Clinical trial NCT05121961: Treatment for Sacroiliac Joint Pain Using Platelet-rich Plasma (PRP) Versus Steroid/Anesthetic
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Sacroiliac Joint Synovitis
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Radiological Society of North America
First posted: 2021-11-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind randomized controlled trial
Primary purpose: TREATMENT

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).

Eligibility 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
* 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

Primary outcomes:
measure: Numeric Rating Scale
timeFrame: Change between baseline and 3-months post-intervention
Secondary outcomes:
measure: Modified Oswestry Disability Questionnaire
timeFrame: Change between baseline and 3-months post-intervention
measure: Short-Form 12 Survey
timeFrame: Change between baseline and 3-months post-intervention
measure: Functional testing
timeFrame: Change between baseline and 3-months post-intervention
measure: Opiate/pain medication usage questionnaire
timeFrame: Change between baseline and 3-months post-intervention
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Salt Lake City
country: United States
facility: Veterans Administration Salt Lake City Health Care System
state: Utah
Study officials:
affiliation: University of Utah
name: Miriam Peckham, MD
role: PRINCIPAL_INVESTIGATOR
References: