Particulate Corticosteroid Versus Non-particulate Corticosteroid for Sacroiliac Joint Injection

Vanderbilt University Medical Center

Status and phase

Terminated

Phase 4

Conditions

Sacro-Iliac Spondylosis

Treatments

Drug: Triamcinolone Acetonide

Drug: Dexamethasone

Study type

Interventional

Funder types

Other

Identifiers

NCT03166761

SCHNEIBJ03152017153735

Details and patient eligibility

About

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

Full 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

Enrollment

41 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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.