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

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

Overview

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.

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.

Interventions

• Device 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 u
• Device Radiofrequency ablation alone
  An electrode at the tip of the needle sends radio waves that lesion the nerve bundles.

Primary outcome measures

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

Secondary outcome measures (12)

• 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Kansas Medical Center — Kansas City

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. PMID 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. PMID 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. PMID 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. PMID 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 PMID 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. PMID 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. PMID 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. PMID 28336454

Identifiers

NCT: NCT06804551 · STUDY00160986

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗