N/A
Completed 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
Source: ClinicalTrials.gov NCT03614793 ↗
Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: Numeric Pain Rating Scale (NPRS) — 14; 3 Participants
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.
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 |
— | — |
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. Informational only — not medical advice.