Particulate vs. Non-Particulate Steroid for Sacroiliac Joint Injection

Sacroiliac Joint Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06268704
• Other study ID #: UNM HRRC #23-503
• Status: Recruiting
• Phase: Phase 4
• Start date: March 27, 2024
• Est. completion date: May 1, 2025

Study information

• Verified date: March 2024
• Source: University of New Mexico
• Contact: Mark W Shilling, BS
• Phone: 505-925-7599
• Email: mwshilling[@]salud.unm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: May 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Joint Diseases
• Sacro-Iliac Spondylosis
• Sacroiliac Joint Dysfunction
• Spondylosis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	University of New Mexico Hospital	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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