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

Columbia University

Status: Enrolling

Conditions: ACL; Vibration; Exposure; Pain, Postoperative; Cryotherapy Effect; Opioid Use

Treatments: Device: Standard ice packs; Device: VibraCool mechanical stimulation and neuromodulatory therapeutic device; Device: Cryocompression (Game Ready, Bregs) device

Study type: Interventional

Funder types: Other

Identifiers

NCT06456268

AAAU3696

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 3 patient groups

Standard Ice packs

Active Comparator group

Description:

Standard ice packs applied to knee for 20 minutes a day three times a day

Treatment:

Device: Standard ice packs

Cryocompression device

Active Comparator group

Description:

Cryocompression device (Game Ready, Bregs) with ice placed into the device and applied to knee for 20 minutes a day, three times a day

Treatment:

Device: Cryocompression (Game Ready, Bregs) device

VibraCool

Experimental group

Description:

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

Treatment:

Device: VibraCool mechanical stimulation and neuromodulatory therapeutic device