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

January 6, 2026 updated by: Lauren H. Redler, Columbia University

Clinical Evaluation of an External Neuromodulation Device (VibraCool) to Reduce Pain and Opioid Use After Anterior Cruciate Ligament Reconstruction (ACLR)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard Ice packs
Standard ice packs applied to knee for 20 minutes a day three times a day
Device: Standard ice packs
Cold also provides peripheral gate-control relief via small, slow C-Fibers that transmit low level pain. In addition to local pain relief, intense cold can raise the A pain threshold distant to the location. The mechanism has been called descending or diffuse noxious inhibitory relief, or more recently conditioned pain modulation (CPM). Injections, aches, and infiltration of local anesthesia and dermal fillers are relieved by applying cold. For acute injury, near freezing cold relieves pain by suppressing the local metabolic production of inflammation and concomitant tissue ischemia from hypoxia due to the increased metabolic rate.
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
Device: VibraCool mechanical stimulation and neuromodulatory therapeutic device
Multiple studies have shown that vibration sources applied to muscles prior to exercise reduced soreness and lactate dehydrogenase production, and increased range of motion at 48 and 72 hours. Acute pain results from fast A nerves transmitting nociceptive information to the dorsal column, where the substantia gelatinosa's interneurons prioritize competing A mechanoreceptor and C-fibers to slow pain transmission. One study observed that stimulation of A mechanoreceptors "shut the gate" on pain transmission, an inhibitory mechanism known as "gate control". Multiple physical methodologies leverage gate control physiology for pain relief, such as vibratory massage therapy and electrical stimulation to varying degrees. However, the use of vibratory massage to improve pain control and reduce opioid use following ACLR has not been well studied, and to our knowledge there are no randomized control trials (RCTs) evaluating the use of this modality compared to standard ice or cryocompression.
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
Device: Cryocompression (Game Ready, Bregs) device
Cryotherapy has also been used as an adjunctive post-operative therapy to reduce pain and inflammation following anterior cruciate ligament reconstruction (ACLR). It has been shown to decrease local metabolism, resulting in reduced pain and inflammation. Multiple studies have shown the benefits of using cryotherapy after ACLR, and more recently dynamic intermittent compression has been shown to improve circulation while reducing the risk of skin necrosis associated with static permanent compression. A recent meta-analysis including ten RCTs found significant reductions in post-operative VAS pain scores and breakthrough opioid consumption when using cryotherapy, such as Game Ready or Breggs ice therapy, following ACLR.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Opioid use
Time Frame: 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
First 3 post-operative days
Visual Analog Score (VAS) for pain
Time Frame: 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
First 7 post-operative days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean reduction in opioid use in mg of morphine equivalents per day
Time Frame: 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
First 7 post-operative days
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference score
Time Frame: 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.
First 7 post-operative days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAAU3696

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

None will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings