NEUROCUPLE™ in TKA Patients to Enhance Pain Management

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.

Conditions

Total Knee Arthroplasty

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Study Overview

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Study Details

Study overview

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.

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

NEUROCUPLE™ in TKA Patients to Enhance Pain Management

Condition
Total Knee Arthroplasty
Intervention / Treatment

-

Contacts and Locations

Pittsburgh

UPMC Shadyside Hospital, Pittsburgh, Pennsylvania, United States, 15232

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * \>18 years of age
  • * Scheduled for elective primary unilateral TKA
  • * T-score \< 60 on the PROMIS Anxiety measure
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2026-09-30