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

Sponsor:	Johns Hopkins University
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00484159

Purpose

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.

Condition	Intervention
Low Back Pain	Procedure: Radiofrequency denervation of medial branches Drug: 0.5% bupivacaine Drug: 2% lidocaine Procedure: Radiofrequency denervation

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia Back Pain

Drug Information available for: Bupivacaine hydrochloride Bupivacaine Lidocaine

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

Cost per successful procedure [ Time Frame: Expected completion date June 2009. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pain scores and disability [ Time Frame: 3-months postprocedure ] [ Designated as safety issue: No ]

Enrollment:	151
Study Start Date:	February 2007
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Radiofrequency lumbar facet joint denervation only if positive response to 2 diagnostic facet blocks.	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 only if positive response to 2 diagnostic blocks.
2: Experimental Radiofrequency lumbar facet joint denervation if positive response to single facet joint block.	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. Procedure: Radiofrequency denervation Lumbar facet radiofrequency denervation if positive response to a single diagnostic facet block
3: Experimental Radiofrequency lumbar facet denervation without a diagnostic facet block.	Procedure: Radiofrequency denervation of medial branches Radiofrequency of medial branches that innervate the lumbar facet joints Procedure: Radiofrequency denervation Radiofrequency lumbar facet denervation without a diagnostic block Procedure: Radiofrequency denervation Radiofrequency lumbar facet denervation without a diagnostic facet block.

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484159

Locations

United States, District of Columbia
Walter Reed Army Medical Center
Washington, D.C., District of Columbia, United States, 20307
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator:

Steven P Cohen, MD

Johns Hopkins School of Medicine, Walter Reed Army Medical Center

More Information

No publications provided

Responsible Party:	Amanda Gibson ( Office of Research Administration )
Study ID Numbers:	NA_00007158
Study First Received:	June 6, 2007
Last Updated:	January 27, 2009
ClinicalTrials.gov Identifier:	NCT00484159 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Johns Hopkins University:

Low back pain of suspected lumbar zygapophysial etiology

Additional relevant MeSH terms:

Nervous System Diseases
Physiological Effects of Drugs
Lidocaine
Low Back Pain
Anesthetics
Central Nervous System Depressants
Pain
Cardiovascular Agents
Back Pain
Anesthetics, Local

Pharmacologic Actions
Signs and Symptoms
Sensory System Agents
Therapeutic Uses
Neurologic Manifestations
Bupivacaine
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 09, 2009