Effectiveness of Ultrasound Guided Platelet Rich Plasma Injections in the Sacroiliac Joint
Condition: Chronic Low Back Pain; Sacroiliitis; Sacroiliac; Backache; Platelet Rich Plasma; Platelet; Injection Site; Ultrasound Therapy; Complications; Treatment
MeSH terms: Sacroiliitis; Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Platelet Rich Plasma Joint Injection
Intervention type(s): Drug
Intervention description(s): 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.
Other intervention name(s): PRP Joint Injection; PRP
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sacroiliac; Joint Injection; Platelet Rich Plasma; Ultrasound; Low Back Pain