Table 1.

Key eligibility criteria for SIJ pain

Inclusion criteria

Exclusion criteria

•Age 21–70 years at screening •Pain for at least 6 months (under the care of a physician) at or close to the posterior superior iliac spine with possible radiation into the buttocks, posterior thigh, or groin rated as ≥50 on a 0–100 visual analog scale •Positive Fortin finger test41 •At least three of five positive physical examination maneuvers that stress the SIJ42 •Improvement of at least 50% in pain after image-guided injection of 0.5 cc of contrast and up to 1.5 cc of local anesthetic (lidocaine, bupivacaine, or ropivacaine) into the target joint. All blocks were confirmed fluoroscopically by observation of contrast flowing into the target joint. Patients rated pain on a 0–10 numeric rating scale both immediately prior to the diagnostic block and at 30 minutes and 60 minutes after the block •Diagnosis of either degenerative sacroiliitis (based on a history or prior lumbar spine fusion or radiographic signs of degeneration in the SIJ) or sacroiliac joint disruption (based on radiographic widening of the target SI joint, or leakage of contrast on a diagnostic arthrogram) •Oswestry Disability Index score of at least 30%

•Severe residual back pain due to other causes •Other sacroiliac pathology (for example, tumor, fracture, inflammatory spondylitis) •Recent (<1 year ago) major trauma •Diagnosed or suspected osteoporosis •Pregnancy •Known or suspected drug abuse •Uncontrolled psychiatric disease

Note: See NCT01640353, NCT01681004 on clinicaltrials.gov for details.21,22

Abbreviation: SIJ, sacroiliac joint.