Trial Outcomes & Findings for Comparing the Effects of Ultrasound Versus Fluoroscopy for Sacroiliac Joint Injections (NCT NCT02420041)
NCT ID: NCT02420041
Last Updated: 2015-11-13
Results Overview
during procedure from the time monitors are placed on patient to the time of withdrawal of needle from skin
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
difference in minutes between a sacroiliac joint injection, an expected average of 9 minutes
Results posted on
2015-11-13
Participant Flow
Participant milestones
| Measure |
Fluoroscopic Guidance
In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.
* Needle entry point is in the lower one-third of the sacroiliac joint (SIJ)
* Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a coaxial fashion into the SIJ
|
Ultrasound Guidance
In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.
* 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.
* Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a medial to lateral direction and guided into the SIJ.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing the Effects of Ultrasound Versus Fluoroscopy for Sacroiliac Joint Injections
Baseline characteristics by cohort
| Measure |
Fluoroscopic Guidance
n=14 Participants
In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.
* Needle entry point is in the lower one-third of the SIJ
* Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a coaxial fashion into the SIJ
|
Ultrasound Guidance
n=14 Participants
In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.
* 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.
* Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a medial to lateral direction and guided into the SIJ.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37 years
STANDARD_DEVIATION 7.6175 • n=5 Participants
|
34.07 years
STANDARD_DEVIATION 8.2695 • n=7 Participants
|
35.535 years
STANDARD_DEVIATION 7.9435 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: difference in minutes between a sacroiliac joint injection, an expected average of 9 minutesduring procedure from the time monitors are placed on patient to the time of withdrawal of needle from skin
Outcome measures
| Measure |
Fluoroscopic Guidance
n=14 Participants
In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.
* Needle entry point is in the lower one-third of the SIJ
* Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a coaxial fashion into the SIJ
|
Ultrasound Guidance
n=14 Participants
In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.
* 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.
* Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a medial to lateral direction and guided into the SIJ.
|
|---|---|---|
|
Difference in Minutes Between a Sacroiliac Joint Injection Done With Ultrasound vs Fluoroscopy
|
9.471 minutes
Interval 6.92 to 15.0
|
9.552 minutes
Interval 3.0 to 30.0
|
PRIMARY outcome
Timeframe: 30 minutes pre-procedure minus baselineStudy 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.
Outcome measures
| Measure |
Fluoroscopic Guidance
n=14 Participants
In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.
* Needle entry point is in the lower one-third of the SIJ
* Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a coaxial fashion into the SIJ
|
Ultrasound Guidance
n=14 Participants
In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.
* 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.
* Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a medial to lateral direction and guided into the SIJ.
|
|---|---|---|
|
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 units on a scale
Interval -5.0 to 0.0
|
-2.571 units on a scale
Interval -7.0 to 0.0
|
PRIMARY outcome
Timeframe: 2 weeks post-procedure minus baselineStudy 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.
Outcome measures
| Measure |
Fluoroscopic Guidance
n=14 Participants
In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.
* Needle entry point is in the lower one-third of the SIJ
* Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a coaxial fashion into the SIJ
|
Ultrasound Guidance
n=14 Participants
In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.
* 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.
* Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a medial to lateral direction and guided into the SIJ.
|
|---|---|---|
|
Change in Pain Score From Baseline to 2 Weeks Post-procedure Using the DoD/VA PRS
|
-1 units on a scale
Interval -3.0 to 0.0
|
-1.643 units on a scale
Interval -6.0 to 0.0
|
PRIMARY outcome
Timeframe: 3 months post-procedure minus baselinePopulation: numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study
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.
Outcome measures
| Measure |
Fluoroscopic Guidance
n=12 Participants
In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.
* Needle entry point is in the lower one-third of the SIJ
* Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a coaxial fashion into the SIJ
|
Ultrasound Guidance
n=9 Participants
In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.
* 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.
* Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a medial to lateral direction and guided into the SIJ.
|
|---|---|---|
|
Change in Pain Score From Baseline to 3 Months Post-procedure Using the DoD/VA PRS
|
-0.875 units on a scale
Interval -2.0 to 0.5
|
-1.556 units on a scale
Interval -5.0 to 0.0
|
SECONDARY outcome
Timeframe: 2 weeks post-procedurePopulation: Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.
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.
Outcome measures
| Measure |
Fluoroscopic Guidance
n=13 Participants
In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.
* Needle entry point is in the lower one-third of the SIJ
* Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a coaxial fashion into the SIJ
|
Ultrasound Guidance
n=14 Participants
In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.
* 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.
* Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a medial to lateral direction and guided into the SIJ.
|
|---|---|---|
|
Impression of Change of Condition at 2 Weeks Post-procedure Using the Patient Global Impression of Change (PGIC) Scale
|
2.385 units on a scale
Interval 0.0 to 5.0
|
2.714 units on a scale
Interval 0.0 to 5.0
|
SECONDARY outcome
Timeframe: 3 months post-procedurePopulation: Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.
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.
Outcome measures
| Measure |
Fluoroscopic Guidance
n=11 Participants
In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.
* Needle entry point is in the lower one-third of the SIJ
* Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a coaxial fashion into the SIJ
|
Ultrasound Guidance
n=9 Participants
In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.
* 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.
* Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a medial to lateral direction and guided into the SIJ.
|
|---|---|---|
|
Impression of Change of Condition at 3 Months Post-procedure Using the PGIC Scale
|
2.818 units on a scale
Interval 0.0 to 5.0
|
2.222 units on a scale
Interval 0.0 to 5.0
|
SECONDARY outcome
Timeframe: during/just before sacroiliac (SI) injection and 2 weeks post-procedurePopulation: Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.
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.
Outcome measures
| Measure |
Fluoroscopic Guidance
n=13 Participants
In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.
* Needle entry point is in the lower one-third of the SIJ
* Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a coaxial fashion into the SIJ
|
Ultrasound Guidance
n=13 Participants
In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.
* 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.
* Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a medial to lateral direction and guided into the SIJ.
|
|---|---|---|
|
Change in Pain Score Since Sacroiliac (SI) Injection at 2 Weeks Post-procedure Using the DoD/VA PRS
|
4.846 units on a scale
Interval 0.0 to 8.0
|
4.385 units on a scale
Interval 2.0 to 9.0
|
SECONDARY outcome
Timeframe: during/just before sacroiliac (SI) injection and 3 months post-procedurePopulation: Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.
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.
Outcome measures
| Measure |
Fluoroscopic Guidance
n=10 Participants
In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.
* Needle entry point is in the lower one-third of the SIJ
* Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a coaxial fashion into the SIJ
|
Ultrasound Guidance
n=9 Participants
In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.
* 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.
* Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a medial to lateral direction and guided into the SIJ.
|
|---|---|---|
|
Change in Pain Score Since SI Injection at 3 Months Post-procedure Using the DoD/VA PRS
|
4 units on a scale
Interval 1.0 to 7.0
|
4.333 units on a scale
Interval 3.0 to 8.0
|
SECONDARY outcome
Timeframe: 2 weeks post-procedurePopulation: Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.
"1= very dissatisfied" to "5=very satisfied".
Outcome measures
| Measure |
Fluoroscopic Guidance
n=13 Participants
In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.
* Needle entry point is in the lower one-third of the SIJ
* Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a coaxial fashion into the SIJ
|
Ultrasound Guidance
n=14 Participants
In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.
* 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.
* Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a medial to lateral direction and guided into the SIJ.
|
|---|---|---|
|
Satisfaction of Procedure as a Measure of Safety and Tolerability Using a Numerical Scale 1-5
|
3.615 units on a scale of satisfaction
Interval 1.0 to 5.0
|
3.857 units on a scale of satisfaction
Interval 2.0 to 5.0
|
SECONDARY outcome
Timeframe: 3 months post-procedurePopulation: Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.
"1= very dissatisfied" to "5=very satisfied".
Outcome measures
| Measure |
Fluoroscopic Guidance
n=11 Participants
In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.
* Needle entry point is in the lower one-third of the SIJ
* Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a coaxial fashion into the SIJ
|
Ultrasound Guidance
n=9 Participants
In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.
* 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.
* Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a medial to lateral direction and guided into the SIJ.
|
|---|---|---|
|
Satisfaction of Procedure as a Measure of Safety and Tolerability Using a Numerical Scale 1-5
|
3.364 units on a scale of satisfaction
Interval 2.0 to 4.0
|
3.667 units on a scale of satisfaction
Interval 3.0 to 4.0
|
Adverse Events
Fluoroscopic Guidance
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Ultrasound Guidance
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fluoroscopic Guidance
n=14 participants at risk
In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.
* Needle entry point is in the lower one-third of the SIJ
* Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a coaxial fashion into the SIJ
|
Ultrasound Guidance
n=14 participants at risk
In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.
* 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.
* Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a medial to lateral direction and guided into the SIJ.
|
|---|---|---|
|
Cardiac disorders
Vasovagal reaction
|
7.1%
1/14 • Number of events 1
All adverse events, including serious adverse events, were collected but none occurred. Data input includes all non-serious adverse events that occurred during this study.
|
7.1%
1/14 • Number of events 1
All adverse events, including serious adverse events, were collected but none occurred. Data input includes all non-serious adverse events that occurred during this study.
|
|
Musculoskeletal and connective tissue disorders
Facetogenic back pain
|
7.1%
1/14 • Number of events 1
All adverse events, including serious adverse events, were collected but none occurred. Data input includes all non-serious adverse events that occurred during this study.
|
7.1%
1/14 • Number of events 1
All adverse events, including serious adverse events, were collected but none occurred. Data input includes all non-serious adverse events that occurred during this study.
|
|
Musculoskeletal and connective tissue disorders
Lower back pain
|
7.1%
1/14 • Number of events 1
All adverse events, including serious adverse events, were collected but none occurred. Data input includes all non-serious adverse events that occurred during this study.
|
7.1%
1/14 • Number of events 1
All adverse events, including serious adverse events, were collected but none occurred. Data input includes all non-serious adverse events that occurred during this study.
|
|
Musculoskeletal and connective tissue disorders
Myofascial pain syndrome
|
7.1%
1/14 • Number of events 1
All adverse events, including serious adverse events, were collected but none occurred. Data input includes all non-serious adverse events that occurred during this study.
|
0.00%
0/14
All adverse events, including serious adverse events, were collected but none occurred. Data input includes all non-serious adverse events that occurred during this study.
|
|
Musculoskeletal and connective tissue disorders
Sacroiliac joint pain
|
7.1%
1/14 • Number of events 1
All adverse events, including serious adverse events, were collected but none occurred. Data input includes all non-serious adverse events that occurred during this study.
|
0.00%
0/14
All adverse events, including serious adverse events, were collected but none occurred. Data input includes all non-serious adverse events that occurred during this study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place