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Sacroiliac Joint Injection: Comparison of Xray Versus Ultrasound

Primary Purpose

Sacroiliac Joint Arthritis Causing Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sacroiliac Joint Injection
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sacroiliac Joint Arthritis Causing Low Back Pain focused on measuring Sacroiliac Joint, Ultrasound, Fluoroscopy, Chronic Pain

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Suspicion of SIJ disease on history: pain below the lumbo-sacral junction; pain with full weight-bearing on one leg; pain worse going down hills or inclines; very low back pain associated with groin pain and absence of lumbar symptoms
  • Two positive responses to the following maneuver: FABER (flexion abduction and external rotation of hip), POSH (posterior shear test), REAB (resisted abduction)
  • Baseline NRS pain score > or = to 4
  • Refractory to oral analgesic therapy

Exclusion Criteria:

  • ongoing litigation issues related to the patient's pain
  • pregnancy
  • allergy to steroids or local anesthetics
  • multiple comorbidities
  • BMI > 35

Sites / Locations

  • Toronto Western Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ultrasound Guided SIJ Injection

Xray Guided SIJ Injection

Arm Description

Needle placement will be performed under US guidance. Fluoroscopy will be used to confirm needle placement prior to medication injection.

Needle placement will be performed under fluoroscopy.

Outcomes

Primary Outcome Measures

Incidence of needle placement into SIJ
Pain - Numeric Rating Scale Score at 1 month

Secondary Outcome Measures

Improvement of functional ability at 1 month
Oswestry Disability Index completed at 1 month to determine level of disability
Patient Satisfaction
Average daily consumption of opioids at 1 month
Patient discomfort with procedure
Number of needle readjustments

Full Information

First Posted
October 29, 2012
Last Updated
December 21, 2016
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01719081
Brief Title
Sacroiliac Joint Injection: Comparison of Xray Versus Ultrasound
Official Title
Ultrasound for Sacroiliac Joint Injection: Evaluation of the Efficacy of Two Image-Guided Techniques for Sacroiliac Joint Injection
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This project involves the assessment of the efficacy of two different image guided techniques in patients with low back pain due to arthritis of the sacroiliac joint (SIJ). Intra-articular injection of local anesthetics and steroids is performed to relieve pain originating from the SIJ. Fluoroscopy has been used traditionally for image guidance for this procedure but there is a growing interest in use of ultrasound (US) for this procedure. US avoids radiation exposure to the patient and the health care team (HCT) and is less expensive. We aim to compare procedural efficacy related outcomes for SIJ injections performed using these image-guided modalities.
Detailed Description
The study is a prospective, randomized trial. Patients with low back pain which is diagnosed secondary to SIJ disease will be identified beforehand in clinic and offered a therapeutic joint injection. Informed consent will be obtained. Patients will be randomized for SIJ block with 3 mL of 0.25% bupivacaine with 1:200,000 epinephrine and 40 mg depomedrol using guidance with ultrasound or fluoroscopy. In both groups, confirmation of needle placement will be obtained using contrast injection imaging before the injection is performed. Record will be made of the number of times the needle is correctly placed into the articular space, as well as the number of attempts to do so. The final position of the needle will be recorded. Pain scores will be assessed before the procedure, as well as post-procedure at 24 and 72 hours, as well as 1 week, 1 month, and 3 months. Patients will keep a pain diary and will be followed up at 3 months time in clinic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sacroiliac Joint Arthritis Causing Low Back Pain
Keywords
Sacroiliac Joint, Ultrasound, Fluoroscopy, Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound Guided SIJ Injection
Arm Type
Experimental
Arm Description
Needle placement will be performed under US guidance. Fluoroscopy will be used to confirm needle placement prior to medication injection.
Arm Title
Xray Guided SIJ Injection
Arm Type
Active Comparator
Arm Description
Needle placement will be performed under fluoroscopy.
Intervention Type
Procedure
Intervention Name(s)
Sacroiliac Joint Injection
Intervention Description
Medication injected into the sacroiliac joint: Bupivicaine 3ml 0.25% with epinephrine 1/200,000 and Depo-Medrol 40mg.
Primary Outcome Measure Information:
Title
Incidence of needle placement into SIJ
Time Frame
Assessed at time of injection
Title
Pain - Numeric Rating Scale Score at 1 month
Time Frame
One month from time of injection
Secondary Outcome Measure Information:
Title
Improvement of functional ability at 1 month
Description
Oswestry Disability Index completed at 1 month to determine level of disability
Time Frame
1 month from time of injection
Title
Patient Satisfaction
Time Frame
1 month from time of injection
Title
Average daily consumption of opioids at 1 month
Time Frame
1 month from injection
Title
Patient discomfort with procedure
Time Frame
Measured at time of procedure
Title
Number of needle readjustments
Time Frame
Measured at time of procedure
Other Pre-specified Outcome Measures:
Title
Assessment of complications
Description
Complications assessed at any point until 3 months after procedure
Time Frame
Until 3 months after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Suspicion of SIJ disease on history: pain below the lumbo-sacral junction; pain with full weight-bearing on one leg; pain worse going down hills or inclines; very low back pain associated with groin pain and absence of lumbar symptoms Two positive responses to the following maneuver: FABER (flexion abduction and external rotation of hip), POSH (posterior shear test), REAB (resisted abduction) Baseline NRS pain score > or = to 4 Refractory to oral analgesic therapy Exclusion Criteria: ongoing litigation issues related to the patient's pain pregnancy allergy to steroids or local anesthetics multiple comorbidities BMI > 35
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anuj Bhatia, MD, FRCPC
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada

12. IPD Sharing Statement

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Sacroiliac Joint Injection: Comparison of Xray Versus Ultrasound

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