NCT02420041

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2014

Completed
7 months until next milestone

First Posted

Study publicly available on registry

April 17, 2015

Completed
7 months until next milestone

Results Posted

Study results publicly available

November 13, 2015

Completed
Last Updated

November 13, 2015

Status Verified

October 1, 2015

Enrollment Period

1.4 years

First QC Date

September 30, 2014

Results QC Date

June 26, 2015

Last Update Submit

October 7, 2015

Conditions

Sacroiliitis

Keywords

Sacroiliac Joint InjectionFluoroscopyUltrasound

Outcome Measures

Primary Outcomes (4)

  • 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 (6)

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

    2 weeks post-procedure

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

    3 months post-procedure

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

    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

    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

    2 weeks post-procedure

  • +1 more secondary outcomes

Study Arms (2)

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 injectionDevice: Havel's Inc. EchoStim (facet tip) 21 Gauge 4" needleDevice: iohexolDrug: 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 InjectionDevice: Havel's Inc. EchoStim (facet tip) 21 Gauge 4" needleDevice: SonoSite S-nerveDrug: triamcinolone/lidocaine

Interventions

Active comparator: Fluoroscopic Guided SIJ injectionPROCEDURE

* 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

Fluoroscopic Guidance
Ultrasound Guided Sacroiliac Joint InjectionPROCEDURE

* 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

Ultrasound Guidance
Havel's Inc. EchoStim (facet tip) 21 Gauge 4" needleDEVICE
Fluoroscopic GuidanceUltrasound Guidance
SonoSite S-nerveDEVICE
Ultrasound Guidance
iohexolDEVICE
Fluoroscopic Guidance
triamcinolone/lidocaineDRUG
Fluoroscopic GuidanceUltrasound Guidance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

San Diego, California, 92134, United States

Location

MeSH Terms

Conditions

Sacroiliitis

Interventions

TriamcinoloneLidocaine

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
LCDR Ian M Fowler, MD
Organization
Naval Medical Center San Diego
ian.m.fowler.mil@mail.mil
619-532-8954

Study Officials

  • Steven R Hanling, MD

    United States Naval Medical Center, San Diego

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2014

First Posted

April 17, 2015

Study Start

October 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

November 13, 2015

Results First Posted

November 13, 2015

Record last verified: 2015-10

Locations

US(1)