Particulate vs. Non-Particulate Steroid for Sacroiliac Joint Injection

NCT06268704 | Recruiting Phase 4 FDA Drug

• 1 other identifier: UNM HRRC #23-503
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare two different corticosteroids (dexamethasone and methylprednisolone) for use in sacroiliac joint injections to treat SI joint pain.

Conditions

Sacroiliac Joint Dysfunction; Sacro-Iliac Spondylosis

Outcome Measures

Primary Outcomes (1)

• Pain using Numeric Pain Rating Score

  Numeric pain rating score is an 11 point scale (0-10) filled out on a form indicating the degree to which the patient experiences pain to assess efficacy of the injection. In this scale a 0, the minimum score, indicates no pain at all with a 10, the maximum score, being the worst pain imaginable. In this study a 50% or greater reduction in numeric pain rating score is considered a successful outcome while failure to achieve at least a 50% improvement as compared to their numeric pain rating score prior to the procedure is considered a poor outcome.

  3 months

Study Arms (2)

Non-Particulate Steroid

EXPERIMENTAL

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.

Drug: Dexamethasone; Drug: 2% Lidocaine HCl Injection

Particulate Steroid

ACTIVE COMPARATOR

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.

Drug: Methylprednisolone; Drug: 2% Lidocaine HCl Injection

Interventions

Dexamethasone DRUG

This is a non-particulate steroid commonly used to treat SI joint pain.

Also known as: Ozurdex, Maxidex, DexPak

Non-Particulate Steroid

Methylprednisolone DRUG

This is a particulate steroid commonly used to treat SI joint pain.

Also known as: Solu-medrol, Depo-Medrol, Medrol

Particulate Steroid

2% Lidocaine HCl Injection DRUG

Lidocaine is a local anesthetic used in SI joint injection procedures to numb the procedure site and helps to confirm SI joint dysfunction when injected with the steroid medication into the SI joint.

Also known as: Lignocaine, Xylocaine

Non-Particulate Steroid; Particulate Steroid

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• % or more relief of index pain within first 5-15 minutes after injection

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico Hospital

Albuquerque, New Mexico, 87131, United States

RECRUITING

MeSH Terms

Interventions

Dexamethasone; Calcium Dobesilate; Methylprednisolone; Methylprednisolone Hemisuccinate; Methylprednisolone Acetate; Lidocaine

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Prednisolone; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Reza Ehsanian, MD, PhD

  University of New Mexico Department of Anesthesiology and Critical Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark W Shilling, BS

CONTACT

505-925-7599; mwshilling@salud.unm.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor and Vice Chair of Clinical Research

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 20, 2024
• Study Start: March 27, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: November 6, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)