Trial record 2 of 80 for:    si-bone

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by SI-BONE, Inc.
Sponsor:
Information provided by (Responsible Party):
SI-BONE, Inc.
ClinicalTrials.gov Identifier:
NCT01874236
First received: May 30, 2013
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention Phase
SI Joint Pain
Drug: 0.75% bupivacaine
Drug: .75% bupivacaine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: VaReFi Validity and Reliability of Diagnostic Findings of SI Joint Blocking

Resource links provided by NLM:


Further study details as provided by SI-BONE, Inc.:

Primary Outcome Measures:
  • Numeric Rating Scale [ Time Frame: 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). ] [ Designated as safety issue: No ]

    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?



Secondary Outcome Measures:
  • 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). [ Time Frame: 7 weeks after 1st block & and 27 weeks after 1st block ] [ Designated as safety issue: No ]
    Look at responses in patients who have been diagnosed with an SI joint condition vs. patients who have no SI joint condition diagnosis.


Estimated Enrollment: 80
Study Start Date: June 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Blinded 3 blocks (2 bupivacaine, 1 sham block)
Active Comparator: 3rd sequence
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 Name: Blinded 3 blocks (2 .75% bupivacaine, 1 sham block)

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

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01874236

Contacts
Contact: Kathryn Wine, MPH 415-990-4104 kwine@si-bone.com
Contact: Daniel C Cher, MD 650-269-5763 dcher@si-bone.com

Locations
United States, Illinois
Orthopedic Center of Southern Illinois Recruiting
Mt. Vernon, Illinois, United States, 62864
Contact: Rosebel Blagoue    618-242-3778    roseyb320@gmail.com   
Principal Investigator: Aiping F. Smith, MD, MS         
United States, Kentucky
Bluegrass Orthopaedics and Hand Care Research, LLC Recruiting
Lexington, Kentucky, United States, 40509
Contact: Elaine Wilhite       eschuwilhite@gmail.com   
Principal Investigator: Harry Lockstadt, MD         
Sub-Investigator: Jim Farris, PA-C         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Michael Zeleny    216-445-1861    ZELENYM@ccf.org   
Principal Investigator: Eric Mayer, MD         
Sub-Investigator: Russell DeMicco, MD         
Sub-Investigator: Adrian Zachary, DO         
United States, Pennsylvania
Penn State College Of Medicine Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Swati Shah       sshah@hmc.psu.edu   
Principal Investigator: Dan Nguyen, MD         
United States, Texas
Scott & White Memorial Hospital Recruiting
Temple, Texas, United States, 76508
Contact: Vanessa Hoelscher    254-724-2150    VHOELSCHER@sw.org   
Contact: tina amlin    254-724-2150    tamlin@sw.org   
Principal Investigator: Christopher Burnett, MD         
Precision Spine Care Recruiting
Tyler, Texas, United States, 75701
Contact: Beth Short, BSN, MS    903-561-0566      
Principal Investigator: Aaron Calodney, MD         
United States, Utah
Physicians' Research Options, LLC Recruiting
Sandy, Utah, United States, 84070
Contact: Michael Braun    801-352-9228    braun@proslc.com   
Principal Investigator: Michael Giovanniello, MD         
United States, Virginia
Virginia iSpine Research Institute, Inc Recruiting
Richmond, Virginia, United States, 23235
Contact: Sandra (Kay) K Bovee, CRC    804-330-0303    crc@vaispine.com   
Principal Investigator: Michael J. DePalma, MD         
Sponsors and Collaborators
SI-BONE, Inc.
Investigators
Principal Investigator: Aaron Calodney, MD Texas Spine and Joint Hospital
  More Information

No publications provided

Responsible Party: SI-BONE, Inc.
ClinicalTrials.gov Identifier: NCT01874236     History of Changes
Other Study ID Numbers: 300164
Study First Received: May 30, 2013
Last Updated: September 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by SI-BONE, Inc.:
SI joint pain, SI joint dysfunction, degenerative sacroiliitis, sacroiliac joint disruption

Additional relevant MeSH terms:
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms
Bupivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014