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Platelet-rich Plasma in the Sacroiliac Joint

Not Applicable
Completed
Conditions
Sacroiliac Joint Arthritis
Interventions
Procedure: PRP
Procedure: 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
Inclusion Criteria
  • Aged 18 years and older
  • Sacroiliac/Lower back pain
  • Positive block
  • Eligible for steroid injection
  • Positive physical manual assessments
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Exclusion Criteria
  • Steroid allergy
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Platelet-Rich Plasma InjectionPRPAutologous injection of platelet-rich plasma (PRP) in the sacroiliac joint
Steroid InjectionSteroid InjectionSteroid injection in the sacroiliac joint
Primary Outcome Measures
NameTimeMethod
Change in Score on the Oswestry Low Back Pain Disability QuestionnaireUp 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) ScoreUp 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
NameTimeMethod

Trial Locations

Locations (1)

Columbia University Irving Medical Center

🇺🇸

New York, New York, United States

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