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Sponsors and Collaborators: |
Johns Hopkins University Army Regional Anesthesia and Pain Management Initiative |
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Information provided by: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00613340 |
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 |
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Neck Pain Cervical Facet Arthropathy |
Procedure: Cervical medial branch blocks |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Dose Comparison, Parallel Assignment |
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 |
Estimated Enrollment: | 20 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Cervical medial branch blocks with 0.25 ml of injectate
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Procedure: Cervical medial branch blocks
Cervical medial branch blocks done with 0.25 ml of local anesthetic and contrast
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2: Experimental
Cervical medial branch blocks with 0.5 ml of local anesthetic and contrast
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Procedure: Cervical medial branch blocks
Cervical medial branch blocks with 0.5 ml of local anesthetic and contrast
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Connie Kurihara, RN | jerry_kurihara@yahoo.com |
United States, District of Columbia | |
Walter Reed Army Medical Center | Recruiting |
Washington, District of Columbia, United States, 20307 | |
Contact: Connie Kurihara, RN jerry_kurihara@yahoo.com | |
Principal Investigator: Steven P Cohen, MD | |
Sub-Investigator: Scott Griffith, MD | |
Sub-Investigator: Akara Forsythe, MD |
Principal Investigator: | Steven P Cohen, MD | Walter Reed Army Medical Center |
Responsible Party: | Marty Green ( Walter Reed Dept. of Clinical Investigation ) |
Study ID Numbers: | NA-20008-A |
Study First Received: | January 31, 2008 |
Last Updated: | February 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00613340 History of Changes |
Health Authority: | United States: Federal Government |
Cervical pain Zygapophysial joint Specificity |
Signs and Symptoms Joint Diseases Neck Pain Central Nervous System Depressants Anesthetics |
Neurologic Manifestations Pain Peripheral Nervous System Agents Anesthetics, Local |
Neck Pain Nervous System Diseases Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Pain Anesthetics, Local |
Pharmacologic Actions Signs and Symptoms Sensory System Agents Therapeutic Uses Neurologic Manifestations Peripheral Nervous System Agents Central Nervous System Agents |