Fluoroscopically-guided Versus Landmark-guided Sacroiliac Joint Injections

NCT ID: NCT02096653

Last Updated: 2018-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2017-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

X-ray SI joint steroid injection

Intervention Type: PROCEDURE

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

Landmark-guided SI joint injection

Injection of 40 mg depomethylprednisolone and 2 ml 0.5% bupivacaine at the point of maximal tenderness (3 ml)

Group Type: ACTIVE_COMPARATOR

Landmark-guided SI steroid injection

Intervention Type: 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)

Interventions

X-ray SI joint steroid injection

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

Intervention Type: 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)

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uniformed Services University of the Health Sciences

FED

Sponsor Role: collaborator

Walter Reed National Military Medical Center

FED

Sponsor Role: collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role: collaborator

United States Naval Medical Center, San Diego

FED

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Naval Hospital-San Diego

San Diego, California, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Walter Reed National Military Medical Center

Rockville, Maryland, United States

Penn State

Hershey, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 23253394 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30853260 (View on PubMed)

Other Identifiers

NA_00092414

Identifier Type: -

Identifier Source: org_study_id