Efficacy and Cost: Benefit Ratio of 0, 1, and 2 Medial Branch Blocks for Lumbar Facet Joint Radiofrequency Denervation
CompletedNot applicableNCT00484159
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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
- Official title
- 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.
- Conditions
- Interventions
- Procedure: Radiofrequency denervation of medial branches
- Drug: 0.5% bupivacaine
- Drug: 2% lidocaine
- Procedure: Radiofrequency denervation
- Procedure: Radiofrequency denervation
- Procedure: Radiofrequency denervation
- Procedure: Radiofrequency denervation
- Sponsor
- Johns Hopkins University
- Start date
- 2007-02
- Primary completion
- 2009-01
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Axial low back pain unresponsive to conservative treatment measures such as physical therapy, manual therapy and pharmacotherapy * Duration of pain greater than 6 months Exclusion Criteria: * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00484159