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Ultrasound Guided Diagnostic Lumbar Medial Branch Blocks

This study is not yet open for participant recruitment.
Verified July 2011 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: April 23, 2013
Last verified: July 2011
History of Changes

May 22, 2009
April 23, 2013
June 2013
January 2014   (final data collection date for primary outcome measure)
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 ]
To perform a diagnostic lumbar medial branch block using ultrasound guidance and to decide if it is practical to perform the procedure and whether patients can tolerate it. [ Time Frame: At time of procedure ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00909272 on ClinicalTrials.gov Archive Site
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 ]
The length of time to perform the procedure and the number of needle adjustments required to get the target points [ Time Frame: At time of procedure ] [ Designated as safety issue: No ]
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Ultrasound Guided Diagnostic Lumbar Medial Branch Blocks
Ultrasound Guided Diagnostic Lumbar Medial Branch Blocks

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

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.
Observational
Time Perspective: Prospective
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Non-Probability Sample

Primary care pain clinic
Back Pain
  • 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.
  • 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.
  • Ultrasound-guided lumbar medial branch block
    Patients who have low back pain and/or leg pain due to possible lumbar facet joint disease .
    Intervention: Procedure: Lumbar medial branch block
  • Cadavers
    Cadavers donated to the Department of Anatomy in McMaster University will be used to determine the landmarks for ultrasound.
    Intervention: Procedure: Ultrasound landmarks
Shim JK, Moon JC, Yoon KB, Kim WO, Yoon DM. Ultrasound-guided lumbar medial-branch block: a clinical study with fluoroscopy control. Reg Anesth Pain Med. 2006 Sep-Oct;31(5):451-4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
25
April 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Joseph Park, MD 905-521-8607 josephpark@sympatico.ca
Contact: Mehran Midia, MD 905-521-2100 ext 75296 mmidia@cogeco.ca
Canada
 
NCT00909272
09-039-D
No
McMaster University ( Hamilton Health Sciences Corporation )
Hamilton Health Sciences Corporation
McMaster University
Principal Investigator: Joseph Park, MD Hamilton Health Sciences Corporation
McMaster University
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP