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The Specificity of Cervical Facet Medial Branch Blocks

Primary Purpose

Neck Pain, Cervical Facet Arthropathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cervical medial branch blocks
Cervical medial branch blocks
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Cervical pain, Zygapophysial joint, Specificity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Absence of radicular symptoms
  • No bleeding diathesis
  • Contrast allergy

Sites / Locations

  • Walter Reed Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Cervical medial branch blocks with 0.25 ml of injectate

Cervical medial branch blocks with 0.5 ml of local anesthetic and contrast

Outcomes

Primary Outcome Measures

Accuracy of injections

Secondary Outcome Measures

Pain relief after nerve blocks

Full Information

First Posted
January 31, 2008
Last Updated
August 5, 2009
Sponsor
Johns Hopkins University
Collaborators
Army Regional Anesthesia and Pain Management Initiative
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1. Study Identification

Unique Protocol Identification Number
NCT00613340
Brief Title
The Specificity of Cervical Facet Medial Branch Blocks
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Johns Hopkins University
Collaborators
Army Regional Anesthesia and Pain Management Initiative

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Cervical Facet Arthropathy
Keywords
Cervical pain, Zygapophysial joint, Specificity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Cervical medial branch blocks with 0.25 ml of injectate
Arm Title
2
Arm Type
Experimental
Arm Description
Cervical medial branch blocks with 0.5 ml of local anesthetic and contrast
Intervention Type
Procedure
Intervention Name(s)
Cervical medial branch blocks
Intervention Description
Cervical medial branch blocks done with 0.25 ml of local anesthetic and contrast
Intervention Type
Procedure
Intervention Name(s)
Cervical medial branch blocks
Intervention Description
Cervical medial branch blocks with 0.5 ml of local anesthetic and contrast
Primary Outcome Measure Information:
Title
Accuracy of injections
Time Frame
Immediately after nerve blocks.
Secondary Outcome Measure Information:
Title
Pain relief after nerve blocks
Time Frame
8 hours after blocks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 years Chronic neck pain > 3 months Paraspinal tenderness Exclusion Criteria: Absence of radicular symptoms No bleeding diathesis Contrast allergy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven P Cohen, MD
Organizational Affiliation
Walter Reed Army Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9127924
Citation
Dreyfuss P, Schwarzer AC, Lau P, Bogduk N. Specificity of lumbar medial branch and L5 dorsal ramus blocks. A computed tomography study. Spine (Phila Pa 1976). 1997 Apr 15;22(8):895-902. doi: 10.1097/00007632-199704150-00013.
Results Reference
result
PubMed Identifier
8535040
Citation
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. doi: 10.1097/00002508-199509000-00008.
Results Reference
result
PubMed Identifier
19996954
Citation
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. doi: 10.1097/ALN.0b013e3181c38a82.
Results Reference
derived

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The Specificity of Cervical Facet Medial Branch Blocks

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