SI Joint Pain Clinical Trial
— VaReFiOfficial title:
VaReFi Validity and Reliability of Diagnostic Findings of SI Joint Blocking
| Verified date | September 2019 |
| Source | SI-BONE, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of the trial is to confirm the validity and reliability of diagnostic SI joint blocks.
| Status | Terminated |
| Enrollment | 28 |
| Est. completion date | September 30, 2014 |
| Est. primary completion date | September 30, 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years to 75 Years |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| United States | Cleveland Clinic | Cleveland | Ohio |
| United States | Penn State College Of Medicine | Hershey | Pennsylvania |
| United States | Bluegrass Orthopaedics and Hand Care Research, LLC | Lexington | Kentucky |
| United States | Orthopedic Center of Southern Illinois | Mount Vernon | Illinois |
| United States | Virginia iSpine Research Institute, Inc | Richmond | Virginia |
| United States | Physicians' Research Options, LLC | Sandy | Utah |
| United States | Precision Spine Care | Tyler | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| SI-BONE, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 |