Validity and Reliability of Diagnostic Findings of SI Joint Blocking (VaReFi)

VaReFi Validity and Reliability of Diagnostic Findings of SI Joint Blocking

The purpose of the trial is to confirm the validity and reliability of diagnostic SI joint blocks.

Study Overview

• Status: Terminated
• Conditions: SI Joint Pain
• Intervention / Treatment: Drug: 0.75% bupivacaine; Drug: .75% bupivacaine; Drug: .75% bupivacaine

Detailed Description

Subjects with suspected SI joint pain will undergo 3 SI joint blocks, 2 with local anesthetic and 1 sham block.

The sequence of blocks is randomly assigned. This study examines both the test-retest reliability of response to diagnostic sacroiliac (SI) joint injection and the specificity of response to local anesthetic or sham block. The goal of the study is to validate the use of diagnostic SI joint block.

Subjects with pain suspected to be generated by one SI joint will undergo three diagnostic SI joint blocks each separated by one week. Two blocks will be with local anesthetic (LA) and one will be a sham block (SB). Both the Coordinator (collecting pain assessments) and subject will be blinded to the sequence of blocks (LA or SB each time). The sequence of blocks will be randomly assigned for each subject on study. The subject's participation in the study is complete after 6-month post-procedure assessment.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Mount Vernon, Illinois, United States, 62864
      • Orthopedic Center of Southern Illinois
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Bluegrass Orthopaedics and Hand Care Research, LLC
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State College of Medicine
  • Texas
    • Tyler, Texas, United States, 75701
      • Precision Spine Care
  • Utah
    • Sandy, Utah, United States, 84070
      • Physicians' Research Options, LLC
  • Virginia
    • Richmond, Virginia, United States, 23235
      • Virginia iSpine Research Institute, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 21-75 at time of screening.
2. Patient has buttocks, groin and/or leg pain suspected to be from one SI joint (left or right).
3. Patient has positive Fortin finger test*.
4. Patient has a current average SI joint pain rating of at least 5 on 0-10 numerical rating scale**.
5. Patient has at least 3 positive physical SI joint examination findings in the targeted SI joint.
6. Investigator believes that diagnostic SI joint block is indicated now, and that no other (hip/back, etc.) diagnostic test is required at this time.
7. Patient has signed study-specific informed consent form.
8. Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements (including avoiding taking pain medication 8 hours prior to and 4 hours after each scheduled block).

Exclusion Criteria:

1. Patient has history of any surgical procedure of the targeted SI joint (except for prior RF ablation of the SI joint).
2. Patient has suspected bilateral SIJ pain and bilateral injections are indicated.
3. Patient has history of chronic pain syndrome (e.g., fibromyalgia).
4. Patient has any medical or other condition that would interfere with study participation or data validity.
5. Patient is currently pregnant.
6. Patient has known allergy to contrast used or local anesthetic used (bupivacaine).
7. Patient has had one or more steroid SI joint injection(s) of the targeted side in the last 3 months.
8. Patient is a prisoner or a ward of the state.
9. Patient is participating in another investigational study related to back or SI joint pain (Exclude if participating in trials other than the SIFI study (NCT01640353) or the INSITE Study (NCT01681004). Subjects on these two SI-BONE sponsored trials may be eligible for VaReFi.)
10. Patient is known or suspected drug or alcohol abuser.
11. Patient has known or suspected psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation .
12. Patient is unable to isolate suspected SI joint pain to the SI joint but rather has generalized pain.
13. Patient has known or suspected alternative cause for pain at/near SI joint (e.g., lumbar disc degeneration, lumbar facet arthropathy, hip osteoarthritis or labral tear)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1st sequence; Blinded 3 blocks (2 bupivacaine, 1 sham block)	Drug: 0.75% bupivacaine; Week 1: SI joint injection with .75% bupivacaine Week 2: SI joint injection with .75% bupivacaine Week 3: SI joint sham block; Other Names: Blinded 3 blocks (2 bupivacaine, 1 sham block)
Active Comparator: 2nd sequence; Blinded 3 blocks (2 bupivacaine, 1 sham block)	Drug: .75% bupivacaine; Week 1: SI join sham block Week 2: SI joint injection with .75% bupivacaine Week 3: SI joint injection with .75% bupivacaine; Other Names: Blinded 3 blocks (2 bupivacaine, 1 sham block); Drug: .75% bupivacaine; Week 1: SI join injection with .75% bupivacaine Week 2: SI join sham block Week 3: SI joint injection with .75% bupivacaine; Other Names: Blinded 3 blocks (2 .75% bupivacaine, 1 sham block)
Active Comparator: 3rd sequence; Blinded 3 blocks (2 bupivacaine, 1 sham block)	Drug: .75% bupivacaine; Week 1: SI join sham block Week 2: SI joint injection with .75% bupivacaine Week 3: SI joint injection with .75% bupivacaine; Other Names: Blinded 3 blocks (2 bupivacaine, 1 sham block); Drug: .75% bupivacaine; Week 1: SI join injection with .75% bupivacaine Week 2: SI join sham block Week 3: SI joint injection with .75% bupivacaine; Other Names: Blinded 3 blocks (2 .75% bupivacaine, 1 sham block)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rating Scale	Change in SI joint pain from prior to injection to 30 minutes, 60 minutes, 2 hours, 4 hours after injection. Changes compared over 3 injections, where type of block is blinded. Is response to bupivacaine different than response to sham block Is response to bupivacaine during second injection similar to that during first injection?	Baseline, 30 minutes and 60 minutes, 2 and 4 hours post injection (x 3 injections, each 1 week apart), and 1 month post 3rd injection visit (7 weeks post 1st injection).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subgroup analysis by diagnosis at 1 month post 3rd block (7 weeks post 1st injection) and 6 month post 3rd injection visit ( 27 weeks post 1st injection).	Look at responses in patients who have been diagnosed with an SI joint condition vs. patients who have no SI joint condition diagnosis.	7 weeks after 1st block & and 27 weeks after 1st block

Collaborators and Investigators

• Sponsor: SI-BONE, Inc.
• Investigators: Principal Investigator: Aaron Calodney, MD, Texas Spine and Joint Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2013
• Primary Completion (Actual): September 30, 2014
• Study Completion (Actual): September 30, 2014

Study Registration Dates

• First Submitted: May 30, 2013
• First Submitted That Met QC Criteria: June 7, 2013
• First Posted (Estimate): June 10, 2013

Study Record Updates

• Last Update Posted (Actual): September 24, 2019
• Last Update Submitted That Met QC Criteria: September 20, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: SI joint pain, SI joint dysfunction, degenerative sacroiliitis, sacroiliac joint disruption
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 300164