Clinical trial NCT03122119
Conditions: Chronic Low Back Pain Sacroiliitis Sacroiliac; Backache Platelet Rich Plasma Platelet Injection Site Ultrasound Therapy; Complications Treatment
Keywords: Sacroiliac Joint Injection Platelet Rich Plasma Ultrasound Low Back Pain
Sponsor: Star Spine and Sport
Start date: 2017-05-01; Completion date: 2022-09-01
Enrollment: 51 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This prospective study will be quantitatively analyzing the effectiveness of platelet-rich-plasma (PRP) injections into the sacroiliac (SI) joint in relieving sacroiliitis and low back pain originating from the SI joint. The effectiveness of PRP injections on joint pain has been well studied in the knee and shoulder. PRP injections are performed on the SI joint commonly, but there is little research documenting their effectiveness when compared to other interventions. This study will be a small pilot study to aid in closing this knowledge gap. Additionally, these injections will be performed under ultrasound guidance. Ultrasound has been proven to be of equal reliability to fluoroscopy and has the advantage of shorter time to administer and no radiation. There will be one arm to this study. The data collected will be compared to existing studies on corticosteroid SI joint injection. The experimental arm consists of the PRP injection. The PRP will be injected into the joint using the exact same technique via physical exam, special tests, and ultrasound guidance as performed in our previous studies. The outcomes will be measured with the Numeric Rating Scale for Pain (NRS) and the Oswestry Disability Index (ODI) prior to the injection, immediately post-injection, 2 weeks, 4 weeks, 3 months, and 6 months post-injection. The investigators 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) and Oswestry Disability Index (ODI)."

Detailed description:
PRP is not just an additional tool for physicians to use, but a potential treatment for underlying joint pathology. PRP is one of the closest treatments that exists for a definitive solution for inflammatory and degenerative joint disease. PRP is currently being used for dysfunction of the shoulder joint, knee joint, sacroiliac joint, facet joints, intervertebral discs, rotator cuff, hamstrings, and others. It has been extensively researched for osteoarthritis, tendon, and ligament injury of the knee, but little research has documented the short or long-term effects on the sacroiliac joint. A brief search on PubMed provides only two articles, one of which is a case study, and neither were performed in the United States. PRP is the future of orthopedics and physical medicine as well as a gateway to curing degenerative and inflammatory joint disease.

Furthermore, the use of ultrasound guided injections has helped increase the success rate because it provides a method for visualizing the path of the needle to a precise location. In recent studies, authors have indicated the use of a curvilinear transducer to be the most successful, as well as injections administered to the lower one third of the sacroiliac joint, to be adequately effective in diagnosing and treating sacroiliac joint pain. Disadvantages surrounding fluoroscopy include inconvenience, cost, radiation, and exposure to contrast media. Arranging the procedure can take extensive time and resources. The procedure can be costly for the patient, especially if it does not produce long-term results, and radiation exposure can have long-term consequences for the patient's health, rendering it a questionable treatment for chronic low back pain. As ultrasound guided and fluoroscopic sacroiliac joint injections present themselves as front-runners for diagnosis and treatment of sacroiliac joint-induced low back pain, the benefits and downsides to both are heavily weighed and compared. The next step moving forward in the treatment of the SI joint is administering PRP injections while utilizing ultrasonography for image guidance. The investigators believe this combination will provide the most immediate and long term benefit to patients as well as fewer risks from medications, corticosteroids, and fewer risks and downsides from fluoroscopy, such as radiation and cost.

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, 6 months post-injection.

Most studies in the past look at short-term and moderate-term results up to approximately six months to one year. Many studies state a limitation to their data is the lack of long-term investigation into pain, disability, and function more than 12 months. This is partly due to losing patients to follow up. Patients whose pain resolved have no reason to return for further evaluation.

The investigators will take measures to avoid study bias and confounding by ensuring patients have been correctly diagnosed with sacroiliitis via special tests and physical examination as well as PMT. Additionally, to avoid confounding, the investigators will not administer PRP injections to patients who have had a corticosteroid injection in the SI joint within the last three months or received significant benefit from a corticosteroid injection. The efficacy of corticosteroids in the joint begin to dwindle starting at approximately three months.

This information will be recorded in each patient's chart as well as an Excel file only accessible to key personnel working on the study. The following data will be recorded form each patient: current pain scale using the NRS and their functionality using the ODI.

Arms: arm 1: Venous blood will be drawn from the patient receiving injection treatment. It will be spun down to form PRP and reinjected back into the SI joint.
Interventions: intervention 1: Platelet Rich Plasma Joint Injection
Intervention descriptions: intervention 1: 30 to 50 milliliters of venous blood will be drawn from the patients arm with a 19 gauge ¾ inch needle using universal precautions. The venous blood will be mixed with 8 milliliters of anticoagulant citrate dextrose solution-A (ACD-A). The anti-coagulated blood will then be centrifuged for 15 minutes at 3200 revolutions per minute in the office centrifuge. This will allow plasma to separate from blood cells. The portion of centrifuged blood deficient in platelets will be extracted and discarded. Once the needle is visualized entering the joint capsule via ultrasound guidance and the physician feels resistance provided by the capsule and ligaments, 3 milliliters of PRP extract will be injected (3 inch, 22 gauge needle) into the sacroiliac joint. The needles will be properly disposed.

Protocol documents:
Prot_SAP_002.pdf: 
  
  
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.