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Particulate Corticosteroid Versus Non-particulate Corticosteroid for Sacroiliac Joint Injection

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ClinicalTrials.gov Identifier: NCT03166761
Recruitment Status : Enrolling by invitation
First Posted : May 25, 2017
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
Byron Schneider, Vanderbilt University Medical Center

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

Condition or disease Intervention/treatment Phase
Sacro-Iliac Spondylosis Drug: Dexamethasone Drug: Triamcinolone Acetonide Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Prospective Study of Particulate Corticosteroid Versus Non-particulate Corticosteroid for Sacroiliac Joint Steroid Injection
Actual Study Start Date : September 14, 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020


Arm Intervention/treatment
Experimental: Dexamethasone
dexamethasone injected into the sacroiliac joint
Drug: Dexamethasone
Dexamethasone injection into the sacroiliac joint
Other Name: decadron

Active Comparator: Triamcinolone
triamcinolone injected into the sacroiliac joint
Drug: Triamcinolone Acetonide
Triamcinolone injection into the sacroiliac joint
Other Name: Kenalog




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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03166761


Locations
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United States, Tennessee
Byron Schneider
Nashville, Tennessee, United States, 37067
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Byron Schneider Assistant professor

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Responsible Party: Byron Schneider, Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03166761     History of Changes
Other Study ID Numbers: SCHNEIBJ03152017153735
First Posted: May 25, 2017    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Dexamethasone
Dexamethasone acetate
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
BB 1101
Triamcinolone diacetate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors