Platelet-rich Plasma in the Sacroiliac Joint
- Conditions
- Sacroiliac Joint Arthritis
- Interventions
- Procedure: PRPProcedure: Steroid Injection
- Registration Number
- NCT03744234
- Lead Sponsor
- Columbia University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Aged 18 years and older
- Sacroiliac/Lower back pain
- Positive block
- Eligible for steroid injection
- Positive physical manual assessments
- Steroid allergy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Platelet-Rich Plasma Injection PRP Autologous injection of platelet-rich plasma (PRP) in the sacroiliac joint Steroid Injection Steroid Injection Steroid injection in the sacroiliac joint
- Primary Outcome Measures
Name Time Method Change in Score on the Oswestry Low Back Pain Disability Questionnaire Up to 6 months 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.
Change in Visual Analogue Pain (VAS) Score Up to 6 months 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Columbia University Irving Medical Center
🇺🇸New York, New York, United States