Chronic Low-back PainNCT06804551

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

A study testing iovera system and Radiofrequency ablation alone in people with Chronic Low-back Pain, run by University of Kansas Medical Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Low-back Pain
What is being tested?: iovera system and Radiofrequency ablation alone
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 13 May 2025to Jul 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Inclusion Criteria: Subjects must meet all the following inclusion criteria to be eligible for participation.

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

Exclusion Criteria: Subjects who meet any of the following exclusion criteria will not be eligible for participation in this study.

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Kansas Medical Center
Kansas City, Kansas, 66160

Other trials in United States

About this study

Official title: A Single-center, Prospective, Double-blind, Randomized Controlled Trial Evaluating Iovera° Lumbar Medial Branch Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Facet-mediated Chronic Low Back Pain

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.

Read the detailed description

Potential subjects will be screened within 30 days prior to the iovera° treatment. After the Informed Consent Form (ICF) is signed, demographic information (including the Pain Catastrophizing Scale (PCS), Oswestry Disability index (ODI), and Patient Health Questionnaire (PHQ-9)), medical and surgical history, concomitant medications/concurrent procedures information, and vital signs will be collected. An assessment of the intended treatment areas will be conducted. Subjects will assess the pain in their low back region using a Numeric Rating Scale (NRS) and health-related quality of life (EQ-5D-5L) at the screening visit. When screening test results are received and the subject is deemed eligible for the study, the subject will be notified that he or she is enrolled in the study and will receive study procedure.

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: Chronic Low-back Pain
Being tested: iovera system, Radiofrequency ablation alone
Keywords: iovera, radiofrequency ablation, medial branch block, chronic low back pain, cryoneurolysis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

iovera systemDevice
Also called Cryoneurolysis
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 aloneDevice
Also called Ablation
An electrode at the tip of the needle sends radio waves that lesion the nerve bundles.

Study groups in NCT06804551
Study group	Role	What they receive
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. Receives: Device: iovera system
Radiofrequency ablation	Active comparator	Utilizes radiofrequency energy to heat and denature the target medial branch nerve supplying the facet joint. Receives: Device: Radiofrequency ablation alone

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: After the last End of Study Visit

Secondary outcomes (12)

Current pain intensity scores in the low back region
Current pain: subjects will be asked "How much pain are you experiencing in your low back right now?"
This outcome measures current pain intensity (i.e., pain "right now" in the low back region) using an 11-point Numeric Rating Scale (NRS) instrument in which 0 =no pain and 10 =the worst pain imaginable.
Measured: 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
Daily pain: subjects will be asked "What was your worst pain in the past 24 hours in your low back?" and "What was your average pain in the last 24 hours in your low back?"
This outcome measures daily pain intensity (i.e., average / worst pain over the past 24 hours in the low back region) using an 11-point Numeric Rating Scale (NRS) instrument in which 0 =no pain and 10 =the worst pain imaginable.
Measured: 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
This outcome will record the types, doses and frequencies for concomitant medications used (including opioids and analgesics).
Measured: 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
This outcome will be measured using the Oswestry Disability Index (ODI) Questionnaire; the ODI ranges from 0 to 100. A higher score on the ODI indicates a more severe disability caused by low back pain.
Measured: 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
This outcome will be measured using the 7-point Patient Global Impression of Change scale regarding change:
Participants will be asked:
"Since beginning treatment at this clinic, how would you describe the change (if any) in activity libations, symptoms, emotions, and overall quality of life, related to your painful condition? (circle one number below):
1. No change (or condition has gotten worse)
2. Almost the same, hardly any change at all
3. A little better, but no noticeable change
4. Somewhat better, but the change has not made any real difference
5. Moderately better and a slight but noticeable change
6. Better, and definite improvement that has made a real and worthwhile difference
7. A great deal better, and a considerable improvement that has made all the difference"
Measured: 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' impression of change
This outcome will be measured using the additional 0-10 point question regarding change:
Participants will be asked:
"Please circle the number (0-10) that matches your degree of change since the beginning of care at this study: 0 being much better 5 being no change 10 being much worse"
Measured: 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.
Patient satisfaction with pain management
This outcome will be measured with the following scale:
"Please circle the number below that best describes your overall satisfaction with your pain management. (Select one number only)
1. Extremely dissatisfied
2. Dissatisfied
3. Neither satisfied nor dissatisfied
4. Satisfied
5. Extremely satisfied"
Measured: 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.
Health Related Quality of Life
This outcome will be measured with the EuroQol (EQ-5D-5L) Validity in Assessing the Quality of Life Questionnaire, a 5 question questionnaire regarding quality of life, with higher values being better health and lower values being worse health).
Measured: Screening, Day 90 ± 5, Day 180 ± 5, Day 270 ± 7, Day 360 ± 7.
Pain Catastrophizing
This outcome will be measured with the Pain Catastrophizing Scale with 0 being not al all to 4 being all the time.
Measured: Screening, Day 90 ± 5, Day 180 ± 5, Day 270 ± 7, Day 360 ± 7.
Adverse device effects
The study team will keep a record a descriptive list of any adverse effects that occur pertaining to the device used in the study.
Measured: This outcome will be recorded from the time the study ICF is signed through Day 360± 7 days.
Adverse Events (AE's)
The study team will keep a record of any adverse effects that occur pertaining the participants enrolled in the study. CTCAE v5.0 will be used to classify AE's.
Measured: This outcome will be recorded from the time the study ICF is signed through Day 360± 7 days.
serious adverse events (SAEs)
The study team will keep a record of any serious adverse events that occur pertaining the participants enrolled in the study. CTCAE v5.0 will be used to classify SAE's.
Measured: This outcome will be recorded from the time the study ICF is signed through Day 360± 7 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 May 2025Jul 2027

First posted3 Feb 2025
Study start13 May 2025
Primary completionJul 2027 (estimated)
Study completionJul 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (22)Papers the sponsor has linked to this study.
Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Prospective, double-blind, randomized controlled trial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06804551
Sponsor's protocol ID: STUDY00160986
Status last verified: Oct 2026
First submitted: 7 Jan 2025
Last updated: 8 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Winston P, Mills PB, Reebye R, Vincent D. Cryoneurotomy as a Percutaneous Mini-invasive Therapy for the Treatment of the Spastic Limb: Case Presentation, Review of the Literature, and Proposed Approach for Use. Arch Rehabil Res Clin Transl. 2019 Oct 17;1(3-4):100030. doi: 10.1016/j.arrct.2019.100030. eCollection 2019 Dec.
PubMed 33543059
Tetzlaff W, Bisby MA. Neurofilament elongation into regenerating facial nerve axons. Neuroscience. 1989;29(3):659-66. doi: 10.1016/0306-4522(89)90138-3.
PubMed 2500618
Starr JB, Gold L, McCormick Z, Suri P, Friedly J. Trends in lumbar radiofrequency ablation utilization from 2007 to 2016. Spine J. 2019 Jun;19(6):1019-1028. doi: 10.1016/j.spinee.2019.01.001. Epub 2019 Jan 10.
PubMed 30639589
Shaffer JP, Williams VB, Shin SS. Cryoneurolysis for Digital Neuralgia in Professional Baseball Players: A Case Series. Orthop J Sports Med. 2022 May 12;10(5):23259671221096095. doi: 10.1177/23259671221096095. eCollection 2022 May.
PubMed 35601731
Sayed D, Grider J, Strand N, Hagedorn JM, Falowski S, Lam CM, Tieppo Francio V, Beall DP, Tomycz ND, Davanzo JR, Aiyer R, Lee DW, Kalia H, Sheen S, Malinowski MN, Verdolin M, Vodapally S, Carayannopoulos A, Jain S, Azeem N, Tolba R, Chang Chien GC, Ghosh P, Mazzola AJ, Amirdelfan K, Chakravarthy K, Petersen E, Schatman ME, Deer T. The American Society of Pain and Neuroscience (ASPN) Evidence-Based Clinical Guideline of Interventional Treatments for Low Back Pain. J Pain Res. 2022 Dec 6;15:3729-3832. doi: 10.2147/JPR.S386879. eCollection 2022.
PubMed 36510616
Rubin DI. Epidemiology and risk factors for spine pain. Neurol Clin. 2007 May;25(2):353-71. doi: 10.1016/j.ncl.2007.01.004.
PubMed 17445733
Rubenstein J, Harvey AW, Vincent D, Winston P. Cryoneurotomy to Reduce Spasticity and Improve Range of Motion in Spastic Flexed Elbow: A Visual Vignette. Am J Phys Med Rehabil. 2021 May 1;100(5):e65. doi: 10.1097/PHM.0000000000001624. No abstract available.
PubMed 33105153
Radnovich R, Scott D, Patel AT, Olson R, Dasa V, Segal N, Lane NE, Shrock K, Naranjo J, Darr K, Surowitz R, Choo J, Valadie A, Harrell R, Wei N, Metyas S. Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial. Osteoarthritis Cartilage. 2017 Aug;25(8):1247-1256. doi: 10.1016/j.joca.2017.03.006. Epub 2017 Mar 20.
PubMed 28336454
Perolat R, Kastler A, Nicot B, Pellat JM, Tahon F, Attye A, Heck O, Boubagra K, Grand S, Krainik A. Facet joint syndrome: from diagnosis to interventional management. Insights Imaging. 2018 Oct;9(5):773-789. doi: 10.1007/s13244-018-0638-x. Epub 2018 Aug 8.
PubMed 30090998
Mehta CR, Pocock SJ. Adaptive increase in sample size when interim results are promising: a practical guide with examples. Stat Med. 2011 Dec 10;30(28):3267-84. doi: 10.1002/sim.4102. Epub 2010 Nov 30.
PubMed 22105690
Manchikanti L, Singh V, Datta S, Cohen SP, Hirsch JA; American Society of Interventional Pain Physicians. Comprehensive review of epidemiology, scope, and impact of spinal pain. Pain Physician. 2009 Jul-Aug;12(4):E35-70.
PubMed 19668291
Manchikanti L, Kaye AD, Soin A, Albers SL, Beall D, Latchaw R, Sanapati MR, Shah S, Atluri S, Abd-Elsayed A, Abdi S, Aydin S, Bakshi S, Boswell MV, Buenaventura R, Cabaret J, Calodney AK, Candido KD, Christo PJ, Cintron L, Diwan S, Gharibo C, Grider J, Gupta M, Haney B, Harned ME, Helm Ii S, Jameson J, Jha S, Kaye AM, Knezevic NN, Kosanovic R, Manchikanti MV, Navani A, Racz G, Pampati V, Pasupuleti R, Philip C, Rajput K, Sehgal N, Sudarshan G, Vanaparthy R, Wargo BW, Hirsch JA. Comprehensive Evidence-Based Guidelines for Facet Joint Interventions in the Management of Chronic Spinal Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines Facet Joint Interventions 2020 Guidelines. Pain Physician. 2020 May;23(3S):S1-S127.
PubMed 32503359
Katz JN. Lumbar disc disorders and low-back pain: socioeconomic factors and consequences. J Bone Joint Surg Am. 2006 Apr;88 Suppl 2:21-4. doi: 10.2106/JBJS.E.01273.
PubMed 16595438
Guirguis M, Hakkinen I, Amiri JP, Posas J. Cryotherapy. Deer's Treatment of Pain: Springer; 2019:283-289.
Evans PJ, Lloyd JW, Green CJ. Cryoanalgesia: the response to alterations in freeze cycle and temperature. Br J Anaesth. 1981 Nov;53(11):1121-7. doi: 10.1093/bja/53.11.1121.
PubMed 7326160

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain

All Chronic Low-back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-center, Prospective, Double-blind, Randomized Controlled Trial Evaluating Iovera° Lumbar Medial Branch Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Facet-mediated Chronic Low Back Pain
ClinicalTrials.gov ID: NCT06804551
Acronym / sponsor ID: STUDY00160986
Conditions: Chronic Low-back Pain
Keywords: iovera, radiofrequency ablation, medial branch block, chronic low back pain, cryoneurolysis
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 30 participants (estimated)
Lead sponsor: University of Kansas Medical CenterUniversity, hospital or other
Study start: 13 May 2025 (actual)
Primary completion: Jul 2027 (estimated)
Study completion: Jul 2027 (estimated)
First posted: 3 Feb 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Post-treatment:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Prospective, double-blind, randomized controlled trial

Arm	Type	Receives
iovera system	Active comparator	Device: iovera systemUses 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.
Radiofrequency ablation	Active comparator	Device: Radiofrequency ablation aloneUtilizes radiofrequency energy to heat and denature the target medial branch nerve supplying the facet joint.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
iovera systemAlso: CryoneurolysisReusable, 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.	Device	iovera system
Radiofrequency ablation aloneAlso: AblationAn electrode at the tip of the needle sends radio waves that lesion the nerve bundles.	Device	Radiofrequency ablation

Primary outcome

Confirm the feasibility of a double-blinded protocol
Time frame: After the last End of Study Visit
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.

12 secondary outcomes

Current pain intensity scores in the low back region
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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' impression of change
Time frame: 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.
Patient satisfaction with pain management
Time frame: 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.
Health Related Quality of Life
Time frame: Screening, Day 90 ± 5, Day 180 ± 5, Day 270 ± 7, Day 360 ± 7.
Pain Catastrophizing
Time frame: Screening, Day 90 ± 5, Day 180 ± 5, Day 270 ± 7, Day 360 ± 7.
Adverse device effects
Time frame: This outcome will be recorded from the time the study ICF is signed through Day 360± 7 days.
Adverse Events (AE's)
Time frame: This outcome will be recorded from the time the study ICF is signed through Day 360± 7 days.
serious adverse events (SAEs)
Time frame: This outcome will be recorded from the time the study ICF is signed through Day 360± 7 days.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
Background: PubMed 33543059Winston P, Mills PB, Reebye R, Vincent D. Cryoneurotomy as a Percutaneous Mini-invasive Therapy for the Treatment of the Spastic Limb: Case Presentation, Review of the Literature, and Proposed Approach for Use. Arch Rehabil Res Clin Transl. 2019 Oct 17;1(3-4):100030. doi: 10.1016/j.arrct.2019.100030. eCollection 2019 Dec.
Background: PubMed 2500618Tetzlaff W, Bisby MA. Neurofilament elongation into regenerating facial nerve axons. Neuroscience. 1989;29(3):659-66. doi: 10.1016/0306-4522(89)90138-3.
Background: PubMed 30639589Starr JB, Gold L, McCormick Z, Suri P, Friedly J. Trends in lumbar radiofrequency ablation utilization from 2007 to 2016. Spine J. 2019 Jun;19(6):1019-1028. doi: 10.1016/j.spinee.2019.01.001. Epub 2019 Jan 10.
Background: PubMed 35601731Shaffer JP, Williams VB, Shin SS. Cryoneurolysis for Digital Neuralgia in Professional Baseball Players: A Case Series. Orthop J Sports Med. 2022 May 12;10(5):23259671221096095. doi: 10.1177/23259671221096095. eCollection 2022 May.
Background: PubMed 36510616Sayed D, Grider J, Strand N, Hagedorn JM, Falowski S, Lam CM, Tieppo Francio V, Beall DP, Tomycz ND, Davanzo JR, Aiyer R, Lee DW, Kalia H, Sheen S, Malinowski MN, Verdolin M, Vodapally S, Carayannopoulos A, Jain S, Azeem N, Tolba R, Chang Chien GC, Ghosh P, Mazzola AJ, Amirdelfan K, Chakravarthy K, Petersen E, Schatman ME, Deer T. The American Society of Pain and Neuroscience (ASPN) Evidence-Based Clinical Guideline of Interventional Treatments for Low Back Pain. J Pain Res. 2022 Dec 6;15:3729-3832. doi: 10.2147/JPR.S386879. eCollection 2022.
Background: PubMed 17445733Rubin DI. Epidemiology and risk factors for spine pain. Neurol Clin. 2007 May;25(2):353-71. doi: 10.1016/j.ncl.2007.01.004.
Background: PubMed 33105153Rubenstein J, Harvey AW, Vincent D, Winston P. Cryoneurotomy to Reduce Spasticity and Improve Range of Motion in Spastic Flexed Elbow: A Visual Vignette. Am J Phys Med Rehabil. 2021 May 1;100(5):e65. doi: 10.1097/PHM.0000000000001624. No abstract available.
Background: PubMed 28336454Radnovich R, Scott D, Patel AT, Olson R, Dasa V, Segal N, Lane NE, Shrock K, Naranjo J, Darr K, Surowitz R, Choo J, Valadie A, Harrell R, Wei N, Metyas S. Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial. Osteoarthritis Cartilage. 2017 Aug;25(8):1247-1256. doi: 10.1016/j.joca.2017.03.006. Epub 2017 Mar 20.
Background: PubMed 30090998Perolat R, Kastler A, Nicot B, Pellat JM, Tahon F, Attye A, Heck O, Boubagra K, Grand S, Krainik A. Facet joint syndrome: from diagnosis to interventional management. Insights Imaging. 2018 Oct;9(5):773-789. doi: 10.1007/s13244-018-0638-x. Epub 2018 Aug 8.
Background: PubMed 22105690Mehta CR, Pocock SJ. Adaptive increase in sample size when interim results are promising: a practical guide with examples. Stat Med. 2011 Dec 10;30(28):3267-84. doi: 10.1002/sim.4102. Epub 2010 Nov 30.
Background: PubMed 19668291Manchikanti L, Singh V, Datta S, Cohen SP, Hirsch JA; American Society of Interventional Pain Physicians. Comprehensive review of epidemiology, scope, and impact of spinal pain. Pain Physician. 2009 Jul-Aug;12(4):E35-70.
Background: PubMed 32503359Manchikanti L, Kaye AD, Soin A, Albers SL, Beall D, Latchaw R, Sanapati MR, Shah S, Atluri S, Abd-Elsayed A, Abdi S, Aydin S, Bakshi S, Boswell MV, Buenaventura R, Cabaret J, Calodney AK, Candido KD, Christo PJ, Cintron L, Diwan S, Gharibo C, Grider J, Gupta M, Haney B, Harned ME, Helm Ii S, Jameson J, Jha S, Kaye AM, Knezevic NN, Kosanovic R, Manchikanti MV, Navani A, Racz G, Pampati V, Pasupuleti R, Philip C, Rajput K, Sehgal N, Sudarshan G, Vanaparthy R, Wargo BW, Hirsch JA. Comprehensive Evidence-Based Guidelines for Facet Joint Interventions in the Management of Chronic Spinal Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines Facet Joint Interventions 2020 Guidelines. Pain Physician. 2020 May;23(3S):S1-S127.
Individual participant dataSharing planned: No

Related trials for Chronic Low-back Pain

Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Neil A Segal, MS, MD principal investigator

University of Kansas Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing iovera system and Radiofrequency ablation alone in people with Chronic Low-back Pain, run by University of Kansas Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Confirm the feasibility of a double-blinded protocol (time frame: After the last End of Study Visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06804551, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.