A Prospective Trial of Cooled Radiofrequency Ablation of Medial Branch Nerves Versus Facet Joint … (NCT03614793) | Clinical Trial Compass
CompletedNot Applicable
A Prospective Trial of Cooled Radiofrequency Ablation of Medial Branch Nerves Versus Facet Joint Injection of Corticosteroid for the Treatment of Lumbar Facet Syndrome
United States39 participantsStarted 2018-10-01
Plain-language summary
Chronic, non-neurogenic low back pain (CLBP) is a common condition that affects many individuals across their lives. The lumbar facet joint has been implicated as an important source of CLBP, with a prevalence of 15-45%. Elements of clinical history, physical examination, and imaging (radiographs, standard CT scan, standard MRI sequences) provide poor diagnostic specificity for pain of lumbar zygapophysial joint (Z-joint) origin. Thus, clinicians have traditionally relied upon MBN blocks to confirm or refute this diagnosis. The reference standard for the diagnosis of lumbar Z-joint pain is a positive response to dual comparative MBN blocks, which requires pain reduction of great than or equal to 80% of concordant duration to that expected of two different local anesthetics on independent occasions. Further, dual comparative MBN blocks have a high positive predictive value for determining the clinical outcome of lumbar MBN RFA for the treatment of lumbar Z-joint pain; when patients are appropriately selected using this reference standard and rigorous MBN RFA technique is implemented according to practice guidelines, studies demonstrate excellent clinical outcomes.
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:
* Adult patients aged \> 21 capable of understanding and providing consent in English and capable of complying with the outcome instruments used.
* Axial (non-radicular) back pain for at least 3 months (ie Chronic Low Back Pain), with pain lasting at least half of the days within those 3 months, that did not respond to conventional treatment such as physical therapy, oral analgesic agents, and non-invasive adjunctive treatments. The pain can be unilateral or bilateral. The pain can also include referred lower limb pain.
* 7-day worst numeric pain rating score (NPRS) for back pain of 5/10 or greater at baseline evaluation.
* Positive responses to dual comparative diagnostic MBN blocks using 0.5mL of 0.5% bupivacaine and 4% lidocaine, on respective encounters on separate days, at each of the appropriate MBNs. The blocks are administered in a double-blind fashion so that neither the subject nor the independent assessor is aware of the local anesthetic used.
Exclusion Criteria:
* Focal neurologic signs or symptoms.
* Radiologic evidence of a symptomatic herniated disc or nerve root impingement related to spinal stenosis.
* Active systemic or local infections at the site of proposed needle and electrode placement.
* Coagulopathy or other bleeding disorder.
* Receipt of remuneration for their pain treatment (e.g. disability, worker's compensation, auto injury in litigation or pending litigation).
* History of any lumbar or lower thoracic fusion surgery or pla…
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.