COMPLETED

NEUROCUPLE™ in TKA Patients to Enhance Pain Management

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a randomized (1:1) placebo-controlled clinical trial to determine the feasibility and effectiveness of 30-day application of NEUROCUPLE™ patch for pain reduction and opioid consumption following TKA. Results will establish NEUROCUPLE™ as an effective non-opioid postoperative pain management device for FDA approval. Importantly, we have a placebo device (device without the captor array layer) that looks exactly like the active device, allowing us to conduct a true placebo randomized study.

Official Title

Enhancing Pain Management for Knee Replacement Patients Through an Innovative Non-invasive and Opioid-sparing Device (NEUROCUPLE™)

Quick Facts

Study Start:2024-09-25
Study Completion:2025-07-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06460350

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * \>18 years of age
  2. * Scheduled for elective primary unilateral TKA
  3. * T-score \< 60 on the PROMIS Anxiety measure
  1. * Children (\<18 yr.)
  2. * Pregnant women
  3. * 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)
  4. * Severe chronic pain condition that requires daily preoperative opioid dependence
  5. * T-score ≥ 60 in any of the three PROMIS measures (i.e., sleep, anxiety, and depression)
  6. * Other concomitant surgery being performed in addition to TKA
  7. * Patients undergoing bilateral TKA
  8. * Patients undergoing knee replacement revision
  9. * Patients with limited mobility (in a wheelchair or requiring a walker)
  10. * Patients who are not returning home after surgery

Contacts and Locations

Principal Investigator

Jacques E. Chelly, MD, PhD, MBA
PRINCIPAL_INVESTIGATOR
University of Pittsburgh / UPMC
Amy Monroe, MPH, MBA
STUDY_DIRECTOR
University of Pittsburgh / UPMC

Study Locations (Sites)

UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
United States

Collaborators and Investigators

Sponsor: nCap Medical

  • Jacques E. Chelly, MD, PhD, MBA, PRINCIPAL_INVESTIGATOR, University of Pittsburgh / UPMC
  • Amy Monroe, MPH, MBA, STUDY_DIRECTOR, University of Pittsburgh / UPMC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-25
Study Completion Date2025-07-18

Study Record Updates

Study Start Date2024-09-25
Study Completion Date2025-07-18

Terms related to this study

Additional Relevant MeSH Terms

  • Total Knee Arthroplasty