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

Not Applicable

Recruiting

• Conditions: ACL; Vibration; Exposure; Opioid Use; Cryotherapy Effect; Pain, Postoperative
• Interventions: Device: VibraCool mechanical stimulation and neuromodulatory therapeutic device; Device: Standard ice packs; Device: Cryocompression (Game Ready, Bregs) device

• Registration Number: NCT06456268
• Lead Sponsor: Columbia University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-08
• Study First Submitted QC: 2024-06-08
• Study First Posted: 2024-06-13
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-03
• Study Start: 2025-05-30
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Underwent ACL reconstruction

Exclusion Criteria

• Pediatric iliotibial band ACL reconstruction (known to cause significantly more pain)
• Non-english speakers (limitations of our study group)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VibraCool	VibraCool mechanical stimulation and neuromodulatory therapeutic device	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
Standard Ice packs	Standard ice packs	Standard ice packs applied to knee for 20 minutes a day three times a day
Cryocompression device	Cryocompression (Game Ready, Bregs) 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

Primary Outcome Measures

Name	Time	Method
Visual Analog Score (VAS) for pain	First 7 post-operative days	Scale of 0 to 10, with 10 being the worst pain and 0 being no pain. Will record daily mean VAS pain scores over the first seven post-operative days
Opioid use	First 3 post-operative days	Percent of patients discontinuing opioid use by or on post-operative day three, compared to those who continue after day three

Secondary Outcome Measures

Name	Time	Method
Mean reduction in opioid use in mg of morphine equivalents per day	First 7 post-operative days	mean reduction in opioid use in milligrams of morphine equivalents per day (MMOD) of 30% from patients not using the device over the 7-day period
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference score	First 7 post-operative days	PROMIS is a computerized adaptive patient-reported test to measure interference of pain in everyday functioning. The raw score is converted to a T-score metric in which 50 is the mean and 10 is the standard deviation. Higher T-scores represent increased pain interference.

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States