Fluoroscopically-guided Versus Landmark-guided Sacroiliac Joint Injections

Randomized, Controlled, Double-blind, Comparative-effectiveness Study Comparing Fluoroscopically-guided and Landmark-guided Sacroiliac Joint Injections

In this study, the investigators are attempting to determine whether intra- or extra-articular injections are more effective; the relative prevalence rate of intra-articular and extra-articular SI joint pain; and the accuracy of extra-articular injections using fluoroscopy as the reference standard. 124 consecutive patients with mechanical low back pain below L5, tenderness overlying the SI joint(s) and at least 3 positive provocative maneuvers will be randomized to receive SI joint injections by 2 different approaches.

Group 1 will receive fluoroscopically-guided injections into the joint. Group 2 will receive landmark-guided injections into the tender area around the joint. In order to determine whether the injection in group 2 was intra-articular or extra-articular, an x-ray will be done after the injection to ascertain the location of contrast spread. The primary outcome measure will be pain relief at 1-month. Patients who obtain benefit at 1-month will be followed at 3-months, while those who fail to obtain benefit will exit the study to receive alternative care.

Study Overview

• Status: Completed
• Conditions: Sacroiliac Joint Pain
• Intervention / Treatment: Procedure: X-ray SI joint steroid injection; Procedure: Landmark-guided SI steroid injection

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States
      • Naval Hospital-San Diego
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins Hospital
    • Rockville, Maryland, United States, 20889
      • Walter Reed National Military Medical Center
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age > 18;
2. Low back pain principally below the L5 vertebra;
3. Three out of 6 positive SI joint provocative maneuvers;
4. Agreed to undergo SI joint injection for diagnostic/ therapeutic purposes;
5. Average pain score > 3/10 over the past week;
6. Pain duration > 6 weeks;

Exclusion Criteria:

1. Previous SI joint injection;
2. Leg pain > back pain or lower leg pain > upper leg pain
3. Active inflammatory spondyloarthropathy (e.g. ankylosing spondylitis);
4. Untreated coagulopathy;
5. Allergy to contrast dye or bupivacaine;
6. Pain > 20 years in duration;
7. Poorly controlled psychiatric (e.g. PTSD) or medical (congestive heart failure) condition

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: X-ray guided intra-articular injection; Injection of 40 mg depomethylprednisolone and 2 ml 0.5% bupivacaine into the SI (sacroiliac joint) cavity under fluoroscopic guidance	Procedure: X-ray SI joint steroid injection; Injection of steroid and local anesthetic into the joint cavity using fluoroscopic guidance
Active Comparator: Landmark-guided SI joint injection; Injection of 40 mg depomethylprednisolone and 2 ml 0.5% bupivacaine at the point of maximal tenderness (3 ml)	Procedure: Landmark-guided SI steroid injection; Injection of steroid into the joint area based on palpation. The injection may be inside the joint (intra-articular) or outside the joint in the ligaments (extra-articular)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Back Pain at 1 Month Measured Using the Numeric Pain Scale	This outcome measure compares the average back pain at baseline to the average back pain 1 month after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The group receiving fluoroscopically-guided intra-articular injection is compared to the group receiving landmark-guided injections.	1 month from the start of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Outcomes Related to Disability Measured at 1 Month Using the Oswestry Disability Index	Functional capacity measured using Oswestry disability index. The range of possible scores for Oswestry Disability Index are 0-100. 0 is equated with no disability and 100 is the maximum disability possible.	1 month after the start of treatment
Outcomes Related to Disability Measured at 3 Month Using the Oswestry Disability Index	Functional capacity measured using Oswestry disability index. The range of possible scores for Oswestry Disability Index are 0-100. 0 is equated with no disability and 100 is the maximum disability possible.	3 months after the start of treatment
Worst Back Pain at 1 Month Measured Using the Numeric Pain Scale	This outcome measure compares the worst back pain at baseline to the worst back pain at 1 months after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The group receiving fluoroscopically-guided intra-articular injection is compared to the group receiving landmark-guided injections.	1 month from the start of treatment
Average Back Pain at 3 Months Measured Using the Numeric Pain Scale	This outcome measure compares the average back pain at baseline to the average back pain at 3 months after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The group receiving fluoroscopically-guided intra-articular injection is compared to the group receiving landmark-guided injections.	3 months from the start of treatment
Worst Back Pain at 3 Months Measured Using the Numeric Pain Scale	This outcome measure compares the worst back pain at baseline to the worst back pain at 3 months after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The group receiving fluoroscopically-guided intra-articular injection is compared to the group receiving landmark-guided injections.	3 months after the start of treatment
Patient satisfaction of the procedure at 1 month measured using the Likert Scale	Patient satisfaction is measured at 1 month after the procedure using the Likert Scale. The range of possible scores for the Likert Scale are 1-5. I being very unsatisfied and 5 being very satisfied.	1 month
Patient satisfaction of the procedure at 3 months measured using the Likert Scale	Patient satisfaction is measured at 1 month after the procedure using the Likert Scale. The range of possible scores for the Likert Scale are 1-5. I being very unsatisfied and 5 being very satisfied.	3 months
Positive categorical outcome	Decrease in average back pain score at 1 month of greater or equal to 2 points coupled with a satisfaction score > 3 on a 1-5 scale	1 month
Positive categorical outcome	Decrease in average back pain score at 3 months of greater or equal to 2 points coupled with a satisfaction score > 3 on a 1-5 scale	3 months
Positive diagnostic blocks	The percentage of participants who experience greater or equal to 50% pain relief based on their pain diary	6 hours

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Milton S. Hershey Medical Center; United States Naval Medical Center, San Diego; Walter Reed National Military Medical Center; Uniformed Services University of the Health Sciences

Publications and helpful links

General Publications

• Cohen SP, Chen Y, Neufeld NJ. Sacroiliac joint pain: a comprehensive review of epidemiology, diagnosis and treatment. Expert Rev Neurother. 2013 Jan;13(1):99-116. doi: 10.1586/ern.12.148.
• Cohen SP, Bicket MC, Kurihara C, Griffith SR, Fowler IM, Jacobs MB, Liu R, Anderson White M, Verdun AJ, Hari SB, Fisher RL, Pasquina PF, Vorobeychik Y. Fluoroscopically Guided vs Landmark-Guided Sacroiliac Joint Injections: A Randomized Controlled Study. Mayo Clin Proc. 2019 Apr;94(4):628-642. doi: 10.1016/j.mayocp.2018.08.038. Epub 2019 Mar 8.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: March 22, 2014
• First Submitted That Met QC Criteria: March 25, 2014
• First Posted (Estimate): March 26, 2014

Study Record Updates

• Last Update Posted (Actual): February 7, 2018
• Last Update Submitted That Met QC Criteria: February 5, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: low back pain; steroid injection; sacroiliac joint
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia
• Other Study ID Numbers: NA_00092414

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO