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Particulate Corticosteroid Versus Non-particulate Corticosteroid for Sacroiliac Joint Injection

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 99 Years
Gender All
More 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03166761
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Vanderbilt University Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Byron Schneider
Principal Investigator Affiliation Assistant professor
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Sacro-Iliac Spondylosis
Additional Details

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

Arms & Interventions

Arms

Experimental: Dexamethasone

dexamethasone injected into the sacroiliac joint

Active Comparator: Triamcinolone

triamcinolone injected into the sacroiliac joint

Interventions

Drug: - Dexamethasone

Dexamethasone injection into the sacroiliac joint

Drug: - Triamcinolone Acetonide

Triamcinolone injection into the sacroiliac joint

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Byron Schneider, Nashville, Tennessee

Status

Address

Byron Schneider

Nashville, Tennessee, 37067

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