NEUROCUPLE™ Patch for Total Knee Replacement

Overseen By Carly Riedmann, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: nCap Medical

Must not be taking: Opioids, Illicit drugs

Disqualifiers: Pregnancy, Alcoholism, Limited mobility, others

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of the NEUROCUPLE™ patch in reducing pain and lowering opioid use after knee replacement surgery. Participants will receive either the active patch or a placebo (a lookalike patch without active ingredients) for two weeks post-surgery. The goal is to determine if this patch can manage pain without opioids. Individuals scheduled for knee replacement who do not heavily rely on opioids may be suitable candidates. As an unphased trial, this study allows participants to contribute to innovative pain management research.

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 prior data suggests that the NEUROCUPLE™ patch is safe for postoperative pain management?

Research shows that the NEUROCUPLE™ patch might be a safe option for managing pain after knee surgery. Previous studies found that patients who underwent total knee replacement tolerated the patch well. In a small study with 60 patients, no major safety issues were reported.

The patch aims to reduce pain and lessen the need for opioids, which are strong painkillers with potential side effects. So far, there have been no significant reports of negative side effects from using the NEUROCUPLE™ patch. This suggests it is safe for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the NEUROCUPLE™ Patch because it offers a new approach to managing post-surgical pain following total knee replacement (TKA). Unlike traditional pain management options like oral medications or injections, the NEUROCUPLE™ Patch provides localized treatment directly at the site of surgery. This targeted delivery method could potentially reduce systemic side effects and enhance recovery by focusing the pain relief where it is needed most. Additionally, the patch's ease of use and non-invasive nature may improve patient compliance and comfort during the critical recovery period.

What evidence suggests that the NEUROCUPLE™ patch is effective for pain reduction after total knee replacement?

Research shows that the NEUROCUPLE™ patch might effectively manage pain without opioids after knee surgery. In this trial, participants in the NEUROCUPLE™ Group will receive the active patch, while those in the Placebo Group will receive a non-active, sham patch. Early results from previous studies found that the NEUROCUPLE™ patch reduced the need for opioid refills by 47% in the first month after surgery. This suggests the patch can control pain and lessen reliance on pain medications. Other reported benefits include less overall pain, a better quality of life, and shorter hospital stays. These findings suggest that NEUROCUPLE™ could be a promising option for managing pain after knee replacement surgery. ^{1 2 4 6 7}

Who Is on the Research Team?

Jacques E. Chelly, MD, PhD, MBA

Principal Investigator

University of Pittsburgh / UPMC

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)

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?

Group I: NEUROCUPLE™ Group Experimental Treatment 1 Intervention

This arm of subjects will receive the active NEUROCUPLE™ patch to wear for 2-weeks following their TKA surgery.

Group II: Placebo Group Placebo Group 1 Intervention

This arm of subjects will receive the placebo (non-active, sham) patch to wear for 2-weeks following their TKA surgery.

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Capsaicin 8% patch reversibly reduces A-delta fiber evoked potential amplitudes. Papagianni, A., Siedler, G., Sommer, C., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adlea (ALGRX-4975), an injectable capsaicin (TRPV1 receptor agonist) formulation for longlasting pain relief. Remadevi, R., Szallisi, A.[2013]

The capsaicin 8% patch significantly reduced pain intensity in patients with chronic neuropathic pain, with median pain scores dropping from 6 to 3 on a scale of 0-10, indicating effective symptom relief.

Patients also experienced a notable reduction in the painful treatment area, demonstrating the patch's efficacy in managing peripheral neuropathic pain, with high treatment compliance and good tolerability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Capsaicin 8% for Peripheral Neuropathic Pain Treatment: A Retrospective Cohort Study. Vieira, IF., de Castro, AM., Loureiro, MDC., et al.[2022]

In a study of 412 patients with non-diabetes-related peripheral neuropathic pain, the capsaicin 8% patch led to a significant 26.6% reduction in average daily pain scores within 8 weeks, demonstrating effective pain relief.

The treatment was well tolerated, with most adverse events being mild or moderate, and 44% of patients experienced a meaningful pain response, which was sustained for up to 52 weeks, indicating long-term efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of the capsaicin 8% patch in the management of peripheral neuropathic pain in European clinical practice: the ASCEND study. Mankowski, C., Poole, CD., Ernault, E., et al.[2018]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06460350

NEUROCUPLE™ in TKA Patients to Enhance Pain ...

This is a randomized (1:1) placebo-controlled clinical trial to determine the feasibility and effectiveness of 30-day application of NEUROCUPLE™ patch for ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10707685/

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

Conclusions: Our data suggest that the NeuroCuple™ device may be an effective non-pharmacological alternative to opioids to manage postoperative ...

3.

reporter.nih.gov

reporter.nih.gov/project-details/10921429

Enhancing pain management for knee replacement patients through ...

Preliminary data from a pilot study with 60 patients undergoing TKA demonstrated that the NEUROCUPLE device reduced opioid refills in the first 30 postoperative ...

4.

anesthesiology.pitt.edu

anesthesiology.pitt.edu/news/nida-funds-investigation-innovative-device-enhance-pain-management-knee-surgery

NIDA Funds Investigation of Innovative Device to Enhance ...

Preliminary data from the pilot study showed that the NEUROCUPLE™ device reduced opioid refills by 47% in the first 30 days post-surgery. The newly funded NIDA ...

5.

app.trialscreen.org

app.trialscreen.org/trials/neurocuple-tka-patients-trial-nct06460350

NEUROCUPLE™ in TKA Patients to Enhance Pain ...

Potential benefits include reduced postoperative pain, decreased need for opioid medications, improved quality of life, and shorter hospital stays. Participants ...

6.

reporter.nih.gov

reporter.nih.gov/search/5fUA-zM3bUSQFDS6k-2SQA/project-details/10921429

RePORT ⟩ RePORTER - National Institutes of Health (NIH) |

... (NEUROCUPLE™) for patients undergoing TKA. Preliminary data from a pilot study with 60 patients undergoing TKA demonstrated that the NEUROCUPLE device ...

7.

withpower.com

withpower.com/trial/phase-total-knee-arthroplasty-tka-5-2024-a06fc

NEUROCUPLE™ Patch for Total Knee Replacement

This N/A medical study run by nCap Medical is evaluating whether NEUROCUPLE™ Patch will have tolerable side effects & efficacy for patients with Total Knee ...