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Completed

NCT Number: NCT02420041

Comparing the Effects of Ultrasound Versus Fluoroscopy for Sacroiliac Joint Injections

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

San Diego, California, 92134, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active comparator: Fluoroscopic Guided SIJ injection

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

Ultrasound Guided Sacroiliac Joint Injection

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

Device

SonoSite S-nerve

Device

iohexol

Device

triamcinolone/lidocaine

Drug

Primary outcomes

  1. Difference in Minutes Between a Sacroiliac Joint Injection Done With Ultrasound vs Fluoroscopy

    Time frame: difference in minutes between a sacroiliac joint injection, an expected average of 9 minutes

    during procedure from the time monitors are placed on patient to the time of withdrawal of needle from skin

  2. Change in Pain Score From Baseline to 30 Minutes Pre-procedure Using the Defense and Veterans Pain Rating Scale (DoD/VA PRS) 0-10

    Time frame: 30 minutes pre-procedure minus baseline

    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. Change in Pain Score From Baseline to 2 Weeks Post-procedure Using the DoD/VA PRS

    Time frame: 2 weeks post-procedure minus baseline

    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.

  4. Change in Pain Score From Baseline to 3 Months Post-procedure Using the DoD/VA PRS

    Time frame: 3 months post-procedure minus baseline

    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.

Secondary outcomes

  1. Impression of Change of Condition at 2 Weeks Post-procedure Using the Patient Global Impression of Change (PGIC) Scale

    Time frame: 2 weeks post-procedure

    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. Impression of Change of Condition at 3 Months Post-procedure Using the PGIC Scale

    Time frame: 3 months post-procedure

    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. Change in Pain Score Since Sacroiliac (SI) Injection at 2 Weeks Post-procedure Using the DoD/VA PRS

    Time frame: during/just before sacroiliac (SI) injection and 2 weeks post-procedure

    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.

  4. Change in Pain Score Since SI Injection at 3 Months Post-procedure Using the DoD/VA PRS

    Time frame: during/just before sacroiliac (SI) injection and 3 months post-procedure

    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.

  5. Satisfaction of Procedure as a Measure of Safety and Tolerability Using a Numerical Scale 1-5

    Time frame: 2 weeks post-procedure

    "1= very dissatisfied" to "5=very satisfied".

  6. Satisfaction of Procedure as a Measure of Safety and Tolerability Using a Numerical Scale 1-5

    Time frame: 3 months post-procedure

    "1= very dissatisfied" to "5=very satisfied".

Sponsors and collaborators

Lead sponsor

United States Naval Medical Center, San Diego

Fed

Collaborators

  • United States Naval Medical Center, Portsmouth

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 17, 2015
Registry last updated
Nov 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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