RECRUITING

Particulate Vs. Non-Particulate Steroid for Sacroiliac Joint Injection

Conditions

Sacroiliac Joint Dysfunction Sacro-Iliac Spondylosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-03-27

Study Completion:2027-05-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06268704

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Mark W Shilling, BS

CONTACT

505-925-7599

mwshilling@salud.unm.edu

Principal Investigator

Reza Ehsanian, MD, PhD

PRINCIPAL_INVESTIGATOR

University of New Mexico Department of Anesthesiology and Critical Care

Study Locations (Sites)

University of New Mexico Hospital

Albuquerque, New Mexico, 87131

United States

Collaborators and Investigators

Sponsor: University of New Mexico

Reza Ehsanian, MD, PhD, PRINCIPAL_INVESTIGATOR, University of New Mexico Department of Anesthesiology and Critical Care

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-27

Study Completion Date2027-05-01

Study Record Updates

Study Start Date2024-03-27

Study Completion Date2027-05-01

Terms related to this study

Additional Relevant MeSH Terms

Sacroiliac Joint Dysfunction
Sacro-Iliac Spondylosis