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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03166761
Other study ID # SCHNEIBJ03152017153735
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date September 14, 2017
Est. completion date February 28, 2023

Study information

Verified date February 2023
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Terminated
Enrollment 41
Est. completion date February 28, 2023
Est. primary completion date February 28, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexamethasone
Dexamethasone injection into the sacroiliac joint
Triamcinolone Acetonide
Triamcinolone injection into the sacroiliac joint

Locations

Country Name City State
United States Byron Schneider Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT04446988 - Ultrasound Versus Fluoroscopic Guided Sacroiliac Joint Injection In Patients With Chronic Sacroiliac Joint Pain N/A
Recruiting NCT06268704 - Particulate vs. Non-Particulate Steroid for Sacroiliac Joint Injection Phase 4