Comparing the Effects of Ultrasound Versus Fluoroscopy fo... | NCT02420041

NCT02420041

Status Module

Name	Class
United States Naval Medical Center, Portsmouth	FED

Oversight Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fluoroscopic Guidance	Active Comparator	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
Ultrasound Guidance	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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 Outcomes

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

Eligibility Module

Name	Affiliation	Role
Steven R Hanling, MD	United States Naval Medical Center, San Diego	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Pain Medicine Center, Department of Anesthesiology, Naval Medical Center, San Diego		San Diego	California	92134	United States

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	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 SIJ Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a coaxial fashion into the SIJ
BG001	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.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00014 BG00114 BG00228

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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

Posted

Mean

Full Range

minutes

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

ID	Title	Description
OG000	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 SIJ Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a coaxial fashion into the SIJ
OG001	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.

Units	Counts
Participants	OG00014 OG00114

Title

Denominators

Categories

Title	Measurements
	OG0009.471(6.92 to 15) OG0019.552(3 to 30)

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.

Posted

Mean

Full Range

units on a scale

30 minutes pre-procedure minus baseline

ID	Title	Description
OG000	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 SIJ Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a coaxial fashion into the SIJ
OG001	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.

Units	Counts

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.

Posted

Mean

Full Range

units on a scale

2 weeks post-procedure minus baseline

ID	Title	Description
OG000	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 SIJ Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a coaxial fashion into the SIJ
OG001	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.

Units	Counts
Participants

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.

numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study

Posted

Mean

Full Range

units on a scale

3 months post-procedure minus baseline

ID	Title	Description
OG000	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 SIJ Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a coaxial fashion into the SIJ
OG001	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.

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.

Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.

Posted

Mean

Full Range

units on a scale

2 weeks post-procedure

ID	Title	Description
OG000	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 SIJ Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a coaxial fashion into the SIJ
OG001	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.

Secondary

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

Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.

Posted

Mean

Full Range

units on a scale

3 months post-procedure

ID	Title	Description
OG000	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 SIJ Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a coaxial fashion into the SIJ
OG001	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.

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.

Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.

Posted

Mean

Full Range

units on a scale

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

ID	Title	Description
OG000	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 SIJ Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a coaxial fashion into the SIJ
OG001	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.

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.

Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.

Posted

Mean

Full Range

units on a scale

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

ID	Title	Description
OG000	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 SIJ Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a coaxial fashion into the SIJ
OG001	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.

Secondary

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

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

Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.

Posted

Mean

Full Range

units on a scale of satisfaction

2 weeks post-procedure

ID	Title	Description
OG000	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 SIJ Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a coaxial fashion into the SIJ
OG001	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.

Secondary

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

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

Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.

Posted

Mean

Full Range

units on a scale of satisfaction

3 months post-procedure

ID	Title	Description
OG000	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 SIJ Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a coaxial fashion into the SIJ
OG001	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.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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 SIJ Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4" needle is inserted in a coaxial fashion into the SIJ			0	14	5	14
EG001	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.			0	14	3	14

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Vasovagal reaction	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0011 events1 affected14 at risk
Facetogenic back pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0011 events1 affected14 at risk
Lower back pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0011 events1 affected14 at risk
Myofascial pain syndrome	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected14 at risk
Sacroiliac joint pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected14 at risk

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

ID	Term
D014221	Triamcinolone
D008012	Lidocaine

ID	Term
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds
D000588	Amines