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

NCT06456268 | Recruiting DMC FDA Device

• 1 other identifier: AAAU3696
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (2)

• Visual Analog Score (VAS) for pain

  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

• Opioid use

  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

Secondary Outcomes (2)

• Mean reduction in opioid use in mg of morphine equivalents per day

  First 7 post-operative days

• Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference score

  First 7 post-operative days

Study Arms (3)

Standard Ice packs

ACTIVE COMPARATOR

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

Device: Standard ice packs

Cryocompression device

ACTIVE COMPARATOR

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

VibraCool

EXPERIMENTAL

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

Interventions

VibraCool mechanical stimulation and neuromodulatory therapeutic device 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.

VibraCool

Cryocompression (Game Ready, Bregs) device 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.

Cryocompression device

Standard ice packs DEVICE

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.

Standard Ice packs

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Underwent ACL reconstruction

You may not qualify if:

• Pediatric iliotibial band ACL reconstruction (known to cause significantly more pain)
• Non-english speakers (limitations of our study group)

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

Related Publications (10)

• Bartels K, Mayes LM, Dingmann C, Bullard KJ, Hopfer CJ, Binswanger IA. Opioid Use and Storage Patterns by Patients after Hospital Discharge following Surgery. PLoS One. 2016 Jan 29;11(1):e0147972. doi: 10.1371/journal.pone.0147972. eCollection 2016.

  PMID: 26824844 BACKGROUND

• Webster BS, Verma SK, Gatchel RJ. Relationship between early opioid prescribing for acute occupational low back pain and disability duration, medical costs, subsequent surgery and late opioid use. Spine (Phila Pa 1976). 2007 Sep 1;32(19):2127-32. doi: 10.1097/BRS.0b013e318145a731.

  PMID: 17762815 BACKGROUND

• Bleakley C, McDonough S, MacAuley D. The use of ice in the treatment of acute soft-tissue injury: a systematic review of randomized controlled trials. Am J Sports Med. 2004 Jan-Feb;32(1):251-61. doi: 10.1177/0363546503260757.

  PMID: 14754753 BACKGROUND

• Clarke H, Soneji N, Ko DT, Yun L, Wijeysundera DN. Rates and risk factors for prolonged opioid use after major surgery: population based cohort study. BMJ. 2014 Feb 11;348:g1251. doi: 10.1136/bmj.g1251.

  PMID: 24519537 BACKGROUND

• Crystal NJ, Townson DH, Cook SB, LaRoche DP. Effect of cryotherapy on muscle recovery and inflammation following a bout of damaging exercise. Eur J Appl Physiol. 2013 Oct;113(10):2577-86. doi: 10.1007/s00421-013-2693-9. Epub 2013 Jul 20.

  PMID: 23873339 BACKGROUND

• Davey MS, Hurley ET, Anil U, Moses A, Thompson K, Alaia M, Strauss EJ, Campbell KA. Pain Management Strategies After Anterior Cruciate Ligament Reconstruction: A Systematic Review With Network Meta-analysis. Arthroscopy. 2021 Apr;37(4):1290-1300.e6. doi: 10.1016/j.arthro.2021.01.023. Epub 2021 Jan 28.

  PMID: 33515736 BACKGROUND

• Scully RE, Schoenfeld AJ, Jiang W, Lipsitz S, Chaudhary MA, Learn PA, Koehlmoos T, Haider AH, Nguyen LL. Defining Optimal Length of Opioid Pain Medication Prescription After Common Surgical Procedures. JAMA Surg. 2018 Jan 1;153(1):37-43. doi: 10.1001/jamasurg.2017.3132.

  PMID: 28973092 BACKGROUND

• Hollins M, Roy EA, Crane SA. Vibratory antinociception: effects of vibration amplitude and frequency. J Pain. 2003 Sep;4(7):381-91. doi: 10.1016/s1526-5900(03)00714-4.

  PMID: 14622680 BACKGROUND

• Khanna A, Gougoulias N, Maffulli N. Intermittent pneumatic compression in fracture and soft-tissue injuries healing. Br Med Bull. 2008;88(1):147-56. doi: 10.1093/bmb/ldn024. Epub 2008 Jul 1.

  PMID: 18596049 BACKGROUND

• Benedetti MG, Boccia G, Cavazzuti L, Magnani E, Mariani E, Rainoldi A, Casale R. Localized muscle vibration reverses quadriceps muscle hypotrophy and improves physical function: a clinical and electrophysiological study. Int J Rehabil Res. 2017 Dec;40(4):339-346. doi: 10.1097/MRR.0000000000000242.

  PMID: 28723717 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded data will be provided to the statistician w/o reference to specific treatment arms
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthopedic Surgery

Study Record Dates

• First Submitted: June 8, 2024
• First Posted: June 13, 2024
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)