The Specificity of Cervical Facet Medial Branch Blocks

Neck Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00613340
• Other study ID #: NA-20008-A
• Status: Completed
• Phase: N/A
• First received: January 31, 2008
• Last updated: August 5, 2009
• Start date: January 2008
• Est. completion date: April 2009

Study information

• Verified date: August 2009
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• Chronic neck pain > 3 months

• Paraspinal tenderness

Exclusion Criteria:

• Absence of radicular symptoms

• No bleeding diathesis

• Contrast allergy

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Facet Arthropathy
• Neck Pain

Intervention

Procedure:
• Cervical medial branch blocks
Cervical medial branch blocks done with 0.25 ml of local anesthetic and contrast
• Cervical medial branch blocks
Cervical medial branch blocks with 0.5 ml of local anesthetic and contrast

Locations

Country	Name	City	State
United States	Walter Reed Army Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Army Regional Anesthesia and Pain Management Initiative

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of injections		Immediately after nerve blocks.	No
Secondary	Pain relief after nerve blocks		8 hours after blocks	No