At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prospective Randomized Study Comparing 0, 1, and 2 Diagnostic Lumbar Medial Branch (Facet Joint) Blocks Before Radiofrequency Denervation in Patients With Chronic Low Back Pain: A Cost: Benefit Analysis.
In Brief
A clinical study evaluating Radiofrequency denervation of medial branches, 0.5% bupivacaine, and 2 other interventions for Low Back Pain. Completed, enrolled 151 participants across 2 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
Radiofrequency of medial branches that innervate the lumbar facet joints
Diagnostic medial branch block with 0.5% bupivacaine. Blocking the nerves that innervate the facet joints with a long-acting local anesthetic.
Diagnostic medial branch block with 2% lidocaine. Blocking the nerves that innervate the facet joints with a short-acting local anesthetic.
Radiofrequency lumbar facet denervation without a diagnostic block
Radiofrequency lumbar facet denervation only if positive response to 2 diagnostic blocks.
Lumbar facet radiofrequency denervation if positive response to a single diagnostic facet block
Radiofrequency lumbar facet denervation without a diagnostic facet block.