NEUROCUPLE™ in TKA Patients to Enhance Pain Management

Launched by NCAP MEDICAL · Jun 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new pain management device called NEUROCUPLE™ for patients undergoing total knee replacement surgery, also known as total knee arthroplasty (TKA). The goal is to see if wearing the NEUROCUPLE™ patch for 30 days can help reduce pain and the need for opioids, which are strong pain medications that can have side effects. Participants will be randomly assigned to either receive the active device or a similar-looking placebo device that does not have the pain-relieving features. This way, researchers can accurately measure how well the NEUROCUPLE™ works.

To join this study, participants need to be at least 18 years old and scheduled for their first knee replacement surgery. They should not have severe anxiety, depression, or other conditions that would make their recovery complicated. Throughout the trial, participants can expect regular check-ins to monitor their pain levels and overall recovery. It’s important to note that this study is currently recruiting participants, and it aims to provide valuable information that could lead to a new, effective way to manage pain after knee surgery without relying on opioids.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • \>18 years of age
• • Scheduled for elective primary unilateral TKA
• • T-score \< 60 on the PROMIS Anxiety measure
• Exclusion Criteria:
• • Children (\<18 yr.)
• • Pregnant women
• • Active alcoholism (defined as daily use of more than 1 liter of wine and /or 3 or more shots of hard liquor) or drug abuse (defined as daily use of illicit drugs)
• • Severe chronic pain condition that requires daily preoperative opioid dependence
• • T-score ≥ 60 in any of the three PROMIS measures (i.e., sleep, anxiety, and depression)
• • Other concomitant surgery being performed in addition to TKA
• • Patients undergoing bilateral TKA
• • Patients undergoing knee replacement revision
• • Patients with limited mobility (in a wheelchair or requiring a walker)
• • Patients who are not returning home after surgery