NeuroCuple® Clinical Trial for Knee Replacement Pain Management | NCT06460350

ClinicalTrials.gov · NCT06460350 · Orthopedic Recovery Research

NeuroCuple® Clinical Trial Advances Drug-Free Pain Management Following Knee Replacement Surgery

The NCT06460350 clinical trial evaluated the NeuroCuple® device as a non-invasive, opioid-sparing approach for post-operative pain management in total knee arthroplasty patients.

Understanding the Clinical Trial

Total knee arthroplasty (TKA) is one of the most common orthopedic surgeries performed worldwide. Although these procedures often restore mobility and quality of life, post-operative pain management remains a major clinical challenge.


Many patients recovering from knee replacement surgery rely heavily on opioid medications during rehabilitation and recovery. This has created significant interest in scalable, non-pharmacological approaches that may reduce opioid utilization while still supporting recovery outcomes.


The NCT06460350 clinical trial was designed to evaluate whether the NeuroCuple® device could help reduce post-operative pain and opioid consumption following total knee arthroplasty. 

Trial Design and Study Structure

The study was designed as a randomized controlled clinical trial evaluating post-operative application of the NeuroCuple® patch in TKA patients.

  • Randomized controlled design
  • Total knee arthroplasty patient population
  • Evaluation of opioid utilization after surgery
  • Evaluation of post-operative pain reduction
  • Two-week to thirty-day recovery evaluation period
  • University of Pittsburgh / UPMC clinical collaboration
  • ClinicalTrials.gov identifier: NCT06460350
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Why Opioid-Sparing Recovery Matters

Post-surgical pain management remains one of the largest contributors to opioid exposure following orthopedic procedures.


According to study descriptions associated with the NeuroCuple® research program, a significant percentage of patients undergoing total knee arthroplasty receive opioid prescriptions following surgery. 


Healthcare systems globally continue searching for alternatives that may:

Reduce Opioid Exposure Supporting pain management while potentially reducing dependence on opioid medications during recovery.
Improve Functional Recovery Helping patients remain mobile and engaged in rehabilitation after surgery.
Expand Non-Drug Options Building scalable approaches that do not rely entirely on pharmaceuticals.
Reduce System Burden Supporting lower-cost, distributed recovery models that can scale across healthcare systems.

What Makes NeuroCuple® Different

NeuroCuple® technology is described as a passive bioelectrical interface designed to interact with the body’s natural electrical environment without delivering powered electrical stimulation. 


The technology differs from conventional powered stimulation systems because it:

  • Requires no batteries or charging
  • Does not deliver electrical shocks or powered stimulation
  • Uses no pharmaceuticals or consumables
  • Can be reused over extended durations
  • Functions as a non-invasive external interface

Institutional and Research Collaboration

The NeuroCuple® TKA research program involved collaboration with researchers affiliated with the University of Pittsburgh and UPMC. 


Additional NIH and NIDA-supported research initiatives associated with the broader NeuroCuple® orthopedic recovery program reflect increasing institutional interest in scalable non-opioid pain management approaches. 

Why This Research Could Matter Globally

Pain-related disability remains one of the leading causes of reduced participation and healthcare utilization worldwide.


Technologies that may support recovery while reducing pharmaceutical burden could have implications far beyond orthopedic surgery alone.


Potential future applications include:

  • Post-operative recovery pathways
  • Distributed rehabilitation support
  • Community-based recovery programs
  • Low-resource healthcare environments
  • Scalable public health pain initiatives
  • Population-scale pain management strategies

Published Research and Clinical Progress

The clinical trial program has contributed to the growing body of evidence evaluating NeuroCuple® technology in orthopedic recovery settings.


Related published orthopedic research examining postoperative pain management and opioid reduction outcomes has now appeared in peer-reviewed literature, helping expand the evidence base for scalable drug-free pain management technologies. 

Explore Clinical Evidence & Research

Explore the Official Clinical Trial Listing

Full details regarding study design, enrollment criteria, endpoints, and institutional collaboration are available through ClinicalTrials.gov.

View NCT06460350
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