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N/A N=151 Randomized Treatment

Efficacy and Cost: Benefit Ratio of 0, 1, and 2 Medial Branch Blocks for Lumbar Facet Joint Radiofrequency Denervation

Low Back Pain

Enrolled (actual)
151
Serious AEs
0.0%
Results posted
Jul 2011
Primary outcome: Primary: Cost Per Successful Procedure — 15,241; 17,142; 6286 U.S. dollars

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Radiofrequency denervation of medial branches (Procedure); 0.5% bupivacaine (Drug); 2% lidocaine (Drug); Radiofrequency denervation (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Johns Hopkins University
Primary completion
Jan 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Cost Per Successful Procedure
15,241; 17,142; 6286
SECONDARY
Successful Treatment
9; 7; 17

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00484159). 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.

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