Clinical Evidence & Research
What the published studies show — and what they don't.
The NeuroCuple® technology has been evaluated in two peer-reviewed randomized clinical trials at the University of Pittsburgh Medical Center, including a placebo-controlled, blinded trial funded through a National Institutes of Health award. This page presents both studies the way we believe evidence should be presented: full citations, real numbers, and the limitations alongside the findings.
The Evidence at a Glance
2023 · Randomized Pilot Study
69 patients after knee or hip replacement. Patients using the device reported significantly less pain at rest, and 52% fewer requested an opioid refill after discharge. Open-label (no placebo arm).
2026 · Placebo-Controlled Trial
156 patients after knee replacement, randomized to an active or identical sham device, with patients, clinicians, and researchers blinded. The active-device group used 26% less opioid in the first 24 hours and left the hospital 19% sooner.
Both studies were conducted in postoperative (surgical recovery) settings. That is the setting the evidence covers; our humanitarian deployments are monitored through program reporting, not these trials.
Study 1 — Randomized Pilot Study (2023)
Chelly JE, Klatt BA, Groff Y, O'Malley M, Lin H-HS, Sadhasivam S. Role of the NeuroCuple™ Device for the Postoperative Pain Management of Patients Undergoing Unilateral Primary Total Knee and Hip Arthroplasty: A Pilot Prospective, Randomized, Open-Label Study. Journal of Clinical Medicine. 2023;12:7394. doi:10.3390/jcm12237394 · NCT05252858
Patients recovering from knee or hip replacement were randomized to standard care plus two NeuroCuple devices worn for three days, or standard care alone, and followed for 30 days.
| Outcome | Result |
|---|---|
| Pain at rest, days 1–3 | 34% lower in the device group (p = 0.018) |
| Pain at rest, days 1–30 | 41% lower in the device group (p = 0.027) |
| Patients requesting an opioid refill after discharge | 52% fewer — 26% vs. 55% of patients (p = 0.016) |
| Pain during movement, days 1–3 | 12% lower — not statistically significant (p = 0.12) |
| Total opioid consumption, days 1–3 | 9% lower — not statistically significant (p = 0.37) |
| Safety | No device-related local side effects reported |
Study 2 — Randomized, Placebo-Controlled, Blinded Trial (2026)
Klatt BA, O'Malley M, Ayazbekova A, Lin H-HS, Sadhasivam S, Chelly JE. Nanotechnology-Based Device Reduces Pain and Immediate Opioid Requirements and Facilitates Earlier Discharge From the Hospital Following Total Knee Arthroplasty: A Randomized Placebo-Controlled Trial. The Journal of Arthroplasty. 2026 (in press). doi:10.1016/j.arth.2026.04.083 · NCT06460350
The stronger design: 156 patients recovering from knee replacement were randomized to an active device or an identical-looking sham device with no nanocapacitors, worn 12 hours a day for two weeks. Patients, nurses, surgeons, and the research team were all blinded to who had which. The trial was funded by the National Institutes of Health (NIDA award R41DA059303) and run at a tertiary and a community hospital.
| Outcome | Result |
|---|---|
| Opioid use in the first 24 hours | 26% lower — 25.6 vs. 34.4 mg morphine-equivalent (p = 0.015) |
| Hospital length of stay | 19% shorter — 20.8 vs. 25.7 hours (p = 0.006) |
| Pain at rest at one week | 14% lower — 3.5 vs. 4.1 on a 0–10 scale (p = 0.04, one-sided) |
| Nausea/vomiting & rescue anti-nausea medication | 30% and 41% lower rates per patient — post-hoc endpoints that did not reach conventional statistical significance |
| Opioid refills within six weeks | Similar between groups — 38% vs. 39% (p = 0.87) |
| Functional outcomes (walking, range of motion, WOMAC) | No significant differences between groups |
| Safety | 18 mild device-related events (compression discomfort, skin irritation), all resolved; no serious device-related adverse events |
How We Read This Evidence
Taken together, the two trials support a consistent, specific claim: in postoperative settings, the device was associated with reduced pain at rest, reduced immediate opioid use, and earlier discharge, with no serious device-related adverse events — first in an open-label pilot, then replicated under placebo-controlled, blinded conditions.
Just as important is what the evidence does not yet show. The trials studied surgical recovery over 30 days in U.S. hospitals — not chronic pain, and not the low-resource community settings where we deploy. Longer-term outcomes (like opioid refills at six weeks) showed no difference. Our humanitarian deployments are therefore measured by their own program reporting — devices delivered, training completed, usage tracked — rather than borrowed clinical claims.
Funding & Transparency
The 2026 trial was supported by the National Institute on Drug Abuse of the National Institutes of Health (award R41DA059303). The device's manufacturer, nCap Medical (Heber City, UT), provided the active and sham devices used in the research, as disclosed in the publications. Both trials are registered on ClinicalTrials.gov (NCT05252858, NCT06460350), and both papers are published open access, so anyone can read the full studies — we encourage it.
Evidence Is How We Earn Trust
Every deployment we run stands on this research — presented whole, limitations included. Read how the device works, or put one to work where pharmacies don't reach.