N/A
N=39
A Prospective Trial of Cooled Radiofrequency Ablation of Medial Branch Nerves Versus Facet Joint Injection of Corticosteroid for the Treatment of Lumbar Facet Syndrome
Lumbar Facet Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03614793 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Numeric Pain Rating Scale (NPRS) — 14; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cooled Radiofrequency Ablation of Medial Branch Nerves versus Facet Joint Injection of Corticosteroid for the Treatment of Lumbar Facet Syndrome (Procedure)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numeric Pain Rating Scale (NPRS) |
14; 3 | — |
| SECONDARY Decrease in Oswestry Disability Index (ODI) Score |
3; 8 | — |
| SECONDARY Patient Global Impression of Change (PGIC) |
11; 4 | — |
| SECONDARY Numeric Pain Rating Scale (NPRS) Point Change |
13; 3 | — |
| SECONDARY Global Impression of Change (PGIC) |
— | — |
| SECONDARY Adverse Events |
— | — |
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.
Eligibility Criteria
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 placement of other hardware.
- > Grade 2 Spondylolisthesis at an affected or adjacent level.
- Cobb angle >10 degrees.
- Sagittal vertical axis angle >5 degrees
- BMI >40.
- Incarceration.
- 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.
Data sourced from ClinicalTrials.gov (NCT03614793). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.