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)

Overview

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

• 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 tr
• 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 compress
• 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 s

Primary outcome measures

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

Secondary outcome measures (2)

• Mean reduction in opioid use in mg of morphine equivalents per day [Time frame: First 7 post-operative days]
• Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference score [Time frame: First 7 post-operative days]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Columbia University Medical Center — New York

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT06456268 · AAAU3696

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗