Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Chronic Low Back Pain
NCT ID: NCT06804551
Last Updated: 2025-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2025-04-07
2026-05-31
Brief Summary
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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.
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Detailed Description
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Study Procedures are Radiofrequency ablation (RFA) and the iovera° system. The site investigators will be trained to perform RFA and to use the iovera° device and a single unblinded research team member will administer the iovera° procedure. The procedure administering investigator(s) will not perform any of the study-specific assessments.
Post-treatment:
After the study procedure, subjects will be instructed to take their prescribed pain medications (i.e., opioid and non-opioid) as needed in response to their pain experience and record their pain score before taking their medication.
Subjects must be instructed to report any adverse device effects and adverse events (AEs) to the Investigator from the time the ICF is signed through Day 360 (±7 days). Safety will be assessed while subjects are in the facility. The total duration of study follow-up will 360 days (± 7 days). Adverse device effects, serious adverse device effects, adverse events, and serious adverse events will be recorded from the time the ICF is signed through Day 360 (± 7 days). Any concomitant medications used to treat AEs through postsurgical Day 360 (± 7 days) will also be recorded.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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iovera system
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.
iovera system
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.
Radiofrequency ablation
Utilizes radiofrequency energy to heat and denature the target medial branch nerve supplying the facet joint.
Radiofrequency ablation alone
An electrode at the tip of the needle sends radio waves that lesion the nerve bundles.
Interventions
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iovera system
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.
Radiofrequency ablation alone
An electrode at the tip of the needle sends radio waves that lesion the nerve bundles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Kansas Medical Center
OTHER
Responsible Party
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Principal Investigators
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Neil A Segal, MS, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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University of Kansas Medical Center
Kansas City, Kansas, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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STUDY00160986
Identifier Type: -
Identifier Source: org_study_id
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