Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06268704

Particulate vs. Non-Particulate Steroid for Sacroiliac Joint Injection

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of New Mexico Hospital

Albuquerque, New Mexico, 87131, United States

Location status: Recruiting

Location contact

Mark W Shilling, BS

CONTACT

[email protected]

505-925-7599

About this study

Patients who are screened for inclusion will be randomized into one of two groups; dexamethasone or methylprednisolone. Patients will report their pain immediately after the procedure to confirm the diagnosis of sacroiliac joint pain, then be followed for three months to compare the efficacy and safety of the two medications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexamethasone

Drug

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

Other names: Ozurdex, Maxidex, DexPak

methylprednisolone

Drug

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

Other names: Solu-medrol, Depo-Medrol, Medrol

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.

Other names: Lignocaine, Xylocaine

Primary outcomes

  1. Pain using Numeric Pain Rating Score

    Time frame: 3 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mark W Shilling, BS

CONTACT

[email protected]

505-925-7599

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Registry information

Official study title

Particulate Versus Non-Particulate Corticosteroid in Sacroiliac Joint Injection: A Randomized Prospective Study

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 20, 2024
Registry last updated
Nov 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.