NCT05121961

Brief Summary

The purpose of this study is to determine if platelet-rich plasma is superior to steroid/anesthetic for the treatment of sacroiliac joint pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2020

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 16, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

5.4 years

First QC Date

October 20, 2021

Last Update Submit

April 13, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Numeric Rating Scale

    Validated pain scale rating pain on a scale of 0 through 10. 0 for no pain, and 10 for the highest pain the patient can imagine.

    Change between baseline and 3-months post-intervention

Secondary Outcomes (4)

  • Modified Oswestry Disability Questionnaire

    Change between baseline and 3-months post-intervention

  • Short-Form 12 Survey

    Change between baseline and 3-months post-intervention

  • Functional testing

    Change between baseline and 3-months post-intervention

  • Opiate/pain medication usage questionnaire

    Change between baseline and 3-months post-intervention

Study Arms (2)

Platelet-rich Plasma

EXPERIMENTAL

Patients will receive an intra-articular injection 3 mL of autologous platelet-rich plasma in the sacroiliac joint.

Procedure: Sacroiliac intra-articular injection

Steroid/Anesthetic

ACTIVE COMPARATOR

Patients will receive an intra-articular injection 40 mg Depo-medrol mixed with 2 mL 0.25% bupivicaine in the sacroiliac joint.

Procedure: Sacroiliac intra-articular injection

Interventions

CT guided injection of platelet-rich plasma versus steroid/anesthetic into the sacroiliac joint

Platelet-rich PlasmaSteroid/Anesthetic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (\>18 y/o) males and females referred for therapeutic injection to the investigators spine interventional service by a physiatrist or pain anesthesiologist with a clinical diagnosis of SIJ pain confirmed by history
  • % or greater reduction in pain by a diagnostic anesthetic block using no more than 1.5 cc 2% lidocaine performed under imaging guidance by a pain interventionalist (PM\&R, Pain Anesthesia, or Neuroradiology Spine Intervention).
  • Baseline pain must be \>/=4 by numeric rating scale (NRS), at least 6 weeks in chronicity, and must not be multi-factorial (related to radiculopathy or axial pain localizing elsewhere) by physical examination or confounding medical history (infection, inflammatory spondyloarthropathy, or osseous metastatic disease).

You may not qualify if:

  • SIJ steroid treatment within the prior 6 months.
  • Patients with a history of infection currently on antibiotic therapy
  • Usage of systemic immunosuppressants
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Veterans Administration Salt Lake City Health Care System

Salt Lake City, Utah, 84148, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Miriam Peckham, MD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients will be blinded to which injectate they received.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single-blind randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 20, 2021

First Posted

November 16, 2021

Study Start

February 22, 2020

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations