This is a randomized (1:1), placebo-controlled clinical trial that will examine the feasibility and effectiveness of a 2-day application of the NeuroCuple device for pain relief and reduction of opioid use following 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) device. A total of 120 participants will be enrolled over a 1-year period and randomized to receive either the active device or an identical-appearing placebo device without the captor array layer.
This will be a triple-blind randomized (1:1) placebo-controlled clinical trial to determine the feasibility and effectiveness of a 2-days only 12-18h/day, mostly at night application of the NeuroCuple for reducing surgical pain and opioid use after third molar extraction. Study subjects, 18-40y, will be followed on days 1, 7, 1 month, and 3 months post-extraction via REDCap surveys with text, email, or phone reminders. Results will establish NeuroCuple as an effective non-opioid pain management approach for post-dental extraction pain. Importantly, a sham device that looks exactly like the active device will be implemented, allowing for a robust triple-blinded RCT. A prototype specific for this STTR's dental extraction indication has been designed, with the device inside a sleeve over the cheek that wraps around the head with feedback from dentists and patients for easier and better use compliance, efficacy, FDA indication and reimbursement
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
nCAP Medical has developed an effective, safe, opioid-sparing, non-pharmacological analgesic device, NeuroCuple®, that can reduce opioid use and surgical pain.
The sham patch is identical to the active patch but with no active agents.
University of Pittsburgh School of Dental Medicine
Pittsburgh, Pennsylvania, United States
Opioid Consumption
Total prescription opioid use in Oral Morphine Milligram Equivalent (MME) in first 48 hours
Time frame: First 48 hours post extraction
Opioid Consumption
Total prescription opioid use in Oral Morphine Milligram Equivalent (MME) on post-operative day 7
Time frame: post-extraction Day 7
Opioid Consumption
Total prescription opioid use in Oral Morphine Milligram Equivalent (MME) on post-extraction day 30
Time frame: post-extraction Day 30
Opioid Consumption
Total prescription opioid use in Oral Morphine Milligram Equivalent (MME) on post-extraction day 90
Time frame: post-extraction Day 90
Post-Operative Pain Score
Average pain score based on Brief Pain Inventory (BPI)- Severity (0=no pain and 10=worst imaginable pain) in first 48 hours post extraction.
Time frame: 48 hours post-extraction
Opioid prescription refills
Opioid prescription refills via Prescription Drug Monitoring Program (PDMP) at 1 week post extraction
Time frame: One week post extraction
Opioid prescription refills
Opioid prescription refills via Prescription Drug Monitoring Program (PDMP) at 30 days post extraction
Time frame: post-extraction day 30
Opioid prescription refills
Opioid prescription refills via Prescription Drug Monitoring Program (PDMP) at 90 days post extraction
Time frame: post-extraction day 90
Pain Interference
Measured by BPI on post-extraction days 1-7, 30 days and 90 days
Time frame: post-extraction days 1-7, 30 days and 90 days
Daily use of non-opioid analgesics
measured in MME
Time frame: post-extraction days 1-7
Time to normalcy (work or activity, and solid food intake)
measured in hours
Time frame: post-extraction days 1-7
Adverse events (i.e., ER visit, hospitalization, opioid side-effects, intervention side effects)
monitored via EMR and ePRO
Time frame: post-extraction days 1-7
Sleep quality
Pittsburgh Sleep Questionnaire 3 (PSQ3, range 0-21)
Time frame: post-extraction days 1-7
Risk of opioid misuse and abuse using Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R)
score greater than or equal to 18 is positive for being at risk for developing OUD
Time frame: post-extraction day 7, 1 month, and 3 months.
Protocol adherence in first 48 hours
yes/no if they kept the patch on per the protocol
Time frame: 48 hours post-extraction
patient satisfaction
0-5 score with greater score greater satisfaction
Time frame: 48 hours post-extraction
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