Validity and Reliability of Diagnostic Findings of SI Joint Blocking (NCT01874236) | Clinical Trial Compass
TerminatedPhase 4
Validity and Reliability of Diagnostic Findings of SI Joint Blocking
Stopped: Data could not be interpreted. Re-design efforts failed.
United States28 participantsStarted 2013-04-22
Plain-language summary
The purpose of the trial is to confirm the validity and reliability of diagnostic SI joint blocks.
Who can participate
Age range
21 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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).
. 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
. 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.