VibraCool Device for Pain After ACL Surgery

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Pediatric ACL reconstruction, Non-english speakers

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the VibraCool device can reduce pain and lower opioid use after ACL surgery. Participants will apply the VibraCool, which provides mechanical stimulation and cold therapy, to their knee. The trial will compare VibraCool's effects with standard ice packs and a cryocompression device. Individuals who have undergone ACL reconstruction, excluding a specific type known to cause more pain, may be suitable for this study. The goal is to discover better methods for managing post-surgery pain and reducing opioid reliance. As an unphased trial, this study allows participants to contribute to innovative pain management solutions.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the VibraCool device is safe for post-operative pain management?

Research has shown that the VibraCool device is generally safe for use. In one study, fewer than 3% of users reported side effects, and only 8.7% required additional pain medication. This suggests the device is safe for most people and may help reduce the need for strong painkillers like opioids. The FDA has already approved the device for other uses, enhancing its safety credibility. Overall, evidence suggests that the VibraCool device is a safe option for managing pain after ACL surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the VibraCool device for pain relief after ACL surgery because it combines mechanical stimulation with cold therapy, which is unique compared to traditional methods. While standard treatments like ice packs and cryocompression devices primarily rely on cold to reduce swelling and numb pain, the VibraCool adds vibration to help block pain signals and enhance circulation. This dual-action approach could potentially offer faster and more effective pain relief, making recovery quicker and more comfortable for patients.

What evidence suggests that the VibraCool device is effective for reducing pain after ACL surgery?

Research has shown that the VibraCool device, which participants in this trial may receive, can greatly reduce pain. One study found that people experienced a 57% drop in pain on a 10-point scale. The device also reduces the need for opioids, which is especially beneficial after surgeries like ACL reconstruction. VibraCool reportedly manages pain four times more effectively than other methods. Overall, it has proven effective in relieving pain, regardless of the patient's age or the duration of their pain. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals who have undergone ACL reconstruction surgery. It's not suitable for those who had pediatric IT band ACL reconstruction or non-English speakers due to the specific needs of the study.

Inclusion Criteria

I have had ACL reconstruction surgery.

Exclusion Criteria

I am a child undergoing IT band ACL reconstruction, known for high pain levels.

Non-English speakers (limitations of our study group)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants use the VibraCool device or comparator devices for post-operative pain management

1 week

Daily use at home

Follow-up

Participants are monitored for pain levels and opioid use reduction

1 week

What Are the Treatments Tested in This Trial?

Interventions

• VibraCool Device

Trial Overview

The study tests pain management after ACL surgery using three methods: a Game Ready cryotherapy device, standard ice packs, and a VibraCool device that combines cold therapy with vibration.

How Is the Trial Designed?

Group I: VibraCool Experimental Treatment 1 Intervention

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

Group II: Cryocompression device Active Control 1 Intervention

Cryocompression device (Game Ready, Bregs) with ice placed into the device and applied to knee for 20 minutes a day, three times a day

Group III: Standard Ice packs Active Control 1 Intervention

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

VibraCool Device is already approved in United States for the following indications:

Approved in United States as VibraCool for:

• Temporary relief of minor injuries (muscle or tendon aches)
• Treatment of myofascial pain post-surgery
• Use prior to or during physical therapy to treat myofascial pain caused by trigger points, restricted motion and muscle tension

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Published Research Related to This Trial

Nerve blocks are highly effective for managing postoperative pain after anterior cruciate ligament reconstruction (ACLR), significantly reducing pain and opioid use, although no specific nerve block was found to be superior to others in the analysis of 74 randomized controlled trials.

Intra-articular injections of bupivacaine combined with an adjunct can effectively lower postoperative pain scores for up to 12 hours after ACLR, also leading to reduced opioid consumption, highlighting their role in pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain Management Strategies After Anterior Cruciate Ligament Reconstruction: A Systematic Review With Network Meta-analysis. Davey, MS., Hurley, ET., Anil, U., et al.[2021]

In a study of 56 patients who underwent ACL reconstruction, the use of a cryopneumatic compression device significantly reduced pain levels on postoperative day 4 compared to standard ice packs, as measured by a visual analog scale (VAS).

The cryopneumatic compression group also experienced significantly less joint effusion post-surgery, indicating better management of swelling compared to the ice pack group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of a Cryopneumatic Compression Device and Ice Packs for Cryotherapy Following Anterior Cruciate Ligament Reconstruction. Yang, JH., Hwang, KT., Lee, MK., et al.[2023]

In a study of 39 patients who underwent ACL reconstruction, dynamic intermittent compression combined with cryotherapy significantly reduced the need for analgesic drugs compared to static compression, with a notable decrease in tramadol and morphine usage.

Patients receiving dynamic compression also achieved better knee flexion at discharge, with an average of 90.5° compared to 84.5° for those with static compression, indicating improved postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryotherapy with dynamic intermittent compression for analgesia after anterior cruciate ligament reconstruction. Preliminary study. Murgier, J., Cassard, X.[2022]

Effective pain management after ACL reconstruction can significantly reduce opioid use, which is crucial given the high rates of opioid prescriptions in orthopedic surgery and the risk of postoperative abuse.

Combined femoral-sciatic nerve blocks are highlighted as a top analgesic technique, while adductor canal nerve blocks offer a safer alternative with less risk of affecting muscle strength, making them preferable for minimizing complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial Commentary: Postoperative Pain Management After Anterior Cruciate Ligament Reconstruction Can Minimize Opioid Use and Allow Early Rehabilitation. Hurley, ET., Danilkowicz, RM., Toth, AP.[2023]

In a study of 309 patients undergoing anterior cruciate ligament repair, the use of an elastomeric pump for postoperative pain management resulted in mild pain for 44.7% of patients and 38.5% reporting no pain at all during the immediate recovery period.

The elastomeric pump was associated with low rates of adverse effects (fewer than 3%) and minimal need for additional analgesic medication (8.7%), indicating it is a safe and effective method for managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based intravenous analgesia with elastomeric pump as an outpatient procedure for pain control after anterior cruciate ligament repair. Villalba, J., Peñalver, J., Torner, P., et al.[2021]

Citations

1.

paincarelabs.com

paincarelabs.com/hubfs/00.%20Documents/Literature%20Reviews/00.%20VibraCool%20Literature%20Review%20-%202020.pdf?hsLang=en

VibraCool® 2024 Literature Review

“Results suggested pain relief independent of thermal modality, patient age, or pain chronicity.” Pain reduced 57% on 10-pt VAS scale. DOI:10.3389/fpain.

2.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/68/NCT06456268/Prot_SAP_000.pdf

Clinical Evaluation of an External Neuromodulation Device ...

A more insightful measure may be Pain Interference (PI), known as “pain impact,” which has been shown to be a more insightful measure into how pain interferes ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6843143/

Rehabilitation Program Combined with Local Vibroacoustics ...

This study confirmed that the LBV built-in vibroacoustic sound on an ACL reconstruction could improve patients' psychological condition ...

4.

withpower.com

withpower.com/trial/phase-acl-5-2024-49280

VibraCool Device for Pain After ACL Surgery

In a study of 56 patients who underwent ACL reconstruction, the use of a cryopneumatic compression device significantly reduced pain levels on postoperative day ...

5.

gsmedtech.com

gsmedtech.com/GS/NewsDetails/Studies-prove-VibraCool-reduces-opioid-use-and-is-4X-more-effective-for-pain-than-other-technologies

Studies prove VibraCool reduces opioid use and is 4X ...

Studies prove VibraCool reduces opioid use and is 4X more effective for pain than other technologies. Pain Care Labs, the industry leader in noninvasive pain ...

6.

explore.paincarelabs.com

explore.paincarelabs.com/vibracool

VibraCool.com

VibraCool treats pain from muscle tension and muscle restriction. Treat or "pre-hab" 20 minutes 2 - 3 times a day. Pacemaker safe - HSA/FSA eligible.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8883423/

Effects of Whole-Body Vibration Therapy on Quadriceps ...

Quadriceps dysfunction is common for patients after anterior cruciate ligament reconstruction (ACLR). Whole-body vibration (WBV) could effectively treat ...