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

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05121961
• Other study ID #: RSCH1923
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: University of Utah
• Contact: Mariya A Chadovich
• Phone: 801-916-0582
• Email: Mariya.Chadovich[@]hsc.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• Low Back Pain
• Synovitis

Intervention

Procedure:
• Sacroiliac intra-articular injection
CT guided injection of platelet-rich plasma versus steroid/anesthetic into the sacroiliac joint

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah
United States	Veterans Administration Salt Lake City Health Care System	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Radiological Society of North America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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