Comparing the Effects of Ultrasound Versus Fluoroscopy for Sacroiliac Joint Injections

Naval Medical Center

Status: Completed

Conditions: Sacroiliitis

Treatments: Device: Havel's Inc. EchoStim (facet tip) 21 Gauge 4" needle; Drug: triamcinolone/lidocaine; Procedure: Ultrasound Guided Sacroiliac Joint Injection; Device: SonoSite S-nerve; Device: iohexol; Procedure: Active comparator: Fluoroscopic Guided SIJ injection

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02420041

NMCSD.2012.0112

Details and patient eligibility

About

The purpose of this research project is to compare two different techniques for performing an injection of the sacroiliac joint. Although both techniques are safe and accurate, the goal of the study is to determine if one technique is better than the other with respect to improvement in a patient's pain, function, and his or her satisfaction. Additionally, the investigators want to determine if one technique is quicker and more efficient than the other.

Full description

Sacroiliac joint dysfunction is a source of low back pain that causes significant pain and disability. Injection of the sacroiliac joint with a local anesthetic/corticosteroid mixture has shown efficacy in treating this condition, when conservative therapy fails. The use of fluoroscopic guidance and anatomic landmarks are traditional methods for performing this injection; however, ultrasound imaging has recently been utilized for performing this procedure. Although studies exist that describe and validate the ultrasound technique, no studies exist that compare the techniques with respect to short-term and long-term outcomes. In this study, the primary objective is to determine if a difference exists between a fluoroscopic-guided technique and ultrasound-guided technique with respect to pain and function. A secondary objective is to compare the two techniques with respect to procedural characteristics.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of SIJ dysfunction by history and physical exam

   • History: Either low back pain or buttock pain
   • Exam: Either tenderness to palpation over the SIJ or a positive provocative maneuver (i.e., Patrick's, Gaenslen's, and/or Yeoman's test)

2. Failed a trial of conservative therapy which may included medications, physical therapy, or both

3. Age > 18

4. Patient agrees to participate in study

Exclusion criteria

1. Coagulopathy
2. Renal or Hepatic Failure
3. Current Pregnancy or actively pursuing pregnancy
4. Known allergy to local anesthetic or steroids
5. Infection at site of needle placement or SIJ infection
6. Patient unable to consent himself or herself
7. Patient refusal
8. Prior surgical procedures involving the SIJ
9. Body Mass Index > 35 kg/m2

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Fluoroscopic Guidance

Active Comparator group

Description:

Patients referred to the Naval Medical Center-San Diego Pain Medicine Clinic. Need a history and physical showing objective findings of sacroiliac joint (SIJ) dysfunction. If the patient meets inclusion / exclusion criteria, they will be presented with the study. After accepting and being consented, they will then be scheduled. The day of the appointment they will be randomised to Group A or B. In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint. Then complete the multidimensional pain inventory (MPI) and rate their pain on the NRS from 0-11. After procedure, they will rate their pain from 0-10 in the recovery area and then be discharged to home. They will complete an MPI, Patient Global Impression of Change (PGIC), numerical rating scale (NRS), and adverse events questionnaire 1-2 weeks post-procedure and 3 months post-procedure.

Treatment:

Device: iohexol

Drug: triamcinolone/lidocaine

Device: Havel's Inc. EchoStim (facet tip) 21 Gauge 4" needle

Procedure: Active comparator: Fluoroscopic Guided SIJ injection

Ultrasound Guidance

Experimental group

Description:

Patients referred to the Naval Medical Center-San Diego Pain Medicine Clinic. Need a history and physical showing objective findings of SIJ dysfunction. If the patient meets inclusion / exclusion criteria, they will be presented with the study. After accepting and being consented, they will then be scheduled. The day of the appointment they will be randomised to Group A or B. In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint. Then complete the MPI and rate their pain on the NRS from 0-11. After procedure, they will rate their pain from 0-10 in the recovery area and then be discharged to home. They will complete an MPI, Patient Global Impression of Change (PIGC), NRS, and adverse events questionnaire 1-2 weeks post-procedure and 3 months post-procedure.

Treatment:

Drug: triamcinolone/lidocaine

Device: Havel's Inc. EchoStim (facet tip) 21 Gauge 4" needle

Device: SonoSite S-nerve

Procedure: Ultrasound Guided Sacroiliac Joint Injection