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

Low Back Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00484159
• Other study ID #: NA_00007158
• Status: Completed
• Phase: N/A
• First received: June 6, 2007
• Last updated: July 25, 2011
• Start date: February 2007
• Est. completion date: January 2009

Study information

• Verified date: January 2009
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Lumbar zygapophysial (facet) joints are recognized as one of the most common causes of chronic low back pain with an estimated prevalence among patients with LBP ranging from 15% to 40%. Radiofrequency (RF) denervation of facet joints has been utilized as an effective treatment of chronic pain attributed to these joints. Blocks of the medial branches innervating the joints are commonly used to localize the pain and make a diagnosis of lumbar zygapophysial (l-z) joint pain. However, considering the high false-positive rates of these blocks (25-40%), the false-negative rates (8-10%), and the number of blocks necessary to make the diagnosis before treatment, the cost-effectiveness of performing these blocks and the benefit of exposing these patients to additional risks is under question. The risks of RF denervation are so low (equivalent to performing the diagnostic block), some have questioned whether or not any diagnostic facet blocks should be performed before RF lesioning.

The purpose of the study is to determine the optimal number of diagnostic blocks that should be performed before radiofrequency denervation in patients with chronic lower back pain with suspected facet joint etiology.

In this prospective randomized study, we will recruit 150 patients with suspected chronic (l-z) joint pain without neurological symptoms to undergo one of three treatment modalities. In group I, 50 patients will undergo RF denervation based on history and physical exam alone (what we advocate in a recent review article). In group II, 50 patients will receive a single diagnostic block with 0.5% bupivacaine. Those that obtain greater than 50% pain reduction will undergo RF denervation. In group III, 50 patients will receive a block with either 2% lidocaine or 0.5% bupivacaine. Those patients that obtain greater than 50% pain relief with the first block receive a second block with the other local anesthetic. Patients that obtain greater than 50% pain relief with the second block then undergo RF. Patients in any group that obtain less than 50% pain relief with any block exit the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Procedure:
• Radiofrequency denervation of medial branches
Radiofrequency of medial branches that innervate the lumbar facet joints

Drug:
• 0.5% bupivacaine
Diagnostic medial branch block with 0.5% bupivacaine. Blocking the nerves that innervate the facet joints with a long-acting local anesthetic.
• 2% lidocaine
Diagnostic medial branch block with 2% lidocaine. Blocking the nerves that innervate the facet joints with a short-acting local anesthetic.

Procedure:
• Radiofrequency denervation
Radiofrequency lumbar facet denervation without a diagnostic block
• Radiofrequency denervation
Radiofrequency lumbar facet denervation only if positive response to 2 diagnostic blocks.
• Radiofrequency denervation
Lumbar facet radiofrequency denervation if positive response to a single diagnostic facet block
• Radiofrequency denervation
Radiofrequency lumbar facet denervation without a diagnostic facet block.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Walter Reed Army Medical Center	Washington, D.C.	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost Per Successful Procedure	Total cost per effective treatment at 3-months. Successful procedure defined as greater or equal to 50% pain relief and satisfaction lasting at least 3 months.	3-months	No
Secondary	Successful Treatment	Greater or equal to 50% pain relief plus procedural satisfaction lasting at least 3 months. What is being measured is the number of participants with a positive outcome.	3-months postprocedure	No