Comparing the Effects of Ultrasound Versus Fluoroscopy for Sacroiliac Joint Injections

Comparison of the Efficacy of Two Techniques for Sacroiliac Joint Injection: Ultrasound Guidance Versus Fluoroscopic Guidance

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.

Study Overview

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

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92134
      • Pain Medicine Center, Department of Anesthesiology, Naval Medical Center, San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Procedure: 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; Device: Havel's Inc. EchoStim (facet tip) 21 Gauge 4" needle; Device: iohexol; Drug: triamcinolone/lidocaine
EXPERIMENTAL: 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.	Device: Havel's Inc. EchoStim (facet tip) 21 Gauge 4" needle; Drug: triamcinolone/lidocaine; 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; Device: SonoSite S-nerve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Minutes Between a Sacroiliac Joint Injection Done With Ultrasound vs Fluoroscopy	during procedure from the time monitors are placed on patient to the time of withdrawal of needle from skin	difference in minutes between a sacroiliac joint injection, an expected average of 9 minutes
Change in Pain Score From Baseline to 30 Minutes Pre-procedure Using the Defense and Veterans Pain Rating Scale (DoD/VA PRS) 0-10	Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.	30 minutes pre-procedure minus baseline
Change in Pain Score From Baseline to 2 Weeks Post-procedure Using the DoD/VA PRS	Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.	2 weeks post-procedure minus baseline
Change in Pain Score From Baseline to 3 Months Post-procedure Using the DoD/VA PRS	Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.	3 months post-procedure minus baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impression of Change of Condition at 2 Weeks Post-procedure Using the Patient Global Impression of Change (PGIC) Scale	Study subjects rate their change in overall condition on a scale of 0-6 (0=no change, 6=better and a definite improvement that has made a real worthwhile difference). The range of the change in pain for both groups observed was in fact 0-5.	2 weeks post-procedure
Impression of Change of Condition at 3 Months Post-procedure Using the PGIC Scale	Study subjects rate their change in overall condition on a scale of 0-6 (0=no change, 6=better and a definite improvement that has made a real worthwhile difference). The range of the change in pain for both groups observed was in fact 0-5.	3 months post-procedure
Change in Pain Score Since Sacroiliac (SI) Injection at 2 Weeks Post-procedure Using the DoD/VA PRS	Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome. Score reported is reporting a difference/change between two time points.	during/just before sacroiliac (SI) injection and 2 weeks post-procedure
Change in Pain Score Since SI Injection at 3 Months Post-procedure Using the DoD/VA PRS	Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.Score reported is reporting a difference/change between two time points.	during/just before sacroiliac (SI) injection and 3 months post-procedure
Satisfaction of Procedure as a Measure of Safety and Tolerability Using a Numerical Scale 1-5	"1= very dissatisfied" to "5=very satisfied".	2 weeks post-procedure
Satisfaction of Procedure as a Measure of Safety and Tolerability Using a Numerical Scale 1-5	"1= very dissatisfied" to "5=very satisfied".	3 months post-procedure

Collaborators and Investigators

• Sponsor: United States Naval Medical Center, San Diego
• Collaborators: United States Naval Medical Center, Portsmouth

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: September 30, 2014
• First Submitted That Met QC Criteria: April 16, 2015
• First Posted (ESTIMATE): April 17, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): November 13, 2015
• Last Update Submitted That Met QC Criteria: October 7, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Ultrasound; Fluoroscopy; Sacroiliac Joint Injection
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis; Sacroiliitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Triamcinolone
• Other Study ID Numbers: NMCSD.2012.0112