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

Trial Summary

What is the purpose of this trial?

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.

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.

How does the VibraCool Device treatment differ from other treatments for pain after ACL surgery?

The VibraCool Device is unique because it combines vibration and cold therapy to relieve pain, unlike other treatments that may rely on medications or static cryotherapy. This approach can help reduce pain without the need for opioids, which are commonly used but have a risk of addiction. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

References

1. Spain pubmed.ncbi.nlm.nih.gov

Home-based intravenous analgesia with elastomeric pump as an outpatient procedure for pain control after anterior cruciate ligament repair. [2021]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Comparison of a Cryopneumatic Compression Device and Ice Packs for Cryotherapy Following Anterior Cruciate Ligament Reconstruction. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Editorial Commentary: Postoperative Pain Management After Anterior Cruciate Ligament Reconstruction Can Minimize Opioid Use and Allow Early Rehabilitation. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Pain Management Strategies After Anterior Cruciate Ligament Reconstruction: A Systematic Review With Network Meta-analysis. [2021]

5. France pubmed.ncbi.nlm.nih.gov

Cryotherapy with dynamic intermittent compression for analgesia after anterior cruciate ligament reconstruction. Preliminary study. [2022]