Particulate Corticosteroid Versus Non-particulate Corticosteroid for Sacroiliac Joint Injection

NCT03166761 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: SCHNEIBJ03152017153735
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sacro-Iliac Spondylosis

Outcome Measures

Primary Outcomes (1)

• 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. Pain was assessed monthly from baseline to 3 months following the injection. The average value at month 3 is reported.

  Baseline to 3 months; Average value at month 3 reported

Study Arms (2)

Dexamethasone

EXPERIMENTAL

dexamethasone injected into the sacroiliac joint

Drug: Dexamethasone

Triamcinolone

ACTIVE COMPARATOR

triamcinolone injected into the sacroiliac joint

Drug: Triamcinolone Acetonide

Interventions

Dexamethasone DRUG

Dexamethasone injection into the sacroiliac joint

Also known as: decadron

Dexamethasone

Triamcinolone Acetonide DRUG

Triamcinolone injection into the sacroiliac joint

Also known as: Kenalog

Triamcinolone

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• % or more relief of index pain within first 5-15 minutes after injection

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Byron Schneider

Nashville, Tennessee, 37067, United States

Location

MeSH Terms

Interventions

Dexamethasone; Calcium Dobesilate; Triamcinolone Acetonide

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Triamcinolone

Results Point of Contact

• Title: Byron Schneider
• Organization: Vanderbilt University Medical Center

byron.j.schneider@vumc.org

(615)936-7708

Study Officials

• Byron Schneider

  Assistant professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 25, 2017
• Study Start: September 14, 2017
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: July 10, 2024
• Results First Posted: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)