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Completed

NCT Number: NCT03744234

Platelet-rich Plasma in the Sacroiliac Joint

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.

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Key information

Conditions

Sacroiliac Joint Arthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases Sacroiliitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRP

Procedure

Autologous platelet-rich plasma

Steroid injection

Procedure

Steroid injection

Primary outcomes

  1. Change in Visual Analogue Pain (VAS) Score

    Time frame: 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.

  2. Change in Score on the Oswestry Low Back Pain Disability Questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 16, 2018
Registry last updated
Sep 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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