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

NCT ID: NCT02750436

Last Updated: 2017-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-25

Study Completion Date

2016-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ultrasound guided

Ultrasound guided sacral lateral branch block

Group Type EXPERIMENTAL

Ultrasound guided

Intervention Type DEVICE

This group will be treated using an ultrasound imaging device

Fluoroscopy guided

Fluoroscopically guided sacral lateral branch block

Group Type ACTIVE_COMPARATOR

Fluoroscopy guided

Intervention Type DEVICE

This group will be treated using a fluoroscopy imaging device

Interventions

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Ultrasound guided

This group will be treated using an ultrasound imaging device

Intervention Type DEVICE

Fluoroscopy guided

This group will be treated using a fluoroscopy imaging device

Intervention Type DEVICE

Other Intervention Names

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Ultrasound guided sacral lateral branch block Fluoroscopically guided sacral lateral branch block

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Montreal General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Roderick Finlayson

Professor Department of Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roderick J Finlayson, MD

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Centre/Research Institute of the McGill University Health Centre

Locations

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Montreal General Hospital

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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15-544MUHC

Identifier Type: -

Identifier Source: org_study_id

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