Low Back Pain, Sacroiliac Joint Synovitis
Conditions
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).
Interventions
PROCEDURESacroiliac intra-articular injection
CT guided injection of platelet-rich plasma versus steroid/anesthetic into the sacroiliac joint
Sponsors
University of Utah
Radiological Society of North America
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients will be blinded to which injectate they received.
Intervention model description
Single-blind randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMiriam Peckham, MD
University of Utah
Outcome results
None listed