Cryoneurolysis vs Radiofrequency Ablation for Low Back Pain

Overseen By Jessica Lee, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Cancer, Back surgery, Drug abuse, others

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

Compensation: Varies

Number of Visits: 17

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two treatments for chronic low back pain: radiofrequency ablation (RFA) and cryoneurolysis (also known as iovera° therapy). RFA uses radio waves to burn the nerves causing pain, while iovera° freezes the nerves to temporarily stop pain signals without causing permanent damage. Researchers aim to determine if the newer iovera° method is as effective as the standard RFA. This trial may suit individuals who have experienced chronic low back pain for at least three months and have not found relief with other treatments like physical therapy or pain medications. As an unphased trial, it offers a unique opportunity to explore innovative treatments for chronic pain.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that cryoneurolysis, using the iovera° system, is safe. Studies have found it reduces pain without causing long-term nerve damage. Most people tolerate it well, often resulting in a reduced need for opioids after treatment.

For radiofrequency ablation (RFA), studies also indicate its safety in treating low back pain. Some patients experience complete pain relief, although the effects may diminish over time.

Both treatments have been used effectively and safely, but individual experiences can vary. It is important to discuss possible side effects with a doctor before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for low back pain because they offer unique approaches to targeting nerve pain. Cryoneurolysis uses liquid nitrous oxide to create a precise cold zone that causes Wallerian degeneration, specifically targeting the medial branch nerve without damaging surrounding tissues. On the other hand, Radiofrequency Ablation uses heat to denature the same nerve, providing pain relief by disrupting nerve signals. These methods are distinct because they focus on minimally invasive techniques that aim to provide targeted relief while preserving surrounding structures, potentially offering quicker recovery and fewer side effects compared to traditional surgical options.

What evidence suggests that this trial's treatments could be effective for low back pain?

This trial will compare Cryoneurolysis and Radiofrequency Ablation (RFA) for managing chronic low back pain. Studies have shown that RFA reduces pain in about 86% of patients, with some experiencing complete relief. This procedure uses heat to target and disable nerves that send pain signals. Cryoneurolysis, another treatment option in this trial, uses extreme cold to temporarily block nerve signals and has shown promise in reducing pain and improving daily activities for up to a year. Research indicates that Cryoneurolysis can lessen pain with less need for opioids while maintaining muscle movement. Both treatments offer different ways to manage chronic low back pain by focusing on the nerves that cause it. ^{1 4 5 6 7}

Who Is on the Research Team?

Neil A Segal, MS, MD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals with chronic low back pain who have not found relief through standard treatments. Participants will undergo either Radiofrequency Ablation (RFA) or the iovera° system procedure and must be willing to complete surveys over a year to track their pain levels.

Inclusion Criteria

I have had low back pain for 3 months or more.

Subjects must be able to provide informed consent, adhere to the study visit schedule, and complete all study assessments

I have tried non-surgical treatments for over three months without success.

Exclusion Criteria

I have had blood clots.

I have had RFA treatment on my back.

Subjects with a history of drug abuse

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants undergo either Radiofrequency Ablation (RFA) or iovera° procedure to treat chronic low back pain

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment through surveys and phone calls

360 days

15 time points (phone calls and online surveys)

What Are the Treatments Tested in This Trial?

Interventions

• Cryoneurolysis
• Radiofrequency Ablation

Trial Overview The study compares two procedures: RFA, which uses radio waves to burn nerves transmitting pain signals, and the iovera° system, which temporarily freezes these nerves without causing permanent damage. The effectiveness of both in treating chronic low back pain is being evaluated.

How Is the Trial Designed?

Group I: iovera system Active Control 1 Intervention

Uses liquid nitrous oxide contained within the device and a closed-end needle to create a precise zone of cold to denature the target medial branch nerve supplying the facet joint by Wallerian degeneration (second degree axonotmesis) preserving the epineurium, perineurium, and endoneurium.

Group II: Radiofrequency ablation Active Control 1 Intervention

Utilizes radiofrequency energy to heat and denature the target medial branch nerve supplying the facet joint.

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07214844

A Prospective Study to Evaluate the Efficacy of Iovera ... A research study is being conducted to compare two treatments for long-term low back pain: One uses the iovera° system, which applies cold ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11931670/

Cryoneurolysis: A Comprehensive Review of Applications in ... Cryoneurolysis, a technique that uses extreme cold to disrupt nerve conduction, has demonstrated potential in managing both acute and chronic pain.

3. rmdopen.bmj.com rmdopen.bmj.com/content/10/2/e004196

Cryoneurolysis versus radiofrequency ablation outcome on ... Only pain catastrophising at 3 months follow-up was lower in the RF denervation group compared with placebo (12.5±10.6) and higher in the ...

4. cureus.com cureus.com/articles/337006-cryoneurolysis-a-comprehensive-review-of-applications-in-pain-management

Cryoneurolysis: A Comprehensive Review of Applications ... Reduced pain with significantly less opioid usage along with less time. Additionally, the full range of motor function was observed two to three ...

5. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-021-04320-7

Cryoneurolysis' outcome on pain experience (COPE) in ... One prospective trial found a significant reduction in pain intensity and improvement in daily activities at all follow-up times up to one year ...

6. 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.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8135178/

study protocol for a single-blinded randomized controlled trial A review from 2007 found the level of evidence for the efficacy of radiofrequency or cryoneurolysis to be moderate for short and long-term pain ...