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

NCT ID: NCT05121961

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-22

Study Completion Date

2025-06-30

Brief Summary

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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

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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).

Conditions

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Low Back Pain Sacroiliac Joint Synovitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-blind randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Patients will be blinded to which injectate they received.

Study Groups

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Platelet-rich Plasma

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

Group Type EXPERIMENTAL

Sacroiliac intra-articular injection

Intervention Type PROCEDURE

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

Steroid/Anesthetic

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

Group Type ACTIVE_COMPARATOR

Sacroiliac intra-articular injection

Intervention Type PROCEDURE

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

Interventions

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Sacroiliac intra-articular injection

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radiological Society of North America

OTHER

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Miriam Peckham

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Miriam Peckham, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

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University of Utah

Salt Lake City, Utah, United States

Site Status RECRUITING

Veterans Administration Salt Lake City Health Care System

Salt Lake City, Utah, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ghazaleh Safazadeh

Role: CONTACT

Phone: 801-585-1021

Email: [email protected]

Suyi Niu

Role: CONTACT

Phone: 801-585-1021

Email: [email protected]

Facility Contacts

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Ghazaleh Safazadeh

Role: primary

Suyi Niu

Role: backup

Ghazaleh Safazadeh

Role: primary

Suyi Niu

Role: backup

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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RSCH1923

Identifier Type: -

Identifier Source: org_study_id