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Corticosteroid

Non-Particulate Steroid 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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain using Numeric Pain Rating Score

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

~2590

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of New MexicoLead Sponsor

372 Previous Clinical Trials

3,528,559 Total Patients Enrolled

Reza Ehsanian, MD, PhDPrincipal InvestigatorUniversity of New Mexico Department of Anesthesiology and Critical Care

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for individuals to participate in this clinical trial?

"To be considered eligible for this study, candidates must exhibit dysfunction in the sacroiliac joint and fall within an age range of 18 to 99 years old. Approximately 230 individuals are being sought for participation."

Answered by AI

What is the total number of participants being selected for enrollment in this clinical trial?

"Indeed, the details on clinicaltrials.gov highlight that this investigation is currently in search of participants. The trial was originally published on March 27th, 2024 and had its latest update on March 28th, 2024. Enrollment aims to reach a total of 230 individuals from a single designated site."

Answered by AI

Are there any available openings for participants in this ongoing clinical trial?

"According to the details available on clinicaltrials.gov, this study is currently seeking participants. The trial was initially listed on 3/27/2024 and underwent its most recent update on 3/28/2024."

Answered by AI

Is the research study considering individuals younger than 30 years old as participants?

"Individuals aged 18 to 99 years old are eligible for participation in this clinical trial."

Answered by AI

Does the FDA endorse non-particulate corticosteroids for medical use?

"Given that this trial is categorized as Phase 4, indicating the treatment's approval status, our assessment at Power rates the safety of Non-Particulate Steroid as a 3 on our scale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Particulate vs. Non-Particulate Steroid for Sacroiliac Joint Injection

rehsanian 2024. "Particulate vs. Non-Particulate Steroid for Sacroiliac Joint Injection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06268704.

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