Efficacy and Cost: Benefit Ratio of 0, 1, and 2 Medial Branch Blocks for Lumbar Facet Joint Radiofrequency Denervation
Completed · Not applicable
Conditions studied: Low Back Pain
In brief
Lumbar zygapophysial (facet) joint pain is a common cause of low back pain. Radiofrequency (RF) denervation is an effective and low risk treatment of chronic low back pain of suspected facet joint etiology. Blocks of the medial branches innervating the joints are commonly used to localize the pain and make the diagnosis of facet joint pain. There is currently no standard number of diagnostic blocks: zero, one, and two blocks have all been utilized. Considering the high false positive and false negative rates of these blocks, the cost: benefit ratio has been questioned. No study to date has examined the practice of diagnostic medial branch blocks before RF denervation. The purpose of this study is to determine the optimal number of blocks before radiofrequency denervation. Three groups of patients will be studied. In group I, patients will undergo RF denervation based on history and physical exam alone. In group II, patients will undergo RF denervation based on a positive response to a single diagnostic block with local anesthetic. In group III, patients will undergo RF treatment only after a positive screening block and a positive confirmatory block.
Key facts
- Study ID
- NCT00484159
- Run by
- Johns Hopkins University
- People needed
- 151
- Starts
- 2007-02-01
- Expected to finish
- 2009-01-01
- Last updated by the study team
- 2011-07-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Axial low back pain unresponsive to conservative treatment measures such as physical therapy, manual therapy and pharmacotherapy
- Duration of pain greater than 6 months
You may not qualify if…
- Age younger than 18 years
- Objective evidence (MRI or physical exam findings) of lumbosacral radiculopathy
- Prior radiofrequency treatment
- Significant spinal stenosis or spondylolisthesis
- Previous back surgery
- Uncorrected coagulopathy
- Unstable medical or psychiatric condition
- Pregnancy
- Allergies to local anesthetic
Where it is running
- Walter Reed Army Medical Center — Washington D.C., District of Columbia, United States
- Johns Hopkins Hospital — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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