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

NCT00484159 | Completed Results DMC

• 1 other identifier: NA_00007158
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Low back pain of suspected lumbar zygapophysial etiology

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Successful Treatment

  3-months postprocedure

Study Arms (3)

1

EXPERIMENTAL

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

Procedure: Radiofrequency denervation of medial branches; Drug: 0.5% bupivacaine; Drug: 2% lidocaine; Procedure: Radiofrequency denervation

2

EXPERIMENTAL

Radiofrequency lumbar facet joint denervation if positive response to single facet joint block.

Procedure: Radiofrequency denervation of medial branches; Drug: 0.5% bupivacaine; Procedure: Radiofrequency denervation

3

EXPERIMENTAL

Radiofrequency lumbar facet denervation without a diagnostic facet block.

Procedure: Radiofrequency denervation of medial branches; Procedure: Radiofrequency denervation

Interventions

Radiofrequency denervation of medial branches PROCEDURE

Radiofrequency of medial branches that innervate the lumbar facet joints

1; 2; 3

0.5% bupivacaine DRUG

Diagnostic medial branch block with 0.5% bupivacaine. Blocking the nerves that innervate the facet joints with a long-acting local anesthetic.

1; 2

2% lidocaine DRUG

Diagnostic medial branch block with 2% lidocaine. Blocking the nerves that innervate the facet joints with a short-acting local anesthetic.

1

Radiofrequency denervation PROCEDURE

Radiofrequency lumbar facet denervation without a diagnostic block

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Axial low back pain unresponsive to conservative treatment measures such as physical therapy, manual therapy and pharmacotherapy
• Duration of pain greater than 6 months

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (2)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Bupivacaine; Lidocaine

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides

Limitations and Caveats

This study only followed patients for 3 months, so we don't know if proceeding straight to radiofrequency is associated with the same duration of pain relief as when diagnostic facet blocks are performed.

Results Point of Contact

• Title: Steven P. Cohen
• Organization: Johns Hopkins

scohen40@jhmi.edu

410-955-1822

Study Officials

• Steven P Cohen, MD

  Johns Hopkins School of Medicine, Walter Reed Army Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 6, 2007
• First Posted: June 8, 2007
• Study Start: February 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: July 26, 2011
• Results First Posted: July 21, 2011

Record last verified: 2009-01

Locations

US (2)