Effectiveness of Ultrasound Guided Platelet Rich Plasma Injections in the Sacroiliac Joint (NCT03122119) | Clinical Trial Compass
CompletedPhase 4
Effectiveness of Ultrasound Guided Platelet Rich Plasma Injections in the Sacroiliac Joint
United States51 participantsStarted 2017-05-01
Plain-language 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)."
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 diso…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Numeric Rating Scale for Pain (NRS)
Timeframe: Change from baseline compared to 6 months post injection
2
Oswestry Disability Index (ODI)
Timeframe: Change from baseline compared to 6 months post injection