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

140 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

Research Team

Jacques E. Chelly, MD, PhD, MBA

Principal Investigator

University of Pittsburgh / UPMC

Amy Monroe, MPH, MBA

Principal Investigator

University of Pittsburgh / UPMC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

References

1. United States 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. [2020]

2. England pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

Capsaicin 8% patch reversibly reduces A-delta fiber evoked potential amplitudes. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Capsaicin 8% for Peripheral Neuropathic Pain Treatment: A Retrospective Cohort Study. [2022]

5. England 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. [2018]