Clinical Trial: Effectiveness of Ultrasound Guided Platelet Rich Plasma Injections in the Sacroiliac Joint

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Effectiveness of Ultrasound Guided Platelet Rich Plasma Injections in the Sacroiliac Joint to Relieve Low Back Pain

Brief Summary: This prospective study will be quantitatively analyzing the effectiveness of platelet-rich-plasma (PRP) injections into the sacroiliac (SI) joint as compared to corticosteroid injections and conservative management 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 three arms to this study. The first will be a control arm, the second will be an active comparator arm which is the corticosteroid injection, and the third is the experimental arm consisting of PRP injection. The corticosteroid and PRP will be injected into the joint using the exact same technique via physical exam, special tests, and ultrasound guidance. The only difference between the two arms is the substance to be injected. 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, 6 months, 9 months, and 1 year 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 Summary:

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 ben
Sponsor: Star Spine and Sport

Current Primary Outcome:

  • Numeric Rating Scale for Pain (NRS) [ Time Frame: Baseline, change from baseline immediately post injection, and change from baseline at 2 weeks, 4 weeks, 3 months, 6 months, 9 months, and 1 year post-injection ]
    Defined as a numeric scale for pain from 1 to 10. 1 demonstrates minimal pain and 10 demonstrates severe pain or significant impact on activities of daily living.
  • Oswestry Disability Index (ODI) [ Time Frame: Baseline, change from baseline immediately post injection, and change from baseline at 2 weeks, 4 weeks, 3 months, 6 months, 9 months, and 1 year post-injection ]
    Standardized questionnaire which asks 10 questions to assess impact on activities of daily living.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Star Spine and Sport

Dates:
Date Received: April 16, 2017
Date Started: April 1, 2017
Date Completion: March 2020
Last Updated: April 19, 2017
Last Verified: April 2017