Clinical trial NCT06456268: VibraCool Device to Reduce Pain and Opioid Use After Anterior Cruciate Ligament Reconstruction (ACLR)
Official title: Clinical Evaluation of an External Neuromodulation Device (VibraCool) to Reduce Pain and Opioid Use After Anterior Cruciate Ligament Reconstruction (ACLR)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ACL
Opioid Use
Cryotherapy Effect
Vibration; Exposure
Pain, Postoperative
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 130
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Visual Analog Score (VAS) for pain
timeFrame: First 7 post-operative days
measure: Opioid use
timeFrame: First 3 post-operative days
Secondary outcomes:
measure: Mean reduction in opioid use in mg of morphine equivalents per day
timeFrame: First 7 post-operative days
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference score
timeFrame: First 7 post-operative days
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
References:
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