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Corticosteroid

Steroid Injections for Sacroiliac Joint Dysfunction

Phase 4
Recruiting
Led By Reza Ehsanian, MD, PhD
Research Sponsored by University of New Mexico
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial

Summary

"This trial will compare two types of corticosteroids (dexamethasone and methylprednisolone) to see which one is more effective in relieving pain in the sacroili

Who is the study for?
This trial is for adults over 18 with unilateral low back or buttocks pain lasting at least two weeks, and a pain score of at least 5/10. They must have been diagnosed with sacroiliac joint pain by a specialist and shown significant improvement after an initial injection. Participants need to understand English, consent to treatment, and be able to attend follow-ups.
What is being tested?
The study compares the effectiveness of two corticosteroids—dexamethasone and methylprednisolone—injected into the sacroiliac joint for relieving SI joint pain. It also involves an initial numbing agent (2% Lidocaine) during the procedure.
What are the potential side effects?
Possible side effects include temporary increase in pain, changes in blood sugar levels for diabetics, facial flushing, insomnia, anxiety, menstrual changes in women, and rare instances of infection or allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain using Numeric Pain Rating Score

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Non-Particulate SteroidExperimental Treatment2 Interventions
Patients in this arm will receive an injection of 1 milliliter of 2% lidocaine with 10 milligrams of dexamethasone to one or both sacroiliac joints. If participants initially achieve relief from the injection but then have a return of pain they may be offered a second injection with the same drug at the same dose.
Group II: Particulate SteroidActive Control2 Interventions
Patients in this arm will receive an injection of 1 milliliter of 2% lidocaine with 40 milligrams of methylprednisolone to one or both sacroiliac joints. If participants initially achieve relief from the injection but then have a return of pain they may be offered a second injection with the same drug at the same dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2650

Find a Location

Who is running the clinical trial?

University of New MexicoLead Sponsor
384 Previous Clinical Trials
3,525,726 Total Patients Enrolled
Reza Ehsanian, MD, PhDPrincipal InvestigatorUniversity of New Mexico Department of Anesthesiology and Critical Care
~153 spots leftby Jan 2027
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