A Comparison of Ultrasound Versus Fluoroscopic Guidance for Sacral Lateral Branch Blocks (USGSLBB)

March 24, 2017 updated by: Roderick Finlayson, Montreal General Hospital

A Prospective Randomized Comparison of Ultrasound Versus Fluoroscopic Guidance for Sacral Lateral Branch Blocks

Sacral lateral branch blocks are used for the diagnosis and treatment of sacroiliac joint pain. This study will compare ultrasound and fluoroscopy guidance for sacral lateral branch blocks. Outcomes examined will include performance times and success rates.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3G1A4
        • Montreal General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any consenting patient over 18 years of age, undergoing a diagnostic sacral lateral branch block for suspected sacroiliac joint related pain.

Exclusion Criteria:

  • Inability to consent, iodine or lidocaine allergy, pregnancy, coagulopathy (as defined by an international normalized ratio over 1.4, platelets under 100,000, or a documented bleeding disorder) and inability to visualize the target areas necessary for sensory testing (posterior superior iliac spine, dorsal aspect of SIJ) under ultrasound guidance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound guided
Ultrasound guided sacral lateral branch block
Device: Ultrasound guided
This group will be treated using an ultrasound imaging device
Other Names:
  • Ultrasound guided sacral lateral branch block
Active Comparator: Fluoroscopy guided
Fluoroscopically guided sacral lateral branch block
Device: Fluoroscopy guided
This group will be treated using a fluoroscopy imaging device
Other Names:
  • Fluoroscopically guided sacral lateral branch block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance time
Time Frame: Duration of procedure (less than 20 minutes)
Block performance time will be measured from the time the first image is acquired, until the last injection is completed. Typical performance time are expected to be less than 20 minutes for both groups.
Duration of procedure (less than 20 minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain numerical rating score from baseline
Time Frame: Baseline and 20 minutes after procedure
The extent of anesthesia provided by the blocks will be assessed by probing structures known to be innervated by the lateral branches and L5 posterior root. Two pain measurements will be undertaken, before and 20 minutes after the injections. Pain reports will be quantified by using a numerical rating score.
Baseline and 20 minutes after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montreal General Hospital

Investigators

  • Principal Investigator: Roderick J Finlayson, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2016

Primary Completion (Actual)

July 30, 2016

Study Completion (Actual)

July 30, 2016

Study Registration Dates

First Submitted

April 17, 2016

First Submitted That Met QC Criteria

April 20, 2016

First Posted (Estimate)

April 25, 2016

Study Record Updates

Last Update Posted (Actual)

March 27, 2017

Last Update Submitted That Met QC Criteria

March 24, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-544MUHC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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