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

January 31, 2008
August 5, 2009
January 2008
April 2009   (final data collection date for primary outcome measure)
Accuracy of injections [ Time Frame: Immediately after nerve blocks. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00613340 on ClinicalTrials.gov Archive Site
Pain relief after nerve blocks [ Time Frame: 8 hours after blocks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Specificity of Cervical Facet Medial Branch Blocks
Randomized Study Comparing the Accuracy and Specificity of Cervical Facet Medial Branch Blocks With 0.25 ml and 0.5 ml of Local Anesthetic

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Neck Pain
  • Cervical Facet Arthropathy
  • Procedure: Cervical medial branch blocks
    Cervical medial branch blocks done with 0.25 ml of local anesthetic and contrast
  • Procedure: Cervical medial branch blocks
    Cervical medial branch blocks with 0.5 ml of local anesthetic and contrast
  • Experimental: 1
    Cervical medial branch blocks with 0.25 ml of injectate
    Intervention: Procedure: Cervical medial branch blocks
  • Experimental: 2
    Cervical medial branch blocks with 0.5 ml of local anesthetic and contrast
    Intervention: Procedure: Cervical medial branch blocks

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
April 2009
April 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Absence of radicular symptoms
  • No bleeding diathesis
  • Contrast allergy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00613340
NA-20008-A
No
Walter Reed Dept. of Clinical Investigation, Marty Green
Johns Hopkins University
Army Regional Anesthesia and Pain Management Initiative
Principal Investigator: Steven P Cohen, MD Walter Reed Army Medical Center
Johns Hopkins University
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP