Particulate Corticosteroid Versus Non-particulate Corticosteroid for Sacroiliac Joint Injection

Randomized Prospective Study of Particulate Corticosteroid Versus Non-particulate Corticosteroid for Sacroiliac Joint Steroid Injection

Comparing two different corticosteroids (dexamethasone and triamcinolone) for use in sacroiliac joint injections

Study Overview

• Status: Terminated
• Conditions: Sacro-Iliac Spondylosis
• Intervention / Treatment: Drug: Dexamethasone; Drug: Triamcinolone Acetonide

Detailed Description

Patients eligible for a sacroiliac joint injection will be randomized to receive one of two different steroids, dexamethasone or triamcinolone. The response immediately after injection will be assessed to confirm the diagnosis, and then they will be followed for three month to assess the degree of pain relief experienced

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37067
      • Byron Schneider

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexamethasone; dexamethasone injected into the sacroiliac joint	Drug: Dexamethasone; Dexamethasone injection into the sacroiliac joint; Other Names: decadron
Active Comparator: Triamcinolone; triamcinolone injected into the sacroiliac joint	Drug: Triamcinolone Acetonide; Triamcinolone injection into the sacroiliac joint; Other Names: Kenalog

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain using Numeric Pain Rating Score	Numeric pain rating score, 11 point scale (0-10) filled out on a form indicating the degree of relief/discomfort after the injection	3 months

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2017
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: May 16, 2017
• First Submitted That Met QC Criteria: May 24, 2017
• First Posted (Actual): May 25, 2017

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: SCHNEIBJ03152017153735

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No