Low Back Pain, ChronicNCT07214844
A Prospective Study to Evaluate the Efficacy of Iovera Lumbar Medial Branch Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Chronic Low Back Pain
A study testing Iovera Medial Branch Cryoneurolysis and Radiofrequency ablation (RFA) in people with Low Back Pain, Chronic, run by Montefiore Medical Center at 1 site in United States.
Trial summary
A research study is being conducted to compare two treatments for long-term low back pain: One uses the iovera° system, which applies cold to certain nerves in the lower back. The other is the standard treatment called radiofrequency ablation, which uses heat. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Chronic
- What is being tested?
- Iovera Medial Branch Cryoneurolysis and Radiofrequency ablation (RFA)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2026to May 2028
- 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
Who may be able to join
- Subjects must meet all of the following inclusion criteria to be eligible for participation:
- Subjects at least 18 years of age at Screening
- Primary complaint of axial low-back pain suggestive of bilateral facet joint involvement (i.e., facet mediated CLBP) by evidence of provocative testing (e.g., axial loading, paraspinal tenderness)
- Low back pain is chronic (i.e., ≥ 3 months' duration)
- Low back pain is moderate to severe (score of ≥ 5 to ≤ 9) on the 0 to 10 NRS at Screening
- Low back pain causes functional impairment (≥ 30% on ODI) at Screening
Show all 9Show fewer
- Successful trial of two diagnostic medial branch blocks consisting of two positive blocks with local anesthetic only (i.e., no steroids) that results in at least 80% relief of primary (index) pain for the duration of the local anesthetic used
- 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 analgesics)
- Able to provide informed consent, adhere to the study visit schedule, and complete all study assessment
Who cannot join
- 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
- Serious spinal disorders (verified on magnetic resonance imaging (MRI)) that may impact outcomes, including any of the following:
- Suspected cauda equina syndrome (e.g., bowel/bladder dysfunction)
- Infection
- Tumor
Show all 38Show fewer
- Traumatic fracture
- Systemic inflammatory spondyloarthropathy
- Lumbar radiculopathy/radiculitis (i.e., root irritation and deficit)
- Neurogenic claudication Prior lumbar spinal fusion surgery at the intended treatment levels
- Comorbidity that, in the judgment of the Investigator, may affect the subject's ability to participate in the study including lumbar radiculopathy and neuropathic pain disorder
- Currently pregnant, nursing, or planning to become pregnant during the study
- Known contraindication to study device, including any of the following:
- Cryoglobulinemia
- Paroxysmal cold hemoglobinuria
- Cold urticaria
- Raynaud's disease
- Open and/or infected wounds at or near the treatment site
- Coagulopathy
- Severe chronic pain disorder that in the opinion of the investigator may impact study outcomes
- Presence of any of the following:
- Spinal neurostimulator
- Intrathecal analgesic drug pump
- Cardiac implantable device
- Current manifestation of poorly controlled mental illness or catastrophizing that in the opinion of the investigator may meaningfully impact treatment outcomes, including any of the following:
- Mood disorder (e.g., depression, bipolar)
- Patient Health Questionnaire (PHQ-9) ≥ 12 at Screening
- Psychotic disorder (e.g., schizophrenia)
- Catastrophizing
- Patient Catastrophizing Scale (PCS) score > 30 at Screening
- Subject received other spine intervention/therapies in the 30 days prior to block administration (e.g., spinal injections, minimally invasive therapies, surgical therapies) at the intended lumbar treatment levels
- Subject received radiofrequency ablation in the low back region ≤ 6 months before study enrollment at the intended lumbar treatment levels
- Pain relief following diagnostic medial branch blocks lasted longer than the duration of the local anesthetic used (i.e., > 24 hours)
- History, suspicion, or clinical manifestation of:
- Alcohol abuse or dependence
- Illicit drug use
- Opioid abuse or dependence (≥40 mg medication PO/day in past 30 days)
- Given the COVID-19 pandemic, the subject must be medically fit/cleared for surgery by the investigator. If there is a concern about a subject's recent or potential exposure to COVID-19, or if the subject is not medically fit/cleared for surgery due to suspected COVID-19 illness/symptoms (or other serious illness), the subject must be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Montefiore Multidisciplinary Pain Program
The Bronx, New York, 10461
Karina Gritsenko, MD, 609-369-0344, kgritsen@montefiore.org
Rafi Khandaker, BA, 9297152343, rkhandaker@montefiore.org
About this study
Official title: A Prospective, Randomized, Assessor Blind, Active-controlled, Single-center Study to Evaluate the Efficacy of Iovera Lumbar Medial Branch Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Facet-mediated Chronic Low Back Pain
A research study is being conducted to compare two treatments for long-term low back pain:
- One uses the iovera° system, which applies cold to certain nerves in the lower back.
- The other is the standard treatment called radiofrequency ablation, which uses heat.
The primary objective is to find out which treatment works better to reduce back pain. Participants in this study will be randomly placed in one of the two treatment groups. The clinical research team will check on participant pain levels and overall health before and after the procedure for about 12 months. The entire study will last about 14 months for each participant.
Read the detailed description
Secondary objectives of this study include:
- Evaluate safety outcomes (i.e., adverse device effects, serious adverse device effects, and adverse events) related to iovera° treatment;
- Evaluate clinical outcomes related to iovera° treatment including pain, functional disability, and concomitant medication use (including opioids and analgesics);
- Evaluate the treatment success and failure rate of iovera° medial branch cryoneurolysis;
- Evaluate health-related quality of life (HRQoL);
- Evaluate subject satisfaction with pain management;
- Identify subgroups of patients who are most and least likely to benefit from iovera° medial branch cryoneurolysis for facet-mediated CLBP.
An adaptive study design will be used in this study. A blinded interim analysis will occur after approximately 56 total subjects, at least 28 per study arm, have completed assessment data for the primary efficacy outcome. The primary purpose of this interim analysis is to evaluate the sample size assumptions.
- Conditions
- Low Back Pain, Chronic
- Being tested
- Iovera Medial Branch Cryoneurolysis, Radiofrequency ablation (RFA)
- Keywords
- Iovera, Radiofrequency ablation, cryoneurolysis, low back pain, lumbar medial branch
- Medical subject headings
- Low Back Pain, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iovera Medial Branch CryoneurolysisDevice
The iovera group will receive fluoroscopic guided medial branch cryoneurolysis with the subject in the prone position under asepsis:
- Investigator injects 1% lidocaine at the treatment site using a 25-gauge, 3/4 -inch needle to numb the skin and tissue around the facet joint
- Introducer needle is inserted through the skin wheal to the target medial branch nerve below the junction of the superior articular and transverse process
- The introducer needle is positioned, and an x-ray image is taken to confirm the needle's position
- With the desired introducer needle position confirmed, the iovera Smart Tip is guided through the introducer needle and the handpiece is secured to the Smart Tip. The start/stop button on the iovera° handpiece is then pressed to start the cycle.
- After the cycle is complete, Smart Tip can be removed and next treatment cycle can commence ensuring an overlap of the ice ball
- The needle is removed, and light compression is applied with gauze
Radiofrequency ablation (RFA)Procedure or surgery
Subjects will receive a fluoroscopic guided RFA medial branch block in the prone position under asepsis:
- The Right L4, L5, S1 articular pillars are identified with fluoroscopy at each level and the target points are located
- A skin wheal is formed using 5mL 1% Lidocaine and 5mL 0.25% Bupivacaine
- A 20-gauge, 10cm needle with a 10mm active tip is inserted using a 15-degree oblique view and a 15-degree caudad angle onto the waist of each pillar at each level
- Anterior-posterior and oblique neuroforamen views confirm positioning
- Stimulation is performed and recorded to confirm proper needle placement
- A mixture of 3mL of 0.25% Bupivacaine and 2mL of 1% Lidocaine is divided and injected at each level
- A lesion is then performed at each level at 80 degrees centigrade for 60 seconds
- The needles are removed, and bandages applied to the puncture sites
- The same procedure is carried out on the opposite side
| Study group | Role | What they receive |
|---|---|---|
| iovera cryoneurolysis | Experimental | Subjects will receive iovera cryoneurolysis to the medial branch nerves of the lumbar spine. Receives: Device: Iovera Medial Branch Cryoneurolysis |
| Radiofrequency ablation (RFA) | Active comparator | Subjects will receive radiofrequency ablation (RFA) to the medial branch nerves of the lumbar spine. Receives: Procedure: Radiofrequency ablation (RFA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating scale (NRS) pain intensity score
Subjects will evaluate their pain in the low back region using an 11-point NRS where 0=no pain and 10=worst possible pain, such that higher scores are associated with greater pain intensity.
- Pain intensity scores (using the NRS) measured as "On a scale from 0 to 10, where 0 equals no pain and 10 equals the worst possible pain, how much pain are you experiencing in your low back right now?
- Pain intensity scores (using the numeric rating scale; NRS) measured as "On a scale from 0 to 10, where 0 equals no pain and 10 equals the worst possible pain, what was the worst pain in your low back in the last 24 hours?"
- Pain intensity scores (using the NRS) measured as "On a scale from 0 to 10, where 0 equals no pain and 10 equals the worst possible pain, what was the average pain in your low back in the last 24 hours?"
Mean numeric pain intensity rating scores will be summarized by study arm using basic descriptive statistics.
Measured: 360 days after intervention
Secondary outcomes (2)
Change in Functional Disability from baseline using Oswestry Disability Questionnaire
The Oswestry Disability Questionnaire is a 10-item condition-specific measure of functional status (pain and disability) for patients with low back pain (LBP). Each question has 6 possible answers (0 = worse, 5 = best). The raw score is doubled to provide a percent score from 0 to 100%; with 0 equaling no disability and 100% equaling the worst possible outcome. It measures pain-related disability. Change from baseline scores will be summarized by study arm using descriptive statistics.
Measured: 360 days after intervention
Change in Patients' Global Impression of Change (PGIC) scale from baseline
The Patient Global Impression of Change (PGIC) scale is a subjective measure used to evaluate a patient's perceived improvement following treatment, rated on a 7-point Likert scale ranging from 1 to 7 [1= "No change (or condition has got worse)" to 7 = "a great deal better, and a considerable improvement that has made all the difference"], wherein higher scores are associated with improved patient impression following treatment. Change from baseline scores will be summarized by study arm using descriptive statistics.
Measured: 360 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start16 Apr 2026
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Low Back Pain, ChronicStudies of the same condition, open and under way.
- More trials run by Montefiore 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
- 1:1 randomization
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- Responsible party
- Sponsor
- Investigators
- Karina Gritsenko, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214844
- Sponsor's protocol ID
- 2024-16365
- Other IDs
- CRS-133
- Status last verified
- Jun 2026
- First submitted
- 6 Oct 2025
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Leavitt L, Dixon B, Tieppo Francio V, Rohrs J, Hendrix JM. Radiofrequency Ablation. 2026 Jul 6. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482387/
PubMed 29494009Winston 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 33543059Tetzlaff 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 2500618Starr 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 30639589Shaffer 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 35601731Sayed 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 36510616Rubin 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 17445733Rubenstein 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 33105153Radnovich 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 28336454Perolat 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 30090998Mehta 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 22105690Manchikanti 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 19668291Manchikanti 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 32503359Katz 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 16595438GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8.
PubMed 30496104
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Assessor Blind, Active-controlled, Single-center Study to Evaluate the Efficacy of Iovera Lumbar Medial Branch Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Facet-mediated Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT07214844
- Acronym / sponsor ID
- 2024-16365
- Conditions
- Low Back Pain, Chronic
- Keywords
- Iovera, Radiofrequency ablation, cryoneurolysis, low back pain, lumbar medial branch
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- Study start
- 16 Apr 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 9 Oct 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.
A research study is being conducted to compare two treatments for long-term low back pain:
- One uses the iovera° system, which applies cold to certain nerves in the lower back.
- The other is the standard treatment called radiofrequency ablation, which uses heat.
The primary objective is to find out which treatment works better to reduce back pain. Participants in this study will be randomly placed in one of the two treatment groups. The clinical research team will check on participant pain levels and overall health before and after the procedure for about 12 months. The entire study will last about 14 months for each participant.
Detailed description
Secondary objectives of this study include:
- Evaluate safety outcomes (i.e., adverse device effects, serious adverse device effects, and adverse events) related to iovera° treatment;
- Evaluate clinical outcomes related to iovera° treatment including pain, functional disability, and concomitant medication use (including opioids and analgesics);
- Evaluate the treatment success and failure rate of iovera° medial branch cryoneurolysis;
- Evaluate health-related quality of life (HRQoL);
- Evaluate subject satisfaction with pain management;
- Identify subgroups of patients who are most and least likely to benefit from iovera° medial branch cryoneurolysis for facet-mediated CLBP.
An adaptive study design will be used in this study. A blinded interim analysis will occur after approximately 56 total subjects, at least 28 per study arm, have completed assessment data for the primary efficacy outcome. The primary purpose of this interim analysis is to evaluate the sample size assumptions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 randomization
| Arm | Type | Receives |
|---|---|---|
| iovera cryoneurolysis | Experimental | Device: Iovera Medial Branch CryoneurolysisSubjects will receive iovera cryoneurolysis to the medial branch nerves of the lumbar spine. |
| Radiofrequency ablation (RFA) | Active comparator | Procedure: Radiofrequency ablation (RFA)Subjects will receive radiofrequency ablation (RFA) to the medial branch nerves of the lumbar spine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects must meet all of the following inclusion criteria to be eligible for participation:
- Subjects at least 18 years of age at Screening
- Primary complaint of axial low-back pain suggestive of bilateral facet joint involvement (i.e., facet mediated CLBP) by evidence of provocative testing (e.g., axial loading, paraspinal tenderness)
- Low back pain is chronic (i.e., ≥ 3 months' duration)
- Low back pain is moderate to severe (score of ≥ 5 to ≤ 9) on the 0 to 10 NRS at Screening
Key exclusion criteria (38 listed)
- 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
- Serious spinal disorders (verified on magnetic resonance imaging (MRI)) that may impact outcomes, including any of the following:
- Comorbidity that, in the judgment of the Investigator, may affect the subject's ability to participate in the study including lumbar radiculopathy and neuropathic pain disorder
- Currently pregnant, nursing, or planning to become pregnant during the study
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 Medial Branch CryoneurolysisThe iovera group will receive fluoroscopic guided medial branch cryoneurolysis with the subject in the prone position under asepsis: * Investigator injects 1% lidocaine at the treatment site using a 25-gauge, 3/4 -inch needle to numb the skin and tissue around the facet joint * Introducer needle is inserted through the skin wheal to the target medial branch nerve below the junction of the superior articular and transverse process * The introducer needle is positioned, and an x-ray image is taken to confirm the needle's position * With the desired introducer needle position confirmed, the iovera Smart Tip is guided through the introducer needle and the handpiece is secured to the Smart Tip. The start/stop button on the iovera° handpiece is then pressed to start the cycle. * After the cycle is complete, Smart Tip can be removed and next treatment cycle can commence ensuring an overlap of the ice ball * The needle is removed, and light compression is applied with gauze | Device | iovera cryoneurolysis |
| Radiofrequency ablation (RFA)Subjects will receive a fluoroscopic guided RFA medial branch block in the prone position under asepsis: * The Right L4, L5, S1 articular pillars are identified with fluoroscopy at each level and the target points are located * A skin wheal is formed using 5mL 1% Lidocaine and 5mL 0.25% Bupivacaine * A 20-gauge, 10cm needle with a 10mm active tip is inserted using a 15-degree oblique view and a 15-degree caudad angle onto the waist of each pillar at each level * Anterior-posterior and oblique neuroforamen views confirm positioning * Stimulation is performed and recorded to confirm proper needle placement * A mixture of 3mL of 0.25% Bupivacaine and 2mL of 1% Lidocaine is divided and injected at each level * A lesion is then performed at each level at 80 degrees centigrade for 60 seconds * The needles are removed, and bandages applied to the puncture sites * The same procedure is carried out on the opposite side | Procedure or surgery | Radiofrequency ablation (RFA) |
Primary outcome
Numeric rating scale (NRS) pain intensity score
Time frame: 360 days after intervention
Subjects will evaluate their pain in the low back region using an 11-point NRS where 0=no pain and 10=worst possible pain, such that higher scores are associated with greater pain intensity. * Pain intensity scores (using the NRS) measured as "On a scale from 0 to 10, where 0 equals no pain and 10 equals the worst possible pain, how much pain are you experiencing in your low back right now? * Pain intensity scores (using the numeric rating scale; NRS) measured as "On a scale from 0 to 10, where 0 equals no pain and 10 equals the worst possible pain, what was the worst pain in your low back in the last 24 hours?" * Pain intensity scores (using the NRS) measured as "On a scale from 0 to 10, where 0 equals no pain and 10 equals the worst possible pain, what was the average pain in your low back in the last 24 hours?" Mean numeric pain intensity rating scores will be summarized by study arm using basic descriptive statistics.
2 secondary outcomes
Change in Functional Disability from baseline using Oswestry Disability Questionnaire
Time frame: 360 days after intervention
Change in Patients' Global Impression of Change (PGIC) scale from baseline
Time frame: 360 days after intervention
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 17 Jun 2026.
- Background: PubMed 29494009Leavitt L, Dixon B, Tieppo Francio V, Rohrs J, Hendrix JM. Radiofrequency Ablation. 2026 Jul 6. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482387/
- 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.
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- Individual participant dataSharing planned: No
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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.
Karina Gritsenko, MD principal investigator
Montefiore 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 Medial Branch Cryoneurolysis and Radiofrequency ablation (RFA) in people with Low Back Pain, Chronic, run by Montefiore 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?
The sponsor lists 9 inclusion and 38 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 17 Jun 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?
Contact Karina Gritsenko, MD (609-369-0344, kgritsen@montefiore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric rating scale (NRS) pain intensity score (time frame: 360 days after intervention). 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 NCT07214844, which also lists 23 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 17 Jun 2026.