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

Primary Purpose

Low Back Pain, Sacroiliac Joint Synovitis

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Sacroiliac intra-articular injection

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of UtahRecruiting
Veterans Administration Salt Lake City Health Care SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Platelet-rich Plasma

Steroid/Anesthetic

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Modified Oswestry Disability Questionnaire

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.

Short-Form 12 Survey

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.

Functional testing

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.

Opiate/pain medication usage questionnaire

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

Full Information

NCT ID

NCT05121961

First Posted

October 20, 2021

Last Updated

October 17, 2023

Sponsor

University of Utah

Collaborators

Radiological Society of North America

1. Study Identification

Unique Protocol Identification Number

NCT05121961

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 22, 2020 (Actual)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Utah

Collaborators

Radiological Society of North America

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain, Sacroiliac Joint Synovitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Single-blind randomized controlled trial

Masking

Participant

Masking Description

Patients will be blinded to which injectate they received.

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Platelet-rich Plasma

Arm Type

Experimental

Arm Description

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

Arm Title

Steroid/Anesthetic

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Sacroiliac intra-articular injection

Intervention Description

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

Primary Outcome Measure Information:

Title

Numeric Rating Scale

Description

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.

Time Frame

Change between baseline and 3-months post-intervention

Secondary Outcome Measure Information:

Title

Modified Oswestry Disability Questionnaire

Description

Time Frame

Change between baseline and 3-months post-intervention

Title

Short-Form 12 Survey

Description

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.

Time Frame

Change between baseline and 3-months post-intervention

Title

Functional testing

Description

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.

Time Frame

Change between baseline and 3-months post-intervention

Title

Opiate/pain medication usage questionnaire

Description

Time Frame

Change between baseline and 3-months post-intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mariya A Chadovich

Phone

801-916-0582

Mariya.Chadovich@hsc.utah.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Suyi Niu

Phone

801-585-1021

Suyi.Niu@hsc.utah.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Miriam Peckham, MD

Organizational Affiliation

University of Utah

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Utah

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mariya Chadovich

Phone

801-916-0582

Mariya.Chadovich@hsc.utah.edu

First Name & Middle Initial & Last Name & Degree

Suyi Niu

Phone

801-585-1021

Suyi.Niu@hsc.utah.edu

First Name & Middle Initial & Last Name & Degree

Miriam Peckham, MD

First Name & Middle Initial & Last Name & Degree

Zachary McCormick, MD

First Name & Middle Initial & Last Name & Degree

Lubdha Shah, MD

First Name & Middle Initial & Last Name & Degree

Troy Hutchins, MD

First Name & Middle Initial & Last Name & Degree

Yoshimi Anzai, MD

Facility Name

Veterans Administration Salt Lake City Health Care System

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84148

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mariya Chadovich

Phone

801-916-0582

Mariya.Chadovich@hsc.utah.edu

First Name & Middle Initial & Last Name & Degree

Suyi Niu

Phone

801-585-1021

Suyi.Niu@hsc.utah.edu

First Name & Middle Initial & Last Name & Degree

Miriam Peckham, MD

First Name & Middle Initial & Last Name & Degree

Lubdha Shah, MD

First Name & Middle Initial & Last Name & Degree

Troy Hutchins, MD

First Name & Middle Initial & Last Name & Degree

Yoshimi Anzai, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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