Effectiveness of Ultrasound Guided Platelet Rich Plasma Injections in the Sacroiliac Joint to Relieve Low Back Pain
Phase: PHASE4
Conditions: Chronic Low Back Pain, Sacroiliitis, Sacroiliac; Backache, Platelet Rich Plasma, Platelet, Injection Site, Ultrasound Therapy; Complications, Treatment
Sponsor: Star Spine and Sport

  
  
Effectiveness of Ultrasound Guided Platelet Rich Plasma Injections in the Sacroiliac Joint 
NCT03122119  
April 25, 2023 
  
  
 

  
Protocol Synopsis for Research Project Involving Human Subjects  
  
PROTOCOL INFORMTION  
  
Title of Research Activity: Effectiveness of Ultrasound Guided Platelet Rich Plasma Injections in 
the Sacroiliac Joint  
  
A. Specific Aims  
The objective of this research is to identify the effectiveness of Platelet-Rich Plasma (PRP) 
injections into the sacroiliac (SI) joint in relieving low back pain.  
  
B. Experimental Design and Methods  
The research design for this study will be a prospective clinical trial evaluating the improvement 
in low back pain secondary to SI joint dysfunction pre and post PRP injection. No control group 
will be utilized in our study due to the ethics of research in withholding treatment to patients. 
Patients who are found to be candidates will be offered the PRP injection without cost until the 
number of available donated kits is exceeded. Each subject will serve as their own control by 
reporting pre-injection pain levels as well as pain levels immediately post-injection, 2 weeks, 4 
weeks, 3 months, and 6 months post-injection.  
  
Our hypothesis is, “Platelet-Rich Plasma Injections in the Sacroiliac Joint using ultrasonography 
in conjunction with physical examination and Point of Maximal Tenderness will produce 
statistically significant pain relief for more than 3 months as measured by the Numeric Rating 
Scale for Pain (NRS).”  
  
Experimental design will be a nonrandomized trial (or quasi-experiment). The specific study 
design to be used is pretest-posttest design. The independent variable will be the PRP injection. 
The dependent variables of interest include the NRS and Oswestry Disability Index (ODI) 
recording pre-injection, immediately post-injection, 2 weeks, 4 weeks, 3 months, and 6 months, 
post-injection.  
  
1) Methods and Procedures  
Data in this study will be collected quantitatively by assessing the patient’s pain prior to the 
injection as well as at 2 weeks, 4 weeks, 3 months, and 6 month follow up using the NRS and 
ODI.  
  
2) Data Analysis and Data Monitoring  
The following data will be recorded from each patient: current pain scale using the NRS and 
their functionality using the ODI.  
  
Study Protocol   
  

  
Summary  
 We would like to analyze and obtain confidence intervals and mean reduction of NRS and ODI 
for the following:  
Confidence Interval for the following (for both NRS and ODI):  
1. Baseline – 2wks  
2. Baseline – 4wks  
3. Baseline – 3 months  
4. Baseline – 6 months  
  
Statistical Analysis Plan  
The Oswestry Disability Index (ODI) uses a questionnaire to assess pain levels and the impact pain has 
on a patient’s daily life. This was chosen as the primary outcome measure and was calculated based on 
a questionnaire then converted to a percentage for objective comparison.    
  
The secondary outcome measure was the Numeric Rating Scale for Pain (NRS). This rating scale provided 
another objective tool based purely on pain severity for comparison of changes in pain levels pre- and 
post-injection.   
  
Statistical analysis was performed using SPSS 25, XLStat 2019.1.2, and R3.5.2. Variables were assessed 
for normality of distribution by using the Shapiro-Wilk test and Jarque-Bera test. ODI and NRS scores 
were compared from baseline to 2 weeks, 4 weeks, 3 months, and 6 months using ANOVA and paired 
ttest. Discrete variables were summarized as means and standard deviations.