Using NEUROCUPLE™ patch for pain management after knee surgery
Enhancing Pain Management for Knee Replacement Patients Through an Innovative Non-invasive and Opioid-sparing Device (NEUROCUPLE™)
This study is testing if the NEUROCUPLE™ patch can help reduce pain and the need for opioids in people recovering from knee surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | nCap Medical Industry-sponsored |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT06460350 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the NEUROCUPLE™ patch in reducing pain and opioid consumption in patients undergoing total knee arthroplasty (TKA). It is a randomized, placebo-controlled study where participants will receive either the active patch or a placebo patch for 30 days post-surgery. The goal is to establish NEUROCUPLE™ as a non-opioid pain management solution, potentially improving recovery outcomes and reducing reliance on opioids. The study aims to address the significant postoperative pain that affects many TKA patients and contributes to long-term opioid use.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 scheduled for elective primary unilateral TKA with low anxiety levels.
Not a fit: Patients with severe chronic pain conditions requiring daily opioid use or those undergoing bilateral TKA may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative pain and opioid consumption for TKA patients.
How similar studies have performed: Other studies have explored non-opioid pain management strategies, but the specific use of NEUROCUPLE™ is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \>18 years of age * Scheduled for elective primary unilateral TKA * T-score \< 60 on the PROMIS Anxiety measure Exclusion Criteria: * Children (\<18 yr.) * 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) * Severe chronic pain condition that requires daily preoperative opioid dependence * T-score ≥ 60 in any of the three PROMIS measures (i.e., sleep, anxiety, and depression) * Other concomitant surgery being performed in addition to TKA * Patients undergoing bilateral TKA * Patients undergoing knee replacement revision * Patients with limited mobility (in a wheelchair or requiring a walker) * Patients who are not returning home after surgery
Where this trial is running
Pittsburgh, Pennsylvania
- UPMC Shadyside Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Jacques E. Chelly, MD, PhD, MBA — University of Pittsburgh / UPMC
- Study coordinator: Anthony Sutera
- Email: tsutera@ncap.com
- Phone: 801-566-4124
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.