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

Not Applicable

Not yet recruiting

• Conditions: Chronic Low-back Pain

• Registration Number: NCT06804551
• Lead Sponsor: University of Kansas Medical Center

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.

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.

Study Timeline

• Study First Submitted: 2025-01-07
• Study First Submitted QC: 2025-01-27
• Study First Posted: 2025-03-25
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-02
• Study Start: 2025-04-07
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Confirm the feasibility of a double-blinded protocol	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.

Secondary Outcome Measures

Name	Time	Method
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.	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.
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.	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.
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.	This outcome will record the types, doses and frequencies for concomitant medications used (including opioids and analgesics).
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.	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.
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.	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"
Patients' 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.	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"
Patient satisfaction with pain management	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.	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"
Health Related Quality of Life	Screening, Day 90 ± 5, Day 180 ± 5, Day 270 ± 7, Day 360 ± 7.	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).
Pain Catastrophizing	Screening, Day 90 ± 5, Day 180 ± 5, Day 270 ± 7, Day 360 ± 7.	This outcome will be measured with the Pain Catastrophizing Scale with 0 being not al all to 4 being all the time.
Adverse device effects	This outcome will be recorded from the time the study ICF is signed through Day 360± 7 days.	The study team will keep a record a descriptive list of any adverse effects that occur pertaining to the device used in the study.
Adverse Events (AE's)	This outcome will be recorded from the time the study ICF is signed through Day 360± 7 days.	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.
serious adverse events (SAEs)	This outcome will be recorded from the time the study ICF is signed through Day 360± 7 days.	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.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States