Recruiting

Particulate vs. Non-Particulate

Sponsor:

University of New Mexico

Code:

NCT06268704

Conditions

Sacroiliac Joint Dysfunction

Sacro-Iliac Spondylosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Dexamethasone

Methylprednisolone

2% Lidocaine HCl Injection

Study Details

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

Study ID

NCT06268704

Start date

Mar 27, 2024

Status verified date

Nov, 2025

Completion date

May 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

230 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Non-Particulate Steroid

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.

active comparator: Particulate Steroid

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.

Interventions

Dexamethasone

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

Methylprednisolone

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

2% Lidocaine HCl Injection

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.

Primary outcome measure

  • Pain using Numeric Pain Rating Score [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Mark W Shilling, BS

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

Locations

University of New Mexico Hospital

Recruiting

Albuquerque, New Mexico, United States, 87131

Contacts

Mark W Shilling, BS

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

More Information

Sponsor

University of New Mexico

Last update posted

Nov 6, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of New Mexico on 2025-11-06.