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
Intervention: Platelet Rich Plasma Joint Injection
Intervention description: 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.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Sacroiliac; Joint Injection; Platelet Rich Plasma; Ultrasound; Low Back Pain

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)."
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of sacroiliitis

          -  Age 18 to 80 years old

          -  Chronic low back pain

          -  SI joint pathology is the predominant source of pain

          -  Positive Fortin Finger Test (PMT)

          -  Joint anatomy is identifiable using ultrasonography

          -  Patient has no other comorbidities that contraindicate the procedure

          -  Patient has attempted physical therapy and corticosteroid injections with local
             anesthetic -Previous injections of lidocaine and corticosteroid provided at least
             minor immediate relief

          -  Patient must not have had a corticosteroid injection in the SI joint within the last
             three months

          -  Patient must consent to the procedure

        Exclusion Criteria:

          -  Patients under the age of 18 (Subjects under the age of 18 will not be included in
             this study due to the continued growth and development of their joints and unstudied
             effects on children.)

          -  Over the age of 80

          -  Multiple pain sources and multifactorial pain sources that complicated or confound
             diagnosing the SI joint as the primary and predominant pain generator that may
             contribute to low back pain (including but not limited to: lumbar diagnosis, lumbar
             radiculopathy, intra or extra-articular hip pathology to include acetabulum and
             femoral head, lumbo-sacral joint pathology, intervertebral disk disease,
             spondylolisthesis/spondylosis/spondylolysis of lumbar vertebra)

          -  Immunosuppressed/immune compromised

          -  Underlying comorbidities that contraindicate the procedure (including but not limited
             to polycythemia, coagulation disorder, or malignancy).