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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
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.
An electrode at the tip of the needle sends radio waves that lesion the nerve bundles.
University of Kansas Medical Center
Kansas City, Kansas, United States
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.
Time frame: After the last End of Study Visit
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.
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
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.
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
This outcome will record the types, doses and frequencies for concomitant medications used (including opioids and analgesics).
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
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.
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
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"
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
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"
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
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"
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
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: This outcome will be recorded from the time the study ICF is signed through Day 360± 7 days.
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