Recruiting

VibraCool Device

Sponsor:

Columbia University

Code:

NCT06456268

Conditions

ACL

Opioid Use

Cryotherapy Effect

Vibration; Exposure

Pain, Postoperative

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

VibraCool mechanical stimulation and neuromodulatory therapeutic device

Cryocompression (Game Ready, Bregs) device

Standard ice packs

Study Details

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.

Conditions

ACL

Opioid Use

Cryotherapy Effect

Vibration; Exposure

Pain, Postoperative

Study ID

NCT06456268

Start date

Jun, 2026

Status verified date

Jan, 2026

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard Ice packs

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

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

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

Interventions

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.

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.

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.

Primary outcome measure

  • Visual Analog Score (VAS) for pain [ Time Frame: First 7 post-operative days ]
  • Opioid use [ Time Frame: First 3 post-operative days ]

Central Contacts and Locations

Locations

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

More Information

Sponsor

Columbia University

Last update posted

Jan 7, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-01-07. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.