Comparing the Effects of Ultrasound Versus Fluoroscopy for Sacroiliac Joint Injections

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sacroiliitis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Failed a trial of conservative therapy which may included medications, physical therapy, or both Age > 18 Patient agrees to participate in study Exclusion Criteria: Coagulopathy Renal or Hepatic Failure Current Pregnancy or actively pursuing pregnancy Known allergy to local anesthetic or steroids Infection at site of needle placement or SIJ infection Patient unable to consent himself or herself Patient refusal Prior surgical procedures involving the SIJ Body Mass Index > 35 kg/m2

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fluoroscopic Guidance<br>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<br>* 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<br>Device: Havel's Inc. EchoStim (facet tip) 21 Gauge 4 needle<br> <br> Device: iohexol<br> <br> Drug: triamcinolone/lidocaine<br> <br> |
| Experimental: Ultrasound Guidance<br>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. | Procedure: Ultrasound Guided Sacroiliac Joint Injection<br>* 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<br>Device: Havel's Inc. EchoStim (facet tip) 21 Gauge 4 needle<br> <br> Device: SonoSite S-nerve<br> <br> Drug: triamcinolone/lidocaine<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sacroiliac Joint Injection, Fluoroscopy, Ultrasound