140 Participants Needed

NEUROCUPLE™ Patch for Total Knee Replacement

AS
CR
Overseen ByCarly Riedmann, MPH

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What makes the NEUROCUPLE™ Patch treatment unique for total knee replacement?

The NEUROCUPLE™ Patch is unique because it may incorporate elements similar to capsaicin-based treatments, which are known for providing long-lasting pain relief by desensitizing pain-conducting neurons, potentially offering a novel approach compared to standard pain management options after knee replacement surgery.12345

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 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.

Inclusion Criteria

I am older than 18.
I am scheduled for my first knee replacement surgery on one knee.

Exclusion Criteria

I am having knee replacement surgery on both knees.
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)
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the NEUROCUPLE™ patch or placebo patch for 2 weeks following TKA surgery

2 weeks
1 visit (in-person) for surgery, followed by patch application

Follow-up

Participants are monitored for pain reduction and opioid consumption post-surgery

6 weeks
Regular follow-up assessments at 1-week, 2-weeks, and 6-weeks post-discharge

Long-term Follow-up

Participants are monitored for long-term opioid use and pain management outcomes

Additional 4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • NEUROCUPLE™ Patch
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: NEUROCUPLE™ GroupExperimental Treatment1 Intervention
Group II: Placebo GroupPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

nCap Medical

Lead Sponsor

Trials
3
Recruited
290+

University of Pittsburgh

Collaborator

Trials
1,820
Recruited
16,360,000+

Published Research Related to This Trial

Fasinumab, an anti-nerve growth factor monoclonal antibody, significantly reduced pain and improved physical function in patients with moderate-to-severe osteoarthritis (OA) of the hip and knee, with 342 out of 421 patients completing the 36-week study.
While fasinumab showed a favorable efficacy profile, there was a dose-dependent increase in arthropathies, with 7% of treated patients experiencing joint issues, suggesting that further research should focus on determining the safest effective dose.
The Efficacy, Tolerability, and Joint Safety of Fasinumab in Osteoarthritis Pain: A Phase IIb/III Double-Blind, Placebo-Controlled, Randomized Clinical Trial.Dakin, P., DiMartino, SJ., Gao, H., et al.[2020]
Adlea (ALRGX-4975), an injectable capsaicin formulation, has shown significant pain reduction in phase II clinical trials for patients after total knee arthroplasty and bunionectomy, as well as for those with osteoarthritis and Morton's neuroma.
The mechanism of action involves desensitizing pain-conducting neurons, suggesting that Adlea could be a promising treatment for various chronic pain conditions, with phase III trials expected to start soon.
Adlea (ALGRX-4975), an injectable capsaicin (TRPV1 receptor agonist) formulation for longlasting pain relief.Remadevi, R., Szallisi, A.[2013]
The capsaicin 8% patch significantly reduces pain-related electrical responses in both healthy individuals and patients with neuropathic pain, indicating its efficacy in altering pain signaling mechanisms.
Patients who experience a reduction in pain-related responses after capsaicin application are more likely to benefit from pain relief, suggesting that specific sensory thresholds may serve as predictive biomarkers for treatment response.
Capsaicin 8% patch reversibly reduces A-delta fiber evoked potential amplitudes.Papagianni, A., Siedler, G., Sommer, C., et al.[2022]

Citations

The Efficacy, Tolerability, and Joint Safety of Fasinumab in Osteoarthritis Pain: A Phase IIb/III Double-Blind, Placebo-Controlled, Randomized Clinical Trial. [2020]
Adlea (ALGRX-4975), an injectable capsaicin (TRPV1 receptor agonist) formulation for longlasting pain relief. [2013]
Capsaicin 8% patch reversibly reduces A-delta fiber evoked potential amplitudes. [2022]
Capsaicin 8% for Peripheral Neuropathic Pain Treatment: A Retrospective Cohort Study. [2022]
Effectiveness of the capsaicin 8% patch in the management of peripheral neuropathic pain in European clinical practice: the ASCEND study. [2018]
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