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 range21 Years – 75 Years
SexALL
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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.
✓. 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.
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).