Clinical trial NCT03166761: Particulate Corticosteroid Versus Non-particulate Corticosteroid for Sacroiliac Joint Injection
Official title: Randomized Prospective Study of Particulate Corticosteroid Versus Non-particulate Corticosteroid for Sacroiliac Joint Steroid Injection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Sacro-Iliac Spondylosis
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2017-05-25
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility 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.

Primary outcomes:
measure: Pain Using Numeric Pain Rating Score
timeFrame: Baseline to 3 months; Average value at month 3 reported
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Byron Schneider
state: Tennessee
Study officials:
affiliation: Assistant professor
name: Byron Schneider
role: PRINCIPAL_INVESTIGATOR
References: