Cryoneurolysis for Knee Pain

Overseen By Luana Melo

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Unity Health Toronto

Must not be taking: Opioids

Disqualifiers: Pregnancy, Cryoglobulinemia, Raynaud's, others

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to manage knee pain for individuals undergoing knee replacement. It tests a device called Iovera, which uses extreme cold to freeze nerves and reduce pain, potentially easing recovery and reducing the need for pain medication like opioids. Participants will receive either this cold therapy (cryoneurolysis) or a placebo before surgery to determine which is more effective. Suitable candidates are those with severe knee arthritis requiring a knee replacement who have not received certain knee injections in the past six months. As an unphased trial, this study allows participants to contribute to innovative pain management research that could enhance recovery experiences.

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

The trial requires that you are not currently using opioids. If you are taking opioids, you would need to stop before participating.

What prior data suggests that the Iovera cryoneurolysis device is safe for knee pain treatment?

Research shows that cryoneurolysis, using the Iovera device, is generally well-tolerated. Studies have found that this treatment significantly reduces pain and improves the quality of life for those with knee osteoarthritis. It can provide pain relief for up to 90 days, which is promising for individuals preparing for knee replacement surgery.

In terms of safety, this treatment is already available in Canada, indicating it meets certain safety standards. Clinical settings have reported no major side effects. Patients generally handle the procedure well, with the most common side effects being temporary and mild, such as numbness or bruising at the treatment site. Overall, evidence suggests that cryoneurolysis with Iovera is a safe option for managing knee pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about cryoneurolysis for knee pain because it offers a unique approach compared to standard treatments like pain medications, physical therapy, and corticosteroid injections. Unlike these typical options, cryoneurolysis involves using the Iovera device to deliver freezing cold therapy directly to the nerves in the knee, effectively numbing pain by disrupting nerve signals. This method is non-invasive and can provide rapid pain relief without the need for systemic drugs, which often come with side effects. By targeting the nerves with precision, this treatment has the potential to offer longer-lasting relief for knee pain sufferers.

What evidence suggests that the Iovera cryoneurolysis device is effective for reducing knee pain?

Research shows that cryoneurolysis, using devices like the Iovera, can greatly reduce knee pain. In this trial, some participants will receive the Iovera treatment, which studies have found can lower pain levels by up to 56% in people with knee osteoarthritis. This pain relief can last for up to 90 days. Additionally, cryoneurolysis improves movement and enhances quality of life. Early results also suggest it can lead to less pain and better function for up to six months after treatment. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

Both male and female patients can participate.

You have not received an injection in one of your knees with steroids or biologics in the last 6 months.

You are able to read and understand English and give permission to participate in the study with full knowledge of what it entails.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Treatment

Participants receive cryoneurolysis treatment using the Iovera device or placebo prior to surgery

1 day

1 visit (in-person)

Postoperative Follow-up

Participants are monitored for pain management, function, and opioid consumption

12 weeks

Multiple visits (in-person and virtual) at 2, 6, and 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Iovera - Cryoneurolysis
• Local anesthetic

How Is the Trial Designed?

Group I: Iovera Experimental Treatment 1 Intervention

Cryoneurolysis + standard of care: Usual intervention plus pre-operation Iovera treatment. Patients will receive local anaesthesia unilaterally to the affected knee prior to the treatment and then the anesthesiologist will administer the freezing cold therapy (Iovera device) to the affected knee.

Group II: Placebo Placebo Group 1 Intervention

Placebo: Usual intervention plus pre-operation placebo. The placebo group will receive short-acting local anaesthesia injection unilaterally to the affected knee.

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials

572

Recruited

470,000+

Citations

1. iovera.com iovera.com/results-with-iovera

iovera Clinical Results | Pain Relief Outcomes See proven cryoneurolysis results with iovera. Clinical data for knee, hip, shoulder, spine, rib & post-surgical pain management.

2. ioverapro.com ioverapro.com/oa-clinical-efficacy-data

OA Clinical Data | iovera Efficacy Studies for HCPs In patients with OA knee pain. Reduced Pain and Improved Movement up to 90 Days1. Up to 56% reduction in WOMAC pain scores from baseline1. Clinical data ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12061374/

Efficacy of Cryoneurolysis on Chronic Pain in Patients with ... After 6 months, the cryoneurolysis group showed a significant reduction in 24-h numeric rating scale pain scores compared to sham (1.1; 95% CI, 0.3 to 1.9; P = ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0976566225001547

Outcome of cryoneurolysis treatment in knee osteoarthritis Findings revealed that cryoneurolysis significantly improved pain relief, functional outcomes (measured by WOMAC and KOOS), and quality of life, with effects ...

5. arthroplastyjournal.org arthroplastyjournal.org/article/S0883-5403(24)00653-3/abstract

Cryoneurolysis Associated With Improved Pain, Function ... Patients receiving cryoneurolysis experienced significantly lower pain severity and SD over the 6-month follow-up than control patients (P = .

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40503005/

Outcome of cryoneurolysis treatment in knee osteoarthritis Findings revealed that cryoneurolysis significantly improved pain relief, functional outcomes (measured by WOMAC and KOOS), and quality of life, ...

7. ioverapro.com ioverapro.com/tka-clinical-efficacy-data

TKA Clinical Data | iovera Pre-Surgery Results The iovera° group demonstrated significant reductions in PROMIS pain intensity and pain interference at 2- and 6-week follow-up, respectively.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05286996

NCT05286996 | Cryoneurolysis for TKA - a Pilot Study Cryoneurolysis can relieve pain and symptoms associated with osteoarthritis of the knee for up to 90 days. Detailed Description. Patients undergoing total knee ...