Ultrasound Guided Diagnostic Lumbar Medial Branch Blocks

NCT00909272 | Withdrawn

• 1 other identifier: 09-039-D
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Back Pain

Keywords

ultrasound; diagnostic; lumbar; median branch; block; Lumbar facet joint pain

Outcome Measures

Primary Outcomes (1)

• 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.

  At time of procedure

Secondary Outcomes (1)

• 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.

  At time of procedure

Study Arms (2)

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

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

Interventions

Lumbar medial branch block PROCEDURE

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.

US-guided lumbar medial branch block

Ultrasound landmarks PROCEDURE

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.

Cadavers for Ultrasound landmarks

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care pain clinic

You may qualify if:

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

You may not qualify if:

• patient with BMI\>35
• coagulopathy
• allergy to local anesthetic and ultrasound gel
• patient unable to fill out post procedure pain diary

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• McMaster University: collaborator

Study Sites (1)

Hamilton Health Sciences-General Location

Hamilton, Ontario, L8N 3Z5, Canada

Location

Related Publications (1)

• 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.

  PMID: 16952818 BACKGROUND

MeSH Terms

Conditions

Back Pain; Disease; Bites and Stings

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Joseph Park, MD

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2009
• First Posted: May 27, 2009
• Study Start: July 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 8, 2015

Record last verified: 2015-04

Locations

CA (1)