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Particulate Corticosteroid Versus Non-particulate Corticosteroid for Sacroiliac Joint Injection

Primary Purpose

Sacro-Iliac Spondylosis

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Triamcinolone Acetonide
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sacro-Iliac Spondylosis

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Byron Schneider

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dexamethasone

Triamcinolone

Arm Description

dexamethasone injected into the sacroiliac joint

triamcinolone injected into the sacroiliac joint

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 16, 2017
Last Updated
February 28, 2023
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03166761
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
recruitment and staffing
Study Start Date
September 14, 2017 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sacro-Iliac Spondylosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone
Arm Type
Experimental
Arm Description
dexamethasone injected into the sacroiliac joint
Arm Title
Triamcinolone
Arm Type
Active Comparator
Arm Description
triamcinolone injected into the sacroiliac joint
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
decadron
Intervention Description
Dexamethasone injection into the sacroiliac joint
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide
Other Intervention Name(s)
Kenalog
Intervention Description
Triamcinolone injection into the sacroiliac joint
Primary Outcome Measure Information:
Title
Pain using Numeric Pain Rating Score
Description
Numeric pain rating score, 11 point scale (0-10) filled out on a form indicating the degree of relief/discomfort after the injection
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byron Schneider
Organizational Affiliation
Assistant professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Byron Schneider
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Particulate Corticosteroid Versus Non-particulate Corticosteroid for Sacroiliac Joint Injection

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