Ultrasound Guided Diagnostic Cervical Medial Branch Block

This study has suspended participant recruitment.
(The PI has been unable to continue with the study.)
Sponsor:
Collaborator:
McMaster University
Information provided by (Responsible Party):
McMaster University ( Hamilton Health Sciences Corporation )
ClinicalTrials.gov Identifier:
NCT00896688
First received: April 30, 2009
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

The diagnostic cervical branch block for neck pain due to cervical facet joint pain has been traditionally done under fluoroscopic guidance. Its diagnostic value and technique have been well established. However, recently some studies have shown that the diagnostic cervical and lumbar medial branch block can be done under ultrasound guidance.


Condition Intervention
Facet Joint Pain
Neck Pain
Procedure: cervical medial branch blocks using the Quincke spinal needle

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Ultrasound Guided Diagnostic Cervical Medial Branch Block

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • To determine the efficacy of the use of ultrasound for diagnostic cervical medial branch block on pain patients who have developed neck pain, cervicogenic headache, or shoulder pain. [ Time Frame: At time of procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Interventional pain procedure studies on chronic pain patients [ Time Frame: At time of procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: January 2016
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy Volunteers
It will involve 5 volunteers and they will undergo C arm fluoroscopic guided cervical medial branch blocks (C2-C7) on unilateral position and then followed by the 3D ultrasound machine for visualization of needle position.
Procedure: cervical medial branch blocks using the Quincke spinal needle
#25 gauge 1 and 1/2 inch long needle and #25 gauge 10cm long Quincke spinal needle will be used for placement.
Candidates for upper and lower cervial medical branch blocks
This will involve 25 patients and they will follow the same procedures as the healthy volunteers.
Procedure: cervical medial branch blocks using the Quincke spinal needle
#25 gauge 1 and 1/2 inch long needle and #25 gauge 10cm long Quincke spinal needle will be used for placement.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

Criteria

Inclusion Criteria:

  • healthy volunteers
  • patients who have headache, neck pain, and shoulder pain due to possible facet joint disease

Exclusion Criteria:

  • patients/volunteers with BMI > 35
  • patients/volunteers with short thick neck
  • coagulopathy
  • allergy to local anesthetic, ultrasound gel
  • patient unable to fill out post procedure pain diary
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00896688

Locations
Canada, Ontario
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8N 3Z5
Sponsors and Collaborators
Hamilton Health Sciences Corporation
McMaster University
Investigators
Principal Investigator: Joseph Park, MD Hamilton Health Sciences Corporation
  More Information

Publications:
Responsible Party: McMaster University ( Hamilton Health Sciences Corporation )
ClinicalTrials.gov Identifier: NCT00896688     History of Changes
Other Study ID Numbers: 08-575-D
Study First Received: April 30, 2009
Last Updated: August 20, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
cervical branch block
fluoroscopic guidance
ultrasound guidance

Additional relevant MeSH terms:
Arthralgia
Neck Pain
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms
Neurologic Manifestations
Nervous System Diseases

ClinicalTrials.gov processed this record on September 14, 2014