Treatment for Sacroiliac Joint Pain Using Platelet-rich Plasma (PRP) Versus Steroid/Anesthetic

March 4, 2024 updated by: Miriam Peckham, University of Utah

Treatment for Sacroiliac Joint Pain Using Platelet-rich Plasma (PRP) Regenerative Therapy: A Randomized Controlled Trial in Comparison With Steroid/Anesthetic Injection With Advanced MR Analysis

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

All patients with sacroiliac joint pain diagnosed by a back pain specialist will undergo physical examination maneuvers and a test lidocaine injection of the joint. Patients who meet eligibility requirements will be randomized in a single-blind randomized controlled manner with a 50% chance of receiving platelet-rich plasma versus steroid/anesthetic injection of the sacroiliac joint(s).

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • University of Utah
        • Contact:
        • Principal Investigator:
          • Miriam Peckham, MD
        • Sub-Investigator:
          • Zachary McCormick, MD
        • Sub-Investigator:
          • Lubdha Shah, MD
        • Sub-Investigator:
          • Troy Hutchins, MD
        • Sub-Investigator:
          • Yoshimi Anzai, MD
        • Contact:
      • Salt Lake City, Utah, United States, 84148
        • Recruiting
        • Veterans Administration Salt Lake City Health Care System
        • Contact:
        • Principal Investigator:
          • Miriam Peckham, MD
        • Sub-Investigator:
          • Lubdha Shah, MD
        • Sub-Investigator:
          • Troy Hutchins, MD
        • Sub-Investigator:
          • Yoshimi Anzai, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • 50% 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).

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Platelet-rich Plasma
Patients will receive an intra-articular injection 3 mL of autologous platelet-rich plasma in the sacroiliac joint.
Procedure: Sacroiliac intra-articular injection
CT guided injection of platelet-rich plasma versus steroid/anesthetic into the sacroiliac joint
Active Comparator: Steroid/Anesthetic
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
CT guided injection of platelet-rich plasma versus steroid/anesthetic into the sacroiliac joint

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Rating Scale
Time Frame: Change between baseline and 3-months post-intervention
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Oswestry Disability Questionnaire
Time Frame: Change between baseline and 3-months post-intervention
Validated questionnaire used to evaluate function in patients with low back pain. The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.
Change between baseline and 3-months post-intervention
Short-Form 12 Survey
Time Frame: Change between baseline and 3-months post-intervention
Validated survey used to evaluate function in patients with low back pain. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Change between baseline and 3-months post-intervention
Functional testing
Time Frame: Change between baseline and 3-months post-intervention
2 validated tests for low back pain "get up and go," "5 time sit to stand." Shorter times indicate better physical function, and longer times indicate poorer physical function.
Change between baseline and 3-months post-intervention
Opiate/pain medication usage questionnaire
Time Frame: Change between baseline and 3-months post-intervention
Questionnaire on type, dose, and frequency of pain medications being used by the patient. All opiates will be converted to the morphine milligram equivalent scale with lower values indicating lower opiate content and higher values indicating higher opiate content
Change between baseline and 3-months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

Radiological Society of North America

Investigators

  • Principal Investigator: Miriam Peckham, MD, University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2020

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

October 20, 2021

First Submitted That Met QC Criteria

November 3, 2021

First Posted (Actual)

November 16, 2021

Study Record Updates

Last Update Posted (Actual)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSCH1923

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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