NEUROCUPLE™ Patch for Knee Pain

Not yet recruiting at 2 trial locations
DA
JE
Overseen ByJacques E. Chelly, MD, PhD, MBA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Jacques E. Chelly
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the NEUROCUPLE patch to determine its effectiveness in reducing knee pain and the need for opioids after knee replacement surgery. Researchers aim to assess whether the patch can lessen pain while at rest on the first day after surgery and reduce opioid use during the same period. Participants will receive either the NEUROCUPLE patch or a look-alike placebo patch to wear for 7 days, with their pain levels and medication use monitored. The trial is suitable for adults scheduled for a single knee replacement surgery who do not have other major health issues or surgeries planned. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance post-surgical pain management.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have a severe chronic pain condition that requires daily opioid use, you may not be eligible to participate.

What prior data suggests that the NEUROCUPLE device is safe for reducing pain after knee surgery?

Research has shown that the NEUROCUPLE™ patch appears safe for managing pain after knee surgery. In an earlier study, patients who used the NEUROCUPLE™ patch for three days experienced no local side effects, suggesting it is well-tolerated for short-term use. Designed as a non-drug option for pain relief, it aims to help without the side effects associated with medications like opioids. Overall, findings indicate that the patch could be a safe alternative for managing knee pain without drugs.12345

Why are researchers excited about this trial?

The NEUROCUPLE™ Patch is unique because it introduces a non-invasive, localized method of pain management for knee pain following total knee arthroplasty (TKA). Unlike standard treatments like oral pain medications, which can have systemic side effects, this patch provides targeted relief directly at the site of pain. Researchers are excited about this treatment as it could reduce the need for opioids and their associated risks, offering a safer and potentially more effective option for managing post-surgical knee pain.

What evidence suggests that the NEUROCUPLE device is effective for reducing knee pain after surgery?

Research has shown that the NEUROCUPLE™ patch, which participants in this trial may receive, can help reduce pain after knee surgery. One study found that patients using the patch experienced 34% less pain while resting. Another study discovered that patients required 47% fewer opioid refills in the first 30 days after surgery. These findings suggest that the NEUROCUPLE™ patch could serve as a non-drug option to manage pain and reduce opioid use after knee replacement surgery.12367

Who Is on the Research Team?

JE

Jacques E. Chelly, MD, PhD, MBA

Principal Investigator

University of Pittsburgh / UPMC

AM

Amy Monroe, MPH, MBA

Principal Investigator

University of Pittsburgh / UPMC

Are You a Good Fit for This Trial?

This trial is for adults over 18 having their first knee replacement surgery on one knee. People can't join if they're pregnant, have severe chronic pain needing daily opioids, are not going home after surgery, have a history of drug or alcohol abuse, need another surgery at the same time, use a wheelchair or walker, or are getting both knees replaced.

Inclusion Criteria

I am over 18 years old.
I am scheduled for my first knee replacement surgery on one knee.

Exclusion Criteria

Patients who are not returning home after surgery
Pregnant women
Patients with active alcoholism or drug abuse
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants apply the NEUROCUPLE device or placebo device for 7 days following surgery

7 days
Daily monitoring through clinical records and patient reporting

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain and opioid use assessment

1 week
Assessments on postoperative Days 2 and 7

What Are the Treatments Tested in This Trial?

Interventions

  • NEUROCUPLE™

Trial Overview

The study tests whether the NEUROCUPLE™ patch can reduce pain and opioid use after knee replacement compared to a lookalike inactive (sham) patch. All participants also receive standard recovery care. Pain levels and opioid use will be tracked for seven days post-surgery.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: NEUROCUPLE™ GroupExperimental Treatment2 Interventions
Group II: Sham GroupPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jacques E. Chelly

Lead Sponsor

Trials
10
Recruited
710+

nCap Medical

Industry Sponsor

Trials
3
Recruited
290+

Citations

Role of the NeuroCuple™ Device for the Postoperative Pain ...

An observational study suggested that the NeuroCuple™ device may be effective in reducing pain associated with arthritis [12]. However, the ...

NEUROCUPLE™ as an Opioid Alternative Following Total ...

The goal of this clinical trial is to learn if the NEUROCUPLE device can reduce pain and opioid use after primary unilateral total knee arthroplasty (TKA) ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38068446/

Role of the NeuroCuple™ Device for the Postoperative ...

Use of the NeuroCuple™ devices was associated with a significant 34% reduction in pain at rest (means of area under the curve: 6.3 vs. 9.5; p = ...

NEUROCUPLE™ in TKA Patients to Enhance Pain ...

A pain relief patch that provides a clinically effective alternative to opioid use for pain management. The scientific premise of our proposal ...

NEUROCUPLE™ Patch for Total Knee Replacement

This trial aims to test the effectiveness of the NEUROCUPLE™ patch in reducing pain and lowering opioid use after knee replacement surgery.

Nanotechnology for pain management in orthopedic surgery

All EREM cohorts had substantially improved pain control at rest for up to 48 h post-surgery compared with placebo. No supplementary analgesia ...

Use of Nanotechnology as an Alternative to Opioids for Post ...

Our report suggests that the use of the NeuroCuple™ device may represent an interesting alternative to opioids for the peri-operative management of pain ...