Clinical trial NCT00909272: Ultrasound Guided Diagnostic Lumbar Medial Branch Blocks
Official title: Ultrasound Guided Diagnostic Lumbar Medial Branch Blocks
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Back Pain
Keywords: ultrasound
diagnostic
lumbar
median branch
block
Lumbar facet joint pain
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: McMaster University
First posted: 2009-05-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care pain clinic

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

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 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

Primary outcomes:
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.
timeFrame: At time of procedure
Secondary outcomes:
measure: 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.
timeFrame: At time of procedure
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences-General Location
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Joseph Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/j.rapm.2006.06.246.