The Specificity of Cervical Facet Medial Branch Blocks

NCT ID: NCT00613340

Last Updated: 2009-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-04-30

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.

Conditions

Neck Pain; Cervical Facet Arthropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Cervical medial branch blocks with 0.25 ml of injectate

Group Type: EXPERIMENTAL

Cervical medial branch blocks

Intervention Type: PROCEDURE

Cervical medial branch blocks done with 0.25 ml of local anesthetic and contrast

2

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

Group Type: EXPERIMENTAL

Cervical medial branch blocks

Intervention Type: PROCEDURE

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

Interventions

Cervical medial branch blocks

Cervical medial branch blocks done with 0.25 ml of local anesthetic and contrast

Intervention Type: PROCEDURE

Cervical medial branch blocks

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Army Regional Anesthesia and Pain Management Initiative

FED

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Marty Green

Principal Investigators

Steven P Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

Walter Reed Army Medical Center

Locations

Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 9127924 (View on PubMed)

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.

Reference Type: RESULT

PMID: 8535040 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 19996954 (View on PubMed)

Other Identifiers

NA-20008-A

Identifier Type: -

Identifier Source: org_study_id