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

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.

Conditions

• Low Back Pain

Interventions

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.

DRUG

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

PROCEDURE

Radiofrequency denervation

Radiofrequency lumbar facet denervation only if positive response to 2 diagnostic blocks.

PROCEDURE

Radiofrequency denervation

Lumbar facet radiofrequency denervation if positive response to a single diagnostic facet block

PROCEDURE

Radiofrequency denervation

Radiofrequency lumbar facet denervation without a diagnostic facet block.

Sponsors & Collaborators

• Johns Hopkins University

  lead OTHER

Principal Investigators

• Steven P Cohen, MD · Johns Hopkins School of Medicine, Walter Reed Army Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-02-28

Primary Completion

2009-01-31

Completion

2009-01-31

Countries

• United States

Study Locations