NCT00613340

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 13, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

August 7, 2009

Status Verified

August 1, 2009

Enrollment Period

1.2 years

First QC Date

January 31, 2008

Last Update Submit

August 5, 2009

Conditions

Keywords

Cervical painZygapophysial jointSpecificity

Outcome Measures

Primary Outcomes (1)

  • Accuracy of injections

    Immediately after nerve blocks.

Secondary Outcomes (1)

  • Pain relief after nerve blocks

    8 hours after blocks

Study Arms (2)

1

EXPERIMENTAL

Cervical medial branch blocks with 0.25 ml of injectate

Procedure: Cervical medial branch blocks

2

EXPERIMENTAL

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

Procedure: Cervical medial branch blocks

Interventions

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

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

Location

Related Publications (3)

  • 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.

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Steven P Cohen, MD

    Walter Reed Army Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 31, 2008

First Posted

February 13, 2008

Study Start

January 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

August 7, 2009

Record last verified: 2009-08

Locations