NEUROCUPLE™ Patch for Pain After Oral Surgery

AL
Overseen ByAmy L Monroe
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 patch called NEUROCUPLE™ to determine if it can reduce pain and decrease the need for opioids after wisdom teeth removal. Participants will receive either the active patch or a placebo patch that looks identical but is inactive. The trial seeks healthy individuals scheduled for the removal of partially or fully impacted wisdom teeth. As an unphased trial, this study provides a unique opportunity to contribute to innovative pain management research.

What prior data suggests that the NeuroCuple device is safe for pain relief after oral surgery?

Research shows that the NeuroCuple™ patch offers a promising way to manage pain after oral surgery, such as wisdom teeth removal. Studies have found that this patch effectively reduces pain and decreases the need for opioids, which often have serious side effects. In one study, patients using a similar patch reported no negative effects, suggesting that the NeuroCuple™ patch is well-tolerated.

The patch employs nanotechnology, using very tiny materials to enhance treatment. Previous research found that the NeuroCuple™ patch reduced pain levels by about 34% without causing major side effects. This suggests it is a safe option for managing post-surgery pain without relying on medications.12345

Why are researchers excited about this trial?

The NEUROCUPLE™ Patch is unique because it offers a non-invasive, localized treatment option for managing pain after oral surgery, specifically wisdom teeth extraction. Unlike standard treatments like oral pain medications, which can affect the entire body and sometimes lead to unwanted side effects, the NEUROCUPLE™ Patch targets pain directly at the site of surgery. Researchers are excited about this treatment as it promises to reduce pain without the systemic effects of traditional painkillers, potentially offering a safer and more comfortable recovery experience.

What evidence suggests that the NEUROCUPLE™ Patch is effective for pain relief after oral surgery?

Research has shown that the NEUROCUPLE™ Patch, which participants in this trial may receive, might help ease pain after wisdom teeth removal. Studies also suggest it could reduce the need for opioid painkillers, commonly prescribed after such surgeries. The patch employs a special technology to target pain directly, potentially providing relief without drug side effects. Users of similar devices reported feeling less pain and recovering faster. Although more research is needed, early results are promising for those seeking alternative pain management methods.12356

Who Is on the Research Team?

DH

Daniel Hawkins, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

Inclusion Criteria

3. Healthy based on medical history
5. Able to understand and sign the informed consent form
6. Willing and able to comply with all study procedures
See 5 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 or sham device for 2 days following wisdom teeth extraction

2 days
1 visit (in-person) for device application

Follow-up

Participants are monitored for pain, opioid use, and other outcomes post-extraction

3 months
Follow-up via REDCap surveys on days 1, 7, 30, and 90 post-extraction

What Are the Treatments Tested in This Trial?

Interventions

  • NEUROCUPLE™ Patch

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: NEUROCUPLE™ GroupExperimental Treatment1 Intervention
Group II: Sham 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+

Citations

NeuroCuple to Mitigate Post-Wisdom Teeth Extraction Opioid ...

The primary objectives are to determine whether the active NeuroCuple reduces postoperative pain and decreases opioid consumption compared to a ...

NeuroCuple to Mitigate Post-Wisdom Teeth Extraction ...

The primary objectives are to determine whether the active NeuroCuple reduces postoperative pain and decreases opioid consumption compared to a sham (placebo) ...

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

Therefore, we hypothesized that the NeuroCuple™ device might potentially reduce postoperative pain and opioid consumption in patients undergoing ...

Reducing Pain From Wisdom Molar Extractions

The investigators found that the TMNB relieved jaw pain stemming from these muscles, in a quick and sustained manner, even in patients whose pain following ...

Nanotechnology for Pain Management - PMC - NIH

This study suggested that compared to baseline, the application of a nanocapacitor-based Kailo™ pain relief patch on the pain site for 30 days ...

Non-Opioid Pain Management Options After Oral Surgery

How effective is aspirin for oral surgery pain? Aspirin can help, but it is usually less effective than ibuprofen for surgical dental pain.