Clinical trial NCT01874236: Validity and Reliability of Diagnostic Findings of SI Joint Blocking
Official title: VaReFi Validity and Reliability of Diagnostic Findings of SI Joint Blocking
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: SI Joint Pain
Keywords: SI joint pain, SI joint dysfunction, degenerative sacroiliitis, sacroiliac joint disruption
Lead sponsor: SI-BONE, Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-10
Enrollment: 28
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Numeric Rating Scale
timeFrame: 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 outcomes:
measure: 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).
timeFrame: 7 weeks after 1st block & and 27 weeks after 1st block
Other outcomes:
Locations:
city: Mount Vernon
country: United States
facility: Orthopedic Center of Southern Illinois
state: Illinois
city: Lexington
country: United States
facility: Bluegrass Orthopaedics and Hand Care Research, LLC
state: Kentucky
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Hershey
country: United States
facility: Penn State College Of Medicine
state: Pennsylvania
city: Tyler
country: United States
facility: Precision Spine Care
state: Texas
city: Sandy
country: United States
facility: Physicians' Research Options, LLC
state: Utah
city: Richmond
country: United States
facility: Virginia iSpine Research Institute, Inc
state: Virginia
Study officials:
affiliation: Texas Spine and Joint Hospital
name: Aaron Calodney, MD
role: PRINCIPAL_INVESTIGATOR
References: