An interventional study of Active comparator: Fluoroscopic Guided SIJ injection and Ultrasound Guided Sacroiliac Joint Injection in Sacroiliitis, sponsored by United States Naval Medical Center, San Diego. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-11-13.
Sponsored by United States Naval Medical Center, San Diego · Not applicable, Interventional, and Treatment
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.
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.
42 studies on the registry are indexed under Sacroiliitis; 11 are open to participants now.
This study's enrollment of 28 is below the median of 48 across 28 interventional studies indexed under Sacroiliitis.
Browse Sacroiliitis studies →United States Naval Medical Center, San Diego is the lead sponsor of 65 studies on the registry; 6 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of SIJ dysfunction by history and physical exam
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Device: Havel's Inc. EchoStim (facet tip) 21 Gauge 4" needle · Device: iohexol · Drug: triamcinolone/lidocaine
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 · Device: Havel's Inc. EchoStim (facet tip) 21 Gauge 4" needle · Device: SonoSite S-nerve · Drug: triamcinolone/lidocaine
* 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
* 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
Drug pages: Triamcinolone · Lidocaine
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months post-procedure minus baseline
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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".
Time frame: 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".
Time frame: 3 months post-procedure
| Milestone | Fluoroscopic Guidance | Ultrasound Guidance |
|---|---|---|
| Started | 14 | 14 |
| Completed | 14 | 14 |
| Not completed | 0 | 0 |
during procedure from the time monitors are placed on patient to the time of withdrawal of needle from skin
| minutes | Fluoroscopic Guidance | Ultrasound Guidance |
|---|---|---|
| Difference in Minutes Between a Sacroiliac Joint Injection Done With Ultrasound vs Fluoroscopy | 9.471 (6.92 to 15) | 9.552 (3 to 30) |
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.
| units on a scale | Fluoroscopic Guidance | Ultrasound Guidance |
|---|---|---|
| Change in Pain Score From Baseline to 30 Minutes Pre-procedure Using the Defense and Veterans Pain Rating Scale (DoD/VA PRS) 0-10 | -2.571 (-5 to 0) | -2.571 (-7 to 0) |
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.
| units on a scale | Fluoroscopic Guidance | Ultrasound Guidance |
|---|---|---|
| Change in Pain Score From Baseline to 2 Weeks Post-procedure Using the DoD/VA PRS | -1 (-3 to 0) | -1.643 (-6 to 0) |
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.
| units on a scale | Fluoroscopic Guidance | Ultrasound Guidance |
|---|---|---|
| Change in Pain Score From Baseline to 3 Months Post-procedure Using the DoD/VA PRS | -0.875 (-2 to .5) | -1.556 (-5 to 0) |
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.
| units on a scale | Fluoroscopic Guidance | Ultrasound Guidance |
|---|---|---|
| Impression of Change of Condition at 2 Weeks Post-procedure Using the Patient Global Impression of Change (PGIC) Scale | 2.385 (0 to 5) | 2.714 (0 to 5) |
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.
| units on a scale | Fluoroscopic Guidance | Ultrasound Guidance |
|---|---|---|
| Impression of Change of Condition at 3 Months Post-procedure Using the PGIC Scale | 2.818 (0 to 5) | 2.222 (0 to 5) |
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.
| units on a scale | Fluoroscopic Guidance | Ultrasound Guidance |
|---|---|---|
| Change in Pain Score Since Sacroiliac (SI) Injection at 2 Weeks Post-procedure Using the DoD/VA PRS | 4.846 (0 to 8) | 4.385 (2 to 9) |
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.
| units on a scale | Fluoroscopic Guidance | Ultrasound Guidance |
|---|---|---|
| Change in Pain Score Since SI Injection at 3 Months Post-procedure Using the DoD/VA PRS | 4 (1 to 7) | 4.333 (3 to 8) |
"1= very dissatisfied" to "5=very satisfied".
| units on a scale of satisfaction | Fluoroscopic Guidance | Ultrasound Guidance |
|---|---|---|
| Satisfaction of Procedure as a Measure of Safety and Tolerability Using a Numerical Scale 1-5 | 3.615 (1 to 5) | 3.857 (2 to 5) |
"1= very dissatisfied" to "5=very satisfied".
| units on a scale of satisfaction | Fluoroscopic Guidance | Ultrasound Guidance |
|---|---|---|
| Satisfaction of Procedure as a Measure of Safety and Tolerability Using a Numerical Scale 1-5 | 3.364 (2 to 4) | 3.667 (3 to 4) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fluoroscopic Guidance | — | 0/14 (0%) | 5/14 (35.7%) |
| Ultrasound Guidance | — | 0/14 (0%) | 3/14 (21.4%) |
| Event | Fluoroscopic Guidance | Ultrasound Guidance |
|---|---|---|
| Vasovagal reactionCardiac disorders | 1/14 | 1/14 |
| Facetogenic back painMusculoskeletal and connective tissue disorders | 1/14 | 1/14 |
| Lower back painMusculoskeletal and connective tissue disorders | 1/14 | 1/14 |
| Myofascial pain syndromeMusculoskeletal and connective tissue disorders | 1/14 | 0/14 |
| Sacroiliac joint painMusculoskeletal and connective tissue disorders | 1/14 | 0/14 |
| Age, Continuous(years) | Fluoroscopic Guidance | Ultrasound Guidance | Total |
|---|---|---|---|
| Mean | 37 ± 7.6175 | 34.07 ± 8.2695 | 35.535 ± 7.9435 |
| Sex: Female, Male(Participants) | Fluoroscopic Guidance | Ultrasound Guidance | Total |
|---|---|---|---|
| Female | 6 | 5 | 11 |
| Male | 8 | 9 | 17 |
| Region of Enrollment(participants) | Fluoroscopic Guidance | Ultrasound Guidance | Total |
|---|---|---|---|
| United States | 14 | 14 | 28 |
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United States Naval Medical Center, San Diego