Comparing the Effects of Ultrasound Versus Fluoroscopy for Sacroiliac Joint Injections

NCT ID: NCT02420041

Last Updated: 2015-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-03-31

Brief Summary

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.

Detailed 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.

Conditions

Sacroiliitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fluoroscopic Guidance

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.

Group Type: ACTIVE_COMPARATOR

Active comparator: Fluoroscopic Guided SIJ injection

Intervention Type: PROCEDURE

• Needle entry point is in the lower one-third of the SIJ
• Sterile preparation (with chlorhexidine) and draping and 3 mL of 1% lidocaine injected subcutaneously at site of needle entry
• Under fluoroscopy guidance, Havel's Inc. EchoStim (facet tip) 21 Gauge 4" needle is inserted in a coaxial fashion into the SIJ
• 1 mL of contrast (iohexol 300 mg/mL) is injected to outline the SIJ and to ensure no vascular uptake
• Injection of 20 mg of triamcinolone diluted in 4 mL of 1% lidocaine
• Patient observed in recovery bay for 20 minutes and then discharged home

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

Intervention Type: DEVICE

iohexol

Intervention Type: DEVICE

triamcinolone/lidocaine

Intervention Type: DRUG

Ultrasound Guidance

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.

Group Type: EXPERIMENTAL

Ultrasound Guided Sacroiliac Joint Injection

Intervention Type: PROCEDURE

• Sterile preparation (with chlorhexidine) and drape
• Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer
• 3 mL of 1% lidocaine is injected subcutaneously at site of needle entry
• Under ultrasound guidance, a Havel's Inc. EchoStim (facet tip) 21 Gauge 4" needle is inserted in a medial to lateral direction and guided into the SIJ. (0.5-2 mL of normal saline may be injected during needle insertion to locate tip of needle and to ensure solution does not "spill out" onto sacrum).
• After using the Doppler function to identify any surrounding vessels (to avoid intravascular injection), 20 mg of triamcinolone diluted in 4 mL of 1% lidocaine is injected.
• Patient observed in recovery bay for 20 minutes and then discharged home

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

Intervention Type: DEVICE

SonoSite S-nerve

Intervention Type: DEVICE

triamcinolone/lidocaine

Intervention Type: DRUG

Interventions

Active comparator: Fluoroscopic Guided SIJ injection

• Needle entry point is in the lower one-third of the SIJ
• Sterile preparation (with chlorhexidine) and draping and 3 mL of 1% lidocaine injected subcutaneously at site of needle entry
• Under fluoroscopy guidance, Havel's Inc. EchoStim (facet tip) 21 Gauge 4" needle is inserted in a coaxial fashion into the SIJ
• 1 mL of contrast (iohexol 300 mg/mL) is injected to outline the SIJ and to ensure no vascular uptake
• Injection of 20 mg of triamcinolone diluted in 4 mL of 1% lidocaine
• Patient observed in recovery bay for 20 minutes and then discharged home

Intervention Type: PROCEDURE

Ultrasound Guided Sacroiliac Joint Injection

• Sterile preparation (with chlorhexidine) and drape
• Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer
• 3 mL of 1% lidocaine is injected subcutaneously at site of needle entry
• Under ultrasound guidance, a Havel's Inc. EchoStim (facet tip) 21 Gauge 4" needle is inserted in a medial to lateral direction and guided into the SIJ. (0.5-2 mL of normal saline may be injected during needle insertion to locate tip of needle and to ensure solution does not "spill out" onto sacrum).
• After using the Doppler function to identify any surrounding vessels (to avoid intravascular injection), 20 mg of triamcinolone diluted in 4 mL of 1% lidocaine is injected.
• Patient observed in recovery bay for 20 minutes and then discharged home

Intervention Type: PROCEDURE

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

Intervention Type: DEVICE

SonoSite S-nerve

Intervention Type: DEVICE

iohexol

Intervention Type: DEVICE

triamcinolone/lidocaine

Intervention Type: DRUG

Eligibility Criteria

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

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

Sponsors

United States Naval Medical Center, Portsmouth

FED

Sponsor Role: collaborator

United States Naval Medical Center, San Diego

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven R Hanling, MD

Role: PRINCIPAL_INVESTIGATOR

United States Naval Medical Center, San Diego

Locations

Pain Medicine Center, Department of Anesthesiology, Naval Medical Center, San Diego

San Diego, California, United States

Countries

United States

Other Identifiers

NMCSD.2012.0112

Identifier Type: -

Identifier Source: org_study_id