Comparing two types of steroids for sacroiliac joint injections
Particulate Versus Non-Particulate Corticosteroid in Sacroiliac Joint Injection: A Randomized Prospective Study
This study is testing which of two steroids, dexamethasone or methylprednisolone, works better to relieve pain for people with sacroiliac joint issues after receiving injections.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 230 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of New Mexico Academic / other |
| Locations | 1 site (Albuquerque, New Mexico) |
| Trial ID | NCT06268704 on ClinicalTrials.gov |
What this trial studies
This study compares the efficacy and safety of two corticosteroids, dexamethasone and methylprednisolone, in treating sacroiliac joint pain through injections. Patients will be randomly assigned to receive one of the two medications and will report their pain levels immediately after the procedure. They will be monitored for three months to assess the outcomes of pain relief and any potential side effects. The goal is to determine which steroid provides better relief for patients suffering from sacroiliac joint dysfunction.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with unilateral low back or buttocks pain lasting at least two weeks and a significant pain rating.
Not a fit: Patients with conditions unrelated to sacroiliac joint dysfunction or those who cannot comply with the study requirements may not benefit.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for patients with sacroiliac joint pain.
How similar studies have performed: Other studies have explored corticosteroid injections for joint pain, but this specific comparison of dexamethasone and methylprednisolone is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Albuquerque, New Mexico
- University of New Mexico Hospital — Albuquerque, New Mexico, United States (Recruiting)
Study contacts
- Principal investigator: Reza Ehsanian, MD, PhD — University of New Mexico Department of Anesthesiology and Critical Care
- Study coordinator: Mark W Shilling, BS
- Email: mwshilling@salud.unm.edu
- Phone: 505-925-7599
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.