- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00613340
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20307
- Walter Reed Army Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age > 18 years
- Chronic neck pain > 3 months
- Paraspinal tenderness
Exclusion Criteria:
- Absence of radicular symptoms
- No bleeding diathesis
- Contrast allergy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Cervical medial branch blocks with 0.25 ml of injectate
|
Cervical medial branch blocks done with 0.25 ml of local anesthetic and contrast
Cervical medial branch blocks with 0.5 ml of local anesthetic and contrast
|
Experimental: 2
Cervical medial branch blocks with 0.5 ml of local anesthetic and contrast
|
Cervical medial branch blocks done with 0.25 ml of local anesthetic and contrast
Cervical medial branch blocks with 0.5 ml of local anesthetic and contrast
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Accuracy of injections
Time Frame: Immediately after nerve blocks.
|
Immediately after nerve blocks.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain relief after nerve blocks
Time Frame: 8 hours after blocks
|
8 hours after blocks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Steven P Cohen, MD, Walter Reed Army Medical Center
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA-20008-A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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