Fluoroscopically-guided Versus Landmark-guided Sacroiliac Joint Injections

NCT02096653 | Completed

• 1 other identifier: NA_00092414
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Sacroiliac Joint Pain

Keywords

sacroiliac joint; low back pain; steroid injection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Outcomes Related to Disability Measured at 1 Month Using the Oswestry Disability Index

  1 month after the start of treatment

• Worst Back Pain at 1 Month Measured Using the Numeric Pain Scale

  1 month from the start of treatment

• Average Back Pain at 3 Months Measured Using the Numeric Pain Scale

  3 months from the start of treatment

• Worst Back Pain at 3 Months Measured Using the Numeric Pain Scale

  3 months after the start of treatment

• Outcomes Related to Disability Measured at 3 Month Using the Oswestry Disability Index

  3 months after the start of treatment

Study Arms (2)

X-ray guided intra-articular injection

EXPERIMENTAL

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

Landmark-guided SI joint injection

ACTIVE COMPARATOR

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

Interventions

X-ray SI joint steroid injection PROCEDURE

Injection of steroid and local anesthetic into the joint cavity using fluoroscopic guidance

X-ray guided intra-articular injection

Landmark-guided SI steroid injection PROCEDURE

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)

Landmark-guided SI joint injection

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (4)

Naval Hospital-San Diego

San Diego, California, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

Walter Reed National Military Medical Center

Rockville, Maryland, 20889, United States

Location

Penn State

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (2)

• 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.

  PMID: 23253394 BACKGROUND

• 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.

  PMID: 30853260 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2014
• First Posted: March 26, 2014
• Study Start: May 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: February 7, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)