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Behavioural Intervention

NEUROCUPLE™ Patch for Total Knee Replacement

N/A
Recruiting
Led By Jacques E. Chelly, MD, PhD, MBA
Research Sponsored by nCap Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
>18 years of age
Scheduled for elective primary unilateral TKA
Must not have
Children (<18 yr.)
Severe chronic pain condition that requires daily preoperative opioid dependence
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24-hours post-operatively

Summary

This trial is testing a patch called NEUROCUPLE™ to see if it can help reduce pain and opioid use after knee replacement surgery. The goal is to show that the patch is a safe and

Who is the study for?
This trial is for individuals who have undergone total knee replacement surgery and are looking to manage postoperative pain without relying on opioids. Participants should be willing to use the NEUROCUPLE™ patch or a placebo for 30 days.
What is being tested?
The study tests the NEUROCUPLE™ patch, which is designed to reduce pain after knee surgery, against a placebo. It's randomized, meaning people get either the real patch or a fake one by chance in equal numbers.
What are the potential side effects?
Since this summary doesn't provide specific side effects of the NEUROCUPLE™ patch, we can assume they might include skin irritation at the site of application or other mild reactions typical of topical treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18.
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I am scheduled for my first knee replacement surgery on one knee.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 18 years old.
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I need opioids daily due to severe chronic pain.
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I am having another surgery besides my knee replacement.
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I am having knee replacement surgery on both knees.
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I am having a knee replacement revision.
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I use a wheelchair or walker for mobility.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~prior to day of surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to day of surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Baseline pain at rest
Opioid prescriptions within the first 6-weeks following surgery
Post-operative pain at rest
Secondary study objectives
Pain while walking 100 feet, 1-week post-op
Pain while walking 100 feet, 2-weeks post-op
Pain while walking 100 feet, 24-hours post-op
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: NEUROCUPLE™ GroupExperimental Treatment1 Intervention
This arm of subjects will receive the active NEUROCUPLE™ patch to wear for 2-weeks following their TKA surgery.
Group II: Placebo GroupPlacebo Group1 Intervention
This arm of subjects will receive the placebo (non-active, sham) patch to wear for 2-weeks following their TKA surgery.

Find a Location

Who is running the clinical trial?

nCap MedicalLead Sponsor
2 Previous Clinical Trials
149 Total Patients Enrolled
University of PittsburghOTHER
1,789 Previous Clinical Trials
16,359,483 Total Patients Enrolled
Jacques E. Chelly, MD, PhD, MBAPrincipal InvestigatorUniversity of Pittsburgh / UPMC
1 Previous Clinical Trials
10 Total Patients Enrolled
~93 spots leftby Sep 2025
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