Ultrasound Guided Diagnostic Lumbar Medial Branch Blocks

Withdrawn

• Conditions: Back Pain
• Interventions: Procedure: Ultrasound landmarks; Procedure: Lumbar medial branch block

• Registration Number: NCT00909272
• Lead Sponsor: Hamilton Health Sciences Corporation

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.

Study Timeline

• Study First Submitted: 2009-05-22
• Study First Submitted QC: 2009-05-22
• Study First Posted: 2009-05-27
• Study Start: 2014-07
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cadavers for Ultrasound landmarks	Ultrasound landmarks	Cadavers donated to the Department of Anatomy in McMaster University will be used to determine the landmarks for ultrasound.
US-guided lumbar medial branch block	Lumbar medial branch block	Patients who have low back pain and/or leg pain due to possible lumbar facet joint disease .

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hamilton Health Sciences-General Location; 🇨🇦 Hamilton, Ontario, Canada