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Fluoroscopically-guided Versus Landmark-guided Sacroiliac Joint Injections

NCT02096653 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2018-02-07

No results posted yet for this study

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

Interventions

PROCEDURE

X-ray SI joint steroid injection

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

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)

Sponsors & Collaborators

  • Uniformed Services University of the Health Sciences

    collaborator FED

  • Walter Reed National Military Medical Center

    collaborator FED

  • Milton S. Hershey Medical Center

    collaborator OTHER

  • United States Naval Medical Center, San Diego

    collaborator FED

  • Johns Hopkins University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02096653 on ClinicalTrials.gov