Ultrasound Guided Diagnostic Lumbar Medial Branch Blocks

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by McMaster University
Sponsor:
Collaborator:
McMaster University
Information provided by (Responsible Party):
McMaster University ( Hamilton Health Sciences Corporation )
ClinicalTrials.gov Identifier:
NCT00909272
First received: May 22, 2009
Last updated: February 21, 2014
Last verified: February 2014
  Purpose

Can an ultrasound machine be used to perform a diagnostic lumbar medial branch block?


Condition Intervention
Back Pain
Procedure: Lumbar medial branch block
Procedure: Ultrasound landmarks

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Ultrasound Guided Diagnostic Lumbar Medial Branch Blocks

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Perform a diagnostic lumbar medial branch block using ultrasound guidance, decide if it's practical to perform it, whether patients can tolerate it, can it be performed in a timely manner and the # of needle adjustments required to get target points. [ Time Frame: At time of procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Does this procedure correlate with other known procedures, by the distance between the needle tip placed under the ultrasound and the superior medial aspect of transverse process of lumbar spine L3 to S1 visualized under C-arm fluoroscopy. [ Time Frame: At time of procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: June 2014
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
US-guided lumbar medial branch block
Patients who have low back pain and/or leg pain due to possible lumbar facet joint disease .
Procedure: Lumbar medial branch block
The ultrasound probe will be placed perpendicular to skin along the midline of lumbar spinous process on longitudinal view first to count the lumbar level. The midpoint of each lumbar level will be marked on the longitudinal view and then will be rotated ninety degrees counter clockwise to axial view to locate the facet joint and the transverse process of lumbar spine. A #22 gauge 10cm long Quincke spinal needle will be inserted to the target area using in plane approach on the axial view. Then the probe will be rotated ninety degrees clockwise to longitudinal view to ensure needle tip is placed on the cephalad aspect of the transverse process. It will then be immediately confirmed by C-arm fluoroscopy on oblique view.
Cadavers for Ultrasound landmarks
Cadavers donated to the Department of Anatomy in McMaster University will be used to determine the landmarks for ultrasound.
Procedure: Ultrasound landmarks
The target point is the superior medial aspect of transverse process of lumbar spine from L3 to S1. A #22 gauge 10cm long Quincke spinal needle will be use for needle placement. Needle placement will be visualized with ultrasound. Practice on cadavers with 3 different operators and see if results are reproducible. Verify with fluoroscopy.

Detailed Description:

The diagnostic lumbar medial branch block for low back and radiating to lower extremity due to lumbar facet joint pain has been traditionally done under fluoroscopic guidance. Some recent studies have shown that the diagnostic lumbar medial branch may alternatively be done under ultrasound guidance. This proposed technique has many advantages, avoid radiation exposure and decrease waiting period for patients to have a pain procedure for low back pain. The time taken, patients' satisfaction score, pain score, the distance the needle tip placed under ultrasound and the ideal position visualized under fluoroscopy will be measured. This study will be done in 2 parts. The first part will determine landmarks for ultrasound. It will involve using 5 cadavers. The second part of the study will involve 25 patients. The needles will be placed initially with ultrasound and then will be verified with C-arm fluoroscopy. Certain criteria will be used to determine its feasibility, for example, less than 20 minutes, less than 5 mm.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care pain clinic

Criteria

Inclusion Criteria:

  • Low back and/or leg pain due to possible lumbar facet joint disease

Exclusion Criteria:

  • patient with BMI>35
  • coagulopathy
  • allergy to local anesthetic and 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: NCT00909272

Contacts
Contact: Joseph Park, MD 905-521-8607 josephpark@sympatico.ca
Contact: Mehran Midia, MD 905-521-2100 ext 75296 mmidia@cogeco.ca

Locations
Canada, Ontario
Hamilton Health Sciences Not yet recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Joseph Park, MD    905-525-8607    josephpark@sympatico.ca   
Contact: Mehran Midia, MD    905-521-2100 ext 75296    mmidia@cogeco.ca   
Sub-Investigator: Mehran Midia, MD         
Sub-Investigator: Lehana Thebane, PhD         
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: NCT00909272     History of Changes
Other Study ID Numbers: 09-039-D
Study First Received: May 22, 2009
Last Updated: February 21, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
ultrasound
diagnostic
lumbar
median branch
block
Lumbar facet joint pain

ClinicalTrials.gov processed this record on September 22, 2014