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
  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:


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
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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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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:
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014