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

Study Overview
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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).

Official Title
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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

Conditions
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Low Back Pain, Sacroiliac Joint Synovitis

Intervention / Treatment
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* Procedure: Sacroiliac intra-articular injection


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-blind randomized controlled trial
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change between baseline and 3-months post-intervention | 
| 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. | Change between baseline and 3-months post-intervention | 
| 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. | Change between baseline and 3-months post-intervention | 
| 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 | Change between baseline and 3-months post-intervention |