Clinical Evaluation of VibraCool Neuromodulation Device to Reduce Pain and Opioid Use After Anterior Cruciate Ligament Reconstruction

What this Trial Is About

Researchers are evaluating the effects of the VibraCool mechanical stimulation neuromodulatory therapeutic device on reducing post-operative pain and opioid use after anterior cruciate ligament reconstruction (ACLR). The study aims to understand if this device can reduce residual opioids in circulation compared to standard treatments. This is a randomized clinical trial led by Columbia University, assessing pain and opioid use after surgery. Participants will be divided into three groups receiving different treatments applied to the knee for 20 minutes, three times a day: standard ice packs, a cryocompression device with ice, or the VibraCool device with ice. The VibraCool device uses vibration and neuromodulation to potentially reduce pain by affecting nerve signaling. The cryocompression device combines cold therapy with intermittent compression to improve circulation and reduce inflammation. During the first seven days after surgery, researchers will measure pain using the Visual Analog Score (VAS) and opioid use during the first three days. Additional assessments include opioid reduction in morphine equivalents and patient-reported pain interference scores. Participants will be monitored closely for these outcomes and safety throughout this post-operative period. The study is scheduled to start in June 2026 and end in November 2026.

VibraCool Device to Reduce Pain and Opioid Use After Anterior Cruciate Ligament Reconstruction (ACLR)