as the basis for a phase II program based on a multicentric study including a larger number of patients. The ultimate goal of this work is to obtain FDA approval and payor reimbursements for the use of the NEUROCUPLE™ device as an effective opioid sparing technique for pain-related musculoskeletal disorders.