Treatment for Sacroiliac Joint Pain Using Platelet-rich Plasma (PRP) Versus Steroid/Anesthetic
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Platelet-rich Plasma Patients will receive an intra-articular injection 3 mL of autologous platelet-rich plasma in the sacroiliac joint. |
Procedure: Sacroiliac intra-articular injection
CT guided injection of platelet-rich plasma versus steroid/anesthetic into the sacroiliac joint
|
| Active Comparator: Steroid/Anesthetic 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
CT guided injection of platelet-rich plasma versus steroid/anesthetic into the sacroiliac joint
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
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
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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).
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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:
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SIJ steroid treatment within the prior 6 months.
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Patients with a history of infection currently on antibiotic therapy
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Usage of systemic immunosuppressants
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Pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Utah | Salt Lake City | Utah | United States | 84132 |
| 2 | Veterans Administration Salt Lake City Health Care System | Salt Lake City | Utah | United States | 84148 |
Sponsors and Collaborators
- University of Utah
- Radiological Society of North America
Investigators
- Principal Investigator: Miriam Peckham, MD, University of Utah
Study Documents (Full-Text)
More Information
Publications
None provided.- RSCH1923