Validity and Reliability of Diagnostic Findings of SI Joint Blocking

NCT01874236 | Terminated Phase 4

• 1 other identifier: 300164
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

SI Joint Pain

Keywords

SI joint pain, SI joint dysfunction, degenerative sacroiliitis, sacroiliac joint disruption

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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).

  7 weeks after 1st block & and 27 weeks after 1st block

Study Arms (3)

1st sequence

ACTIVE COMPARATOR

Blinded 3 blocks (2 bupivacaine, 1 sham block)

Drug: 0.75% bupivacaine

2nd sequence

ACTIVE COMPARATOR

Blinded 3 blocks (2 bupivacaine, 1 sham block)

Drug: .75% bupivacaine

3rd sequence

ACTIVE COMPARATOR

Blinded 3 blocks (2 bupivacaine, 1 sham block)

Drug: .75% bupivacaine

Interventions

0.75% bupivacaine DRUG

Week 1: SI joint injection with .75% bupivacaine Week 2: SI joint injection with .75% bupivacaine Week 3: SI joint sham block

Also known as: Blinded 3 blocks (2 bupivacaine, 1 sham block)

1st sequence

.75% bupivacaine DRUG

Week 1: SI join sham block Week 2: SI joint injection with .75% bupivacaine Week 3: SI joint injection with .75% bupivacaine

Also known as: Blinded 3 blocks (2 bupivacaine, 1 sham block)

2nd sequence

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21-75 at time of screening.
• Patient has buttocks, groin and/or leg pain suspected to be from one SI joint (left or right).
• Patient has positive Fortin finger test\*.
• Patient has a current average SI joint pain rating of at least 5 on 0-10 numerical rating scale\*\*.
• Patient has at least 3 positive physical SI joint examination findings in the targeted SI joint.
• Investigator believes that diagnostic SI joint block is indicated now, and that no other (hip/back, etc.) diagnostic test is required at this time.
• Patient has signed study-specific informed consent form.
• 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).

You may not qualify if:

• Patient has history of any surgical procedure of the targeted SI joint (except for prior RF ablation of the SI joint).
• Patient has suspected bilateral SIJ pain and bilateral injections are indicated.
• Patient has history of chronic pain syndrome (e.g., fibromyalgia).
• Patient has any medical or other condition that would interfere with study participation or data validity.
• Patient is currently pregnant.
• Patient has known allergy to contrast used or local anesthetic used (bupivacaine).
• Patient has had one or more steroid SI joint injection(s) of the targeted side in the last 3 months.
• Patient is a prisoner or a ward of the state.
• 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.)
• Patient is known or suspected drug or alcohol abuser.
• Patient has known or suspected psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation .
• Patient is unable to isolate suspected SI joint pain to the SI joint but rather has generalized pain.
• 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)

Sponsors & Collaborators

• SI-BONE, Inc.: lead

Study Sites (7)

Orthopedic Center of Southern Illinois

Mount Vernon, Illinois, 62864, United States

Location

Bluegrass Orthopaedics and Hand Care Research, LLC

Lexington, Kentucky, 40509, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Penn State College Of Medicine

Hershey, Pennsylvania, 17033, United States

Location

Precision Spine Care

Tyler, Texas, 75701, United States

Location

Physicians' Research Options, LLC

Sandy City, Utah, 84070, United States

Location

Virginia iSpine Research Institute, Inc

Richmond, Virginia, 23235, United States

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Aaron Calodney, MD

  Texas Spine and Joint Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2013
• First Posted: June 10, 2013
• Study Start: April 22, 2013
• Primary Completion: September 30, 2014
• Study Completion: September 30, 2014
• Last Updated: September 24, 2019

Record last verified: 2019-09

Locations

US (7)