The Specificity of Cervical Facet Medial Branch Blocks

This study has been completed.

Sponsor:

Collaborator:

Army Regional Anesthesia and Pain Management Initiative

Information provided by:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT00613340

First received: January 31, 2008

Last updated: August 5, 2009

Last verified: August 2009

History of Changes

Purpose

Cervical facet arthropathy is a common cause of chronic neck pain. The "gold standard" for diagnosis is either blocking the facet joints, or more commonly blocking the medial branch nerves that innervate the joints. However, many studies have found a high false-positive rate when the nerves are blocked using 0.5 ml of local anesthetic. We will randomize patients to receive either cervical facet medial branch blocks with 0.25 ml of local anesthetic and contrast, or 0.5 ml. We will then do a CT scan to determine the accuracy and specificity of each block. Our hypothesis is that using the higher volume (0.5 ml) might be responsible for the high false-positive rate.

Condition	Intervention
Neck Pain Cervical Facet Arthropathy	Procedure: Cervical medial branch blocks

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Randomized Study Comparing the Accuracy and Specificity of Cervical Facet Medial Branch Blocks With 0.25 ml and 0.5 ml of Local Anesthetic

Resource links provided by NLM:

MedlinePlus related topics: Joint Disorders Neck Injuries and Disorders

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

Accuracy of injections [ Time Frame: Immediately after nerve blocks. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pain relief after nerve blocks [ Time Frame: 8 hours after blocks ] [ Designated as safety issue: No ]

Enrollment:	20
Study Start Date:	January 2008
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Cervical medial branch blocks with 0.25 ml of injectate	Procedure: Cervical medial branch blocks Cervical medial branch blocks done with 0.25 ml of local anesthetic and contrast
Experimental: 2 Cervical medial branch blocks with 0.5 ml of local anesthetic and contrast	Procedure: Cervical medial branch blocks Cervical medial branch blocks with 0.5 ml of local anesthetic and contrast

Detailed Description:

Inclusion criteria: Dept. of Defense beneficiaries > 18 years of age; neck pain > 3 months duration; cervical paraspinal tenderness Exclusion criteria: Radicular signs or symptoms; use of anticoagulants or bleeding disorder.

Outcome measures: The number of blocks whereby the contrast bathes the target nerve; the number of blocks whereby the contrast spreads to the medial branch nerve at the adjacent spinal level; the number of times the contrast diffuses into the intervertebral foramen or epidural space. We will also compare pain relief over 8 hours following the block between both volumes.

Eligibility

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

Criteria

Inclusion Criteria:

Age > 18 years
Chronic neck pain > 3 months
Paraspinal tenderness

Exclusion Criteria:

Absence of radicular symptoms
No bleeding diathesis
Contrast allergy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00613340

Locations

United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307

Sponsors and Collaborators

Johns Hopkins University

Army Regional Anesthesia and Pain Management Initiative

Investigators

Principal Investigator:

Steven P Cohen, MD

Walter Reed Army Medical Center

More Information

Publications:

Dreyfuss P, Schwarzer AC, Lau P, Bogduk N. Specificity of lumbar medial branch and L5 dorsal ramus blocks. A computed tomography study. Spine. 1997 Apr 15;22(8):895-902.

Lord SM, Barnsley L, Bogduk N. The utility of comparative local anesthetic blocks versus placebo-controlled blocks for the diagnosis of cervical zygapophysial joint pain. Clin J Pain. 1995 Sep;11(3):208-13.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Cohen SP, Strassels SA, Kurihara C, Forsythe A, Buckenmaier CC 3rd, McLean B, Riedy G, Seltzer S. Randomized study assessing the accuracy of cervical facet joint nerve (medial branch) blocks using different injectate volumes. Anesthesiology. 2010 Jan;112(1):144-52.

Responsible Party:	Walter Reed Dept. of Clinical Investigation, Marty Green
ClinicalTrials.gov Identifier:	NCT00613340 History of Changes
Other Study ID Numbers:	NA-20008-A
Study First Received:	January 31, 2008
Last Updated:	August 5, 2009
Health Authority:	United States: Federal Government

Keywords provided by Johns Hopkins University:

Cervical pain
Zygapophysial joint
Specificity

Additional relevant MeSH terms:

Neck Pain
Joint Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Musculoskeletal Diseases
Anesthetics, Local

Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013

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