SI Joint PainPhase 4VaReFiNCT01874236
Validity and Reliability of Diagnostic Findings of SI Joint Blocking
A Phase 4 study testing 0.75% bupivacaine and .75% bupivacaine in people with SI Joint Pain, run by SI-BONE, Inc. at 7 sites in United States.
Trial summary
The purpose of the trial is to confirm the validity and reliability of diagnostic SI joint blocks. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- SI Joint Pain
- What is being tested?
- 0.75% bupivacaine and .75% bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 7 sitesUnited States
- Study dates
- 22 Apr 2013to 30 Sep 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Show all 13Show fewer
- 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)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Cleveland Clinic
Cleveland, Ohio, 44195
Penn State College Of Medicine
Hershey, Pennsylvania, 17033
Bluegrass Orthopaedics and Hand Care Research, LLC
Lexington, Kentucky, 40509
Orthopedic Center of Southern Illinois
Mount Vernon, Illinois, 62864
Virginia iSpine Research Institute, Inc
Richmond, Virginia, 23235
Physicians' Research Options, LLC
Sandy City, Utah, 84070
Precision Spine Care
Tyler, Texas, 75701
About this study
Official title: 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.
Read the 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.
- Conditions
- SI Joint Pain
- Being tested
- 0.75% bupivacaine, .75% bupivacaine
- Keywords
- SI joint pain, SI joint dysfunction, degenerative sacroiliitis, sacroiliac joint disruption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.75% bupivacaineDrug
Also called Blinded 3 blocks (2 bupivacaine, 1 sham block)
Week 1: SI joint injection with .75% bupivacaine Week 2: SI joint injection with .75% bupivacaine Week 3: SI joint sham block
.75% bupivacaineDrug
Also called Blinded 3 blocks (2 bupivacaine, 1 sham block)
Week 1: SI join sham block Week 2: SI joint injection with .75% bupivacaine Week 3: SI joint injection with .75% bupivacaine
.75% bupivacaineDrug
Also called Blinded 3 blocks (2 .75% bupivacaine, 1 sham block)
Week 1: SI join injection with .75% bupivacaine Week 2: SI join sham block Week 3: SI joint injection with .75% bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| 1st sequence | Active comparator | Blinded 3 blocks (2 bupivacaine, 1 sham block) Receives: Drug: 0.75% bupivacaine |
| 2nd sequence | Active comparator | Blinded 3 blocks (2 bupivacaine, 1 sham block) Receives: Drug: .75% bupivacaine |
| 3rd sequence | Active comparator | Blinded 3 blocks (2 bupivacaine, 1 sham block) Receives: Drug: .75% bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 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).
Look at responses in patients who have been diagnosed with an SI joint condition vs. patients who have no SI joint condition diagnosis.
Measured: 7 weeks after 1st block & and 27 weeks after 1st block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study start22 Apr 2013
- Primary completion30 Sep 2014
- Study completion30 Sep 2014
Why it stopped: Data could not be interpreted. Re-design efforts failed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SI Joint PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- SI-BONE, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aaron Calodney, MD, Principal investigator, Texas Spine and Joint Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874236
- Sponsor's protocol ID
- 300164
- Acronym
- VaReFi
- Status last verified
- Sep 2019
- First submitted
- 30 May 2013
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VaReFi Validity and Reliability of Diagnostic Findings of SI Joint Blocking
- ClinicalTrials.gov ID
- NCT01874236
- Acronym / sponsor ID
- VaReFi / 300164
- Conditions
- SI Joint Pain
- Keywords
- SI joint pain, SI joint dysfunction, degenerative sacroiliitis, sacroiliac joint disruption
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Data could not be interpreted. Re-design efforts failed.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- SI-BONE, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Apr 2013 (actual)
- Primary completion
- 30 Sep 2014 (actual)
- Study completion
- 30 Sep 2014 (actual)
- First posted
- 10 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1st sequence | Active comparator | Drug: 0.75% bupivacaineBlinded 3 blocks (2 bupivacaine, 1 sham block) |
| 2nd sequence | Active comparator | Drug: .75% bupivacaineBlinded 3 blocks (2 bupivacaine, 1 sham block) |
| 3rd sequence | Active comparator | Drug: .75% bupivacaineBlinded 3 blocks (2 bupivacaine, 1 sham block) |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.75% bupivacaineAlso: Blinded 3 blocks (2 bupivacaine, 1 sham block)Week 1: SI joint injection with .75% bupivacaine Week 2: SI joint injection with .75% bupivacaine Week 3: SI joint sham block | Drug | 1st sequence |
| .75% bupivacaineAlso: Blinded 3 blocks (2 bupivacaine, 1 sham block)Week 1: SI join sham block Week 2: SI joint injection with .75% bupivacaine Week 3: SI joint injection with .75% bupivacaine | Drug | 2nd sequence |
| .75% bupivacaineAlso: Blinded 3 blocks (2 .75% bupivacaine, 1 sham block)Week 1: SI join injection with .75% bupivacaine Week 2: SI join sham block Week 3: SI joint injection with .75% bupivacaine | Drug | 3rd sequence |
Primary outcome
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).
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?
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Data could not be interpreted. Re-design efforts failed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
Related trials for SI Joint Pain
RecruitingPhase 4
LINQ® Procedure vs. Conventional Medical Management for Sacroiliac Dysfunction
Sacroiliac Joint Pain
Not yet recruiting
QIPB vs SI-FICB for Postoperative Analgesia After Total Hip Arthroplasty
Hip Osteoarthritis, Total Hip Arthroplasty (THA)
Not yet recruitingObservational study
Posterior-Inferior Intra-articular Cortical Piercing Titanium Implant for Sacroiliac Joint Fusion: Evaluation of Safety and Effectiveness Outcomes
Sacro Iliac Joint Pain, Sacro-iliac Joints
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron Calodney, MD principal investigator
Texas Spine and Joint Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.75% bupivacaine and .75% bupivacaine in people with SI Joint Pain, run by SI-BONE, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Data could not be interpreted. Re-design efforts failed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2019.