|Principal Investigator: Zachary McCormick|
|Keywords: cooled radiofrequency ablation , lumbar facet joint pain , facet joint injection , lumbar pain||Department: Physical Medicine & Rehab|
|IRB Number: 00119821||Co Investigator: Nick Monson|
|Specialty: Physical Medicine and Rehabilitation|
|Sub Specialties: Back|
|Recruitment Status: Not yet recruiting|
1. What percent of patients diagnosed with lumbar facet syndrome, who have had two positive medial branch nerve blocks and minimal response, and a short-term response to zygapophyseal (“facet”) joint injection of corticosteroid, then experience durable clinically significant pain relief, functional improvement, and reduction of analgesic medication use following treatment with cooled radiofrequency ablation? 2. What percent of patients diagnosed with lumbar facet syndrome, who have had two positive medial branch nerve blocks and minimal response, and a short-term response to cooled radiofrequency ablation, then experience durable clinically significant pain relief functional improvement, and reduction of analgesic medication use following facet joint injection of corticosteroid?
- Adult patients aged > 40 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 (i.e. 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.
- Facet joint injection with poor or short-term response rate.
- RFA with poor or short-term response rate.
- Scheduled for cooled radiofrequency ablation procedure within 3 months of facet joint injection as standard of care.
- Scheduled for facet joint steroid injection within 3 months of radiofrequency ablation procedure.
- 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 placement of other hardware.
- Grade 2 Spondylolisthesis at an affected or adjacent level.
- Cobb angle >10 degrees.
- Sagittal vertical axis angle >5 degrees.
- BMI >35.
- Cognitive deficit affecting ability to complete the assessment instruments.
- Inability to read English and complete the assessment instruments.
- Allergy to local anesthetics.
- Chronic widespread pain or somatoform disorder (e.g. fibromyalgia).
- Prior lumbar MBN radiofrequency neurotomy.
- Addictive behavior, severe clinical depression, anxiety, or any mental health condition with psychotic features.
- Possible pregnancy or other reason that precludes the use of fluoroscopy.
- Daily chronic opiate use of >50 morphine equivalents.
- Longer than 3 months between facet joint injection and cooled radiofrequency ablation.
There are no direct benefits or reimbursement to the individual by participating in this study. The patients will be presented with the same options of treatment whether they enroll in the study or decide not to.