Platelet-rich Plasma in the Sacroiliac Joint

Study Overview
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Brief Summary
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This is a double-blinded study where the injecting physicians and the patients will not know which arm they are randomized to. Each participant will be followed up for 6 months following the injection, and will have in office visits at the injection and approximately 2 weeks post injection. They will be called at month 1, 3, and 6 post injection to assess for any adverse events and number of physical therapy hours or changes in medication. At time of injection, 2 weeks post, and 1, 3 and 6 months after they will be asked to answer some questionnaires on pain and function.

Detailed Description
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Sacroiliac joint (SIJ) pain is a common and significant source of chronic low back pain. It has been broadly defined as pain located in the area of the SIJ that can be elicited by various pain provocation tests and relieved after infiltration of the joint with local anesthetic. Essentially, a patients own blood is collected and spun at varying speeds until it separates into 3 layers, one of which is the platelet-rich plasma. Platelet-rich plasma (PRP) injections are commonly used in various conditions including chronic tendinopathy, soft tissue injuries, and ligamentous injuries. More recently, there has been a greater interest in examining the efficacy of PRP as a treatment for musculoskeletal conditions affecting joints, such as osteoarthritis (OA). To the investigators' knowledge, there are currently no reported studies evaluating the efficacy of PRP for SIJ pain. Given the previously discussed application and evidence behind the use of PRP in the knee and hip joints, the investigators propose that PRP can also provide a similar solution for treating SIJ pain.

Official Title
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Platelet-rich Plasma in the Sacroiliac Joint

Conditions
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Sacroiliac Joint Arthritis

Intervention / Treatment
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* Procedure: PRP
* Procedure: Steroid Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 years and older Sacroiliac/Lower back pain Positive block Eligible for steroid injection Positive physical manual assessments Exclusion Criteria: Steroid allergy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet-Rich Plasma Injection<br>Autologous injection of platelet-rich plasma (PRP) in the sacroiliac joint | Procedure: PRP<br>* Autologous platelet-rich plasma<br>|
| Active Comparator: Steroid Injection<br>Steroid injection in the sacroiliac joint | Procedure: Steroid Injection<br>* Steroid injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analogue Pain (VAS) Score | The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. | Up to 6 months | 
| Change in Score on the Oswestry Low Back Pain Disability Questionnaire | The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) allows researchers and disability evaluators to measure a patient's permanent functional disability. For each section the total possible score is 5 (0= no pain to 5=worst pain) and there are 10 sections of questions. An aggregate score (percentage) is then calculated, with 0% indicating no disability to 100%, indicating crippled or bed-bound. | Up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PRP, Platelet-Rich Plasma, Sacroiliac Joint Pain, SIJ Pain, Osteoarthritis