Clinical Evaluation of an External Neuromodulation Device (VibraCool) to Reduce Pain and Opioid Use After Anterior Cruciate Ligament Reconstruction (ACLR)
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The goal of this project is to test the effects of the VibraCool mechanical stimulation neuromodulatory therapeutic device on post-operative pain and opioid use following anterior crucitate ligament reconstruction (ACLR), and thus residual opioids in circulation.
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: t
View:
• Underwent ACL reconstruction
Locations
United States
New York
Columbia University Medical Center
RECRUITING
New York
Time Frame
Start Date: 2025-09-30
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 130
Treatments
Active_comparator: Standard Ice packs
Standard ice packs applied to knee for 20 minutes a day three times a day
Active_comparator: Cryocompression device
Cryocompression device (Game Ready, Bregs) with ice placed into the device and applied to knee for 20 minutes a day, three times a day
Experimental: VibraCool
FDA-approved VibraCool mechanical stimulation and neuromodulatory therapeutic device with ice placed into it and applied to knee for 20 minutes a day, three times a day
Related Therapeutic Areas
Sponsors
Leads: Columbia University