NCT06268704 Particulate vs. Non-Particulate Steroid for Sacroiliac Joint Injection
| NCT ID | NCT06268704 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of New Mexico |
| Condition | Sacroiliac Joint Dysfunction |
| Study Type | INTERVENTIONAL |
| Enrollment | 230 participants |
| Start Date | 2024-03-27 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 230 participants in total. It began in 2024-03-27 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will compare two different corticosteroids (dexamethasone and methylprednisolone) for use in sacroiliac joint injections to treat SI joint pain.
Eligibility Criteria
Inclusion Criteria: * Aged \>18, capable of understanding and providing consent in English, capable of complying with the outcome instruments used, capable of attending all planned follow up visits * Unilateral low back/buttocks pain of at least 2 weeks. * Patient reported 7 day average of numeric pain rating score (NPRS) low back/buttocks pain of at least 5/10 at baseline evaluation * Clinical diagnosis of sacroiliac joint pain as diagnosed by a board certified Physiatrist including history of low back/buttocks pain and at least 2 positive physical exam findings (including positive fortin finger sign, pain with palpation of posterior superior iliac spine, positive FABER's test, positive Gaenslan's test, positive sacral distraction, positive thigh thrust, positive lateral compression, positive sacral thrust) * Patient consents to sacroiliac joint corticosteroid injection in a shared decision-making process with the treating physician. * 80% or more relief of index pain within first 5-15 minutes after injection Exclusion Criteria: * Clinical suspicion of alternative process is greater than clinical suspicion of sacroiliac joint pain * Those receiving remuneration for their pain treatment (e.g., disability, worker's compensation). * Those involved in active litigation relevant to their pain. * Those unable to read English and complete the assessment instruments. * Those unable to attend follow up appointments * The patient is incarcerated. * History of prior sacroiliac joint fusion * Progressive lower extremity neurologic deficit (from active radiculopathy, unhealed radiculopathy, or neuromuscular disease) * Sacroiliac joint steroid injection within the prior 12 months * 2 Positive lumbar medial branch blocks within the past 12 months * Radiofrequency ablation of the lumbar spine within the past 12 months * Lumbar facet steroid injections within the past 12 months * Prior epidural steroid injection within the prior 3 months in any location within the spine. * Possible pregnancy or other reason that precludes the use of fluoroscopy. * Allergy to steroid, contrast media, or local anesthetics. * BMI\>40. * Systemic inflammatory arthritis (e.g., rheumatoid arthritis, ankylosing spondylitis, lupus). * Active infection or treatment of infection with antibiotics within the past 7 days. * Medical conditions causing significant functional disability (e.g., stroke, decompensated ---COPD, decompensated heart failure) * Chronic widespread pain or somatoform disorder (e.g. fibromyalgia). * Addictive behavior, severe clinical depression, or psychotic features.
Contact & Investigator
Reza Ehsanian, MD, PhD
PRINCIPAL INVESTIGATOR
University of New Mexico Department of Anesthesiology and Critical Care
Frequently Asked Questions
Who can join the NCT06268704 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Sacroiliac Joint Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06268704 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06268704 currently recruiting?
Yes, NCT06268704 is actively recruiting participants. Contact the research team at mwshilling@salud.unm.edu for enrollment information.
Where is the NCT06268704 trial being conducted?
This trial is being conducted at Albuquerque, United States.
Who is sponsoring the NCT06268704 clinical trial?
NCT06268704 is sponsored by University of New Mexico. The principal investigator is Reza Ehsanian, MD, PhD at University of New Mexico Department of Anesthesiology and Critical Care. The trial plans to enroll 230 participants.