Back to resultsA Comparison of Ultrasound Versus Fluoroscopic Guidance for Sacral Lateral Branch Blocks (USGSLBB)
Primary Purpose
Back Pain
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ultrasound guided
Fluoroscopy guided
Sponsored by
About this trial
This is an interventional treatment trial for Back Pain
Eligibility Criteria
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.
Sites / Locations
- Montreal General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ultrasound guided
Fluoroscopy guided
Arm Description
Ultrasound guided sacral lateral branch block
Fluoroscopically guided sacral lateral branch block
Outcomes
Primary Outcome Measures
Performance time
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.
Secondary Outcome Measures
Change in pain numerical rating score from baseline
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.
Full Information
NCT ID
NCT02750436
First Posted
April 17, 2016
Last Updated
March 24, 2017
Sponsor
Montreal General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02750436
Brief Title
A Comparison of Ultrasound Versus Fluoroscopic Guidance for Sacral Lateral Branch Blocks
Acronym
USGSLBB
Official Title
A Prospective Randomized Comparison of Ultrasound Versus Fluoroscopic Guidance for Sacral Lateral Branch Blocks
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 25, 2016 (Actual)
Primary Completion Date
July 30, 2016 (Actual)
Study Completion Date
July 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montreal General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound guided
Arm Type
Experimental
Arm Description
Ultrasound guided sacral lateral branch block
Arm Title
Fluoroscopy guided
Arm Type
Active Comparator
Arm Description
Fluoroscopically guided sacral lateral branch block
Intervention Type
Device
Intervention Name(s)
Ultrasound guided
Other Intervention Name(s)
Ultrasound guided sacral lateral branch block
Intervention Description
This group will be treated using an ultrasound imaging device
Intervention Type
Device
Intervention Name(s)
Fluoroscopy guided
Other Intervention Name(s)
Fluoroscopically guided sacral lateral branch block
Intervention Description
This group will be treated using a fluoroscopy imaging device
Primary Outcome Measure Information:
Title
Performance time
Description
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.
Time Frame
Duration of procedure (less than 20 minutes)
Secondary Outcome Measure Information:
Title
Change in pain numerical rating score from baseline
Description
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.
Time Frame
Baseline and 20 minutes after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roderick J Finlayson, MD
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G1A4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Comparison of Ultrasound Versus Fluoroscopic Guidance for Sacral Lateral Branch Blocks
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