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

30 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Cryoneurolysis for low back pain?

Research shows that cryoneurolysis has been reported to induce favorable outcomes in lumbar facet joint pain, which is a common cause of low back pain. Clinical studies have reported promising results, focusing on improvements in pain scores and patient satisfaction. ^{1 2 3 4 5}

How does cryoneurolysis differ from other treatments for low back pain?

Cryoneurolysis is unique because it uses extreme cold to temporarily disable nerves that cause pain, offering an alternative to traditional methods like radiofrequency ablation, which uses heat. This approach can be effective for chronic pain conditions and may provide temporary relief, allowing for repeated treatments if successful. ^{2 3 6 7 8}

What is the purpose of this trial?

Low back pain (LBP) is the leading cause of disability worldwide. Currently available treatment options for treating low back facet joint pain include acupuncture, pain medications, psychotherapy, anti-inflammatory steroid injections into the joints, exercise, physical therapy, rest, chiropractic treatments, surgery, and radiofrequency ablation (RFA). RFA uses radio waves to target and burn the nerves that send the pain signals to the participant's brain. The purpose of this study is to compare the standard treatment of RFA to a newer therapy called iovera°. The iovera° system is a newer procedure for nerve pain that freezes the targeted nerves leading to a temporary block of the nerve without causing any permanent damage to the nerve. With the nerve blocked, pain is immediately relieved. The nerve reconnects over time and goes back to working exactly as it did before the procedure. The investigators want to see if iovera° therapy is effective in treating people with facet joint-mediated chronic low back pain (CLBP). If the participant decide to participate in the study, the investigators will ask the participant to undergo either an RFA or iovera° procedure to treat the participant's CLBP. After the procedure, the investigators will ask the participant to complete surveys to track the participant's response to the procedure at 15 time points over a 1-year period. These time points consist of phone calls and online surveys.

Research Team

Neil A Segal, MS, MD

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

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.

Subjects with a history of drug abuse

I have had RFA treatment on my back.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

References

1. Austria pubmed.ncbi.nlm.nih.gov

Cryoneurolysis for zygapophyseal joint pain: a retrospective analysis of 117 interventions. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

An in vitro analysis of the size and shape of cryolesions for facet joint denervation. [2017]

3. England pubmed.ncbi.nlm.nih.gov

Cryoneurolysis' outcome on pain experience (COPE) in patients with low-back pain: study protocol for a single-blinded randomized controlled trial. [2021]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Cryoneurolysis for the treatment of cervical facet joint syndrome: a technical note. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Cooled radiofrequency ablation versus cryoneurolysis of the genicular nerves for the symptomatic pain management in knee osteoarthritis: a study protocol of a prospective, randomized, single-blinded clinical trial. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Radiofrequency denervation and cryoablation of the lumbar zygapophysial joints in the treatment of positive lumbar facet joint syndrome - a report of three cases. [2022]

7. India pubmed.ncbi.nlm.nih.gov

Efficacy of cryoneurolysis in the management of chronic non-cancer pain: A systematic review and meta-analysis. [2022]

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

Cryoneurolysis of Innervation to Sacroiliac Joints: Technical Description and Initial Results-A Case Series. [2021]