Cooled RFA vs Conventional RFA to Manage Chronic Facetogenic Low Back Pain (NCT04803149) | Clinical Trial Compass
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Cooled RFA vs Conventional RFA to Manage Chronic Facetogenic Low Back Pain
United States79 participantsStarted 2021-02-23
Plain-language summary
This study is being conducted to assess the relative effectiveness of radiofrequency neurotomy in subjects with chronic axial low back pain originating in the lumbar facet joints using the COOLIEF\* Cooled Radiofrequency Probe as compared to the same procedure conducted using a Standard Radiofrequency Probe.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 21 years
. Able to understand the informed consent form and provide written informed consent and able to complete outcome measures.
. Subjects who have chronic axial (non-radicular) low back pain (at least 3 months) attributed to bilateral L4/L5, L5/S1 lumbar facet joint arthropathy based on clinical evaluation (paraspinal tenderness in the absence of signs and symptoms suggestive of focal neurological deficits) despite conservative treatments, including activity modification, home exercise, protective weight bearing, and/or analgesics (for example, acetaminophen or non-steroidal anti-inflammatory drugs \[NSAIDs\]).
. Positive response to dual diagnostic medial branch blocks (defined as a decrease in numeric pain scores of at least 80% for a min of 3 hours for bupivacaine and minimum of 2 hours for lidocaine) using 0.5mL or less of 0.5% bupivacaine and 2% lidocaine, on respective encounters on separate days, at each of the appropriate medial branches.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The proportion of subjects whose back pain is reduced by ≥ 50 percent based on the NRS scale at 6 Months
Timeframe: 6 months
2
Proportion of subjects experiencing adverse events through 6-months
. Usual/Average Pain ≥ 6 on an 11-point NRS scale.
. Analgesics including membrane stabilizers such as Neurontin (gabapentin) and antidepressants for pain, such as Cymbalta (duloxetine), must be clinically stable (defined as stable dosage for ≥ 6 weeks prior to the screening visit) and shall not change during the study without approval of the investigator.
. Agree to see one physician (study physician) for back pain during the study period.
. Subjects of child bearing potential must be willing to utilize double barrier contraceptive method for duration of participation.
Exclusion criteria
. Evidence of inflammatory arthritis (example, rheumatoid arthritis) or other systemic condition (example; gout, fibromyalgia, MS, Lupus, etc.) that could cause pain.
. Focal neurologic signs or symptoms.
. Spinal pathology that may impede recovery such as spina bifida occulta, grade II or higher spondylolisthesis at an affected joint or adjacent level, or significant lumbar scoliosis (sagittal vertical axis angle \>5 degrees or Cobb Angle \>10 degrees).
. Suspected mechanical instability based on flexion/extension and/or films at the proposed treatment levels
. History of prior lumbar fusion or previous lumbar back surgery at the intended treatment levels.
. Progressive motor deficit, and/or clinical signs of cauda equina or polyradiculopathy.
. Radiologic evidence of a symptomatic herniated disc or nerve root impingement.
. Symptomatic moderate or severe foramina or central canal stenosis demonstrating radicular symptoms or neurogenic claudication.