Comparing the Effects of Ultrasound Versus Fluoroscopy for Sacroiliac Joint Injections

Sacroiliitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02420041
• Other study ID #: NMCSD.2012.0112
• Status: Completed
• Phase: N/A
• First received: September 30, 2014
• Last updated: October 7, 2015
• Start date: October 2012
• Est. completion date: March 2014

Study information

• Verified date: October 2015
• Source: United States Naval Medical Center, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sacroiliitis

Intervention

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

• SonoSite S-nerve

• iohexol

Drug:
• triamcinolone/lidocaine

Locations

Country	Name	City	State
United States	Pain Medicine Center, Department of Anesthesiology, Naval Medical Center, San Diego	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
United States Naval Medical Center, San Diego	United States Naval Medical Center, Portsmouth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No