Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Chronic Low Back Pain

NCT06804551 | Enrolling By Invitation FDA Device

• 1 other identifier: STUDY00160986
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Low-back Pain

Keywords

iovera; radiofrequency ablation; medial branch block; chronic low back pain; cryoneurolysis

Outcome Measures

Primary Outcomes (1)

• Confirm the feasibility of a double-blinded protocol

  At the end of the study, all of the study team members will fill out a structured questionnaire to determine the feasibility. This questionnaire will include the following: 1. Considering you role in this study, is it feasible to continue to an efficacy Randomized Control Trial applying the same protocols and procedures used in the current pilot study without modifications? 2. If not, considering you role in this study, is it feasible to continue to an efficacy Randomized Control Trial applying modifications to the protocols and procedures used in the current pilot study? As the aim of this pilot study is not to assess effectiveness or efficacy, formal hypothesis testing will not be determined.

  After the last End of Study Visit

Secondary Outcomes (12)

• Current pain intensity scores in the low back region

  Screening, pretreatment, once daily during Days 1-6, Day 7 ± 2, Day 15 ± 3 days, Day 30 ± 5, Day 60 ± 5, Day 90 ± 5, Day 120 ± 5, Day 150 ± 5, Day 180 ± 5, Day 210 ± 7, Day 240 ± 7, Day 270 ± 7, Day 300 ± 7, Day 330 ± 7, Day 360 ± 7.

• Daily pain intensity scores in the low back region

  Screening, pretreatment, once daily during Days 1-6, Day 7 ± 2, Day 15 ± 3 days, Day 30 ± 5, Day 60 ± 5, Day 90 ± 5, Day 120 ± 5, Day 150 ± 5, Day 180 ± 5, Day 210 ± 7, Day 240 ± 7, Day 270 ± 7, Day 300 ± 7, Day 330 ± 7, Day 360 ± 7.

• Concomitant medication use

  Screening, once daily during Days 1-6, Day 7 ± 2, Day 15 ± 3 days, Day 30 ± 5, Day 60 ± 5, Day 90 ± 5, Day 120 ± 5, Day 150 ± 5, Day 180 ± 5, Day 210 ± 7, Day 240 ± 7, Day 270 ± 7, Day 300 ± 7, Day 330 ± 7, Day 360 ± 7.

• Functional disability

  Screening, Day 30 ± 5, Day 60 ± 5, Day 90 ± 5, Day 120 ± 5, Day 150 ± 5, Day 180 ± 5, Day 210 ± 7, Day 240 ± 7, Day 270 ± 7, Day 300 ± 7, Day 330 ± 7, Day 360 ± 7.

• Patients' global impression of change

  Day 30 ± 5, Day 60 ± 5, Day 90 ± 5, Day 120 ± 5, Day 150 ± 5, Day 180 ± 5, Day 210 ± 7, Day 240 ± 7, Day 270 ± 7, Day 300 ± 7, Day 330 ± 7, Day 360 ± 7.

Study Arms (2)

iovera system

ACTIVE COMPARATOR

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.

Device: iovera system

Radiofrequency ablation

ACTIVE COMPARATOR

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

Device: Radiofrequency ablation alone

Interventions

iovera system DEVICE

Reusable, portable Handpiece, along with single patient use sterile Smart Tips (i.e., cryoprobes) and disposable nitrous oxide (N2O) cartridges. The iovera° system produces the desired effect through initiation of a cooling cycle. Each cooling cycle is initiated by fully inserting the Smart Tip into the selected procedure site and activating the cryogen flow. The Smart Tip needles are made of stainless steel and have a closed tip, fully enclosing the cryogen. The STT21180STIM Smart Tip will be used in this study.

Also known as: Cryoneurolysis

iovera system

Radiofrequency ablation alone DEVICE

An electrode at the tip of the needle sends radio waves that lesion the nerve bundles.

Also known as: Ablation

Radiofrequency ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects at least 18 years of age at Screening
• Chronic low back pain (≥ 3 months)
• Successful trial of two diagnostic medial branch blocks
• Failure of at least three months of conservative non-operative therapy (e.g., physical therapy, chiropractic care, sleep hygiene, weight loss, spinal injections, NSAIDs, physician-directed exercise program or other appropriate pain medicine)
• Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments

You may not qualify if:

• Active workers' compensation, personal injury, Social Security disability insurance (SSDI), or other litigation/compensation related to the spine
• Infection in the back or open wounds in the back
• Cancer
• Fractures in the back
• Pain shooting down the leg
• Pain when walking up/downhill
• Any back surgery or metal objects in the back
• Any implants of any kind in the body
• Currently pregnant, nursing, or planning to become pregnant during the study
• Blood clots
• History of RFA treatment in back
• Drug abuse

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

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MeSH Terms

Interventions

Radiofrequency Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Neil A Segal, MS, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, investigators, clinician, assessors and biostatistician are blinded to the treatment allocation through use of physical blinds to the intervention being administered and coded participant ID's.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, double-blind, randomized controlled trial

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: February 3, 2025
• Study Start: May 13, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)