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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06456268
Enrollment
130
Registered
2024-06-13
Start date
2026-06-30
Completion date
2026-11-30
Last updated
2026-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICEVibraCool 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.

DEVICECryocompression (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.

DEVICEStandard 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.

Sponsors

Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Blinded data will be provided to the statistician w/o reference to specific treatment arms

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog Score (VAS) for painFirst 7 post-operative daysScale 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 useFirst 3 post-operative daysPercent of patients discontinuing opioid use by or on post-operative day three, compared to those who continue after day three

Secondary

MeasureTime frameDescription
Mean reduction in opioid use in mg of morphine equivalents per dayFirst 7 post-operative daysmean 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 scoreFirst 7 post-operative daysPROMIS 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026