Treatment for Sacroiliac Joint Pain Using Platelet-rich Plasma (PRP) Versus Steroid/Anesthetic
- Conditions
- Sacroiliac Joint SynovitisLow Back Pain
- Interventions
- Procedure: Sacroiliac intra-articular injection
- Registration Number
- NCT05121961
- Lead Sponsor
- University of Utah
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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).
- SIJ steroid treatment within the prior 6 months.
- Patients with a history of infection currently on antibiotic therapy
- Usage of systemic immunosuppressants
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Platelet-rich Plasma Sacroiliac intra-articular injection Patients will receive an intra-articular injection 3 mL of autologous platelet-rich plasma in the sacroiliac joint. Steroid/Anesthetic Sacroiliac intra-articular injection Patients will receive an intra-articular injection 40 mg Depo-medrol mixed with 2 mL 0.25% bupivicaine in the sacroiliac joint.
- Primary Outcome Measures
Name Time Method Numeric Rating Scale 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.
- Secondary Outcome Measures
Name Time Method Functional testing 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.
Short-Form 12 Survey 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.
Modified Oswestry Disability Questionnaire 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.
Opiate/pain medication usage questionnaire 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
Trial Locations
- Locations (2)
University of Utah
🇺🇸Salt Lake City, Utah, United States
Veterans Administration Salt Lake City Health Care System
🇺🇸Salt Lake City, Utah, United States