Effectiveness of Ultrasound Guided Platelet Rich Plasma Injections in the Sacroiliac Joint
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|ClinicalTrials.gov Identifier: NCT03122119|
Recruitment Status : Active, not recruiting
First Posted : April 20, 2017
Last Update Posted : September 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Low Back Pain Sacroiliitis Sacroiliac; Backache Platelet Rich Plasma Platelet Injection Site Ultrasound Therapy; Complications Treatment||Drug: Platelet Rich Plasma Joint Injection||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of Ultrasound Guided Platelet Rich Plasma Injections in the Sacroiliac Joint to Relieve Low Back Pain|
|Actual Study Start Date :||May 1, 2017|
|Estimated Primary Completion Date :||March 1, 2020|
|Estimated Study Completion Date :||September 1, 2020|
Experimental: Platelet Rich Plasma Joint Injection
Venous blood will be drawn from the patient receiving injection treatment. It will be spun down to form PRP and reinjected back into the SI joint.
Drug: Platelet Rich Plasma Joint Injection
30 to 50 milliliters of venous blood will be drawn from the patients arm with a 19 gauge ¾ inch needle using universal precautions. The venous blood will be mixed with 8 milliliters of anticoagulant citrate dextrose solution-A (ACD-A). The anti-coagulated blood will then be centrifuged for 15 minutes at 3200 revolutions per minute in the office centrifuge. This will allow plasma to separate from blood cells. The portion of centrifuged blood deficient in platelets will be extracted and discarded. Once the needle is visualized entering the joint capsule via ultrasound guidance and the physician feels resistance provided by the capsule and ligaments, 3 milliliters of PRP extract will be injected (3 inch, 22 gauge needle) into the sacroiliac joint. The needles will be properly disposed.
- Numeric Rating Scale for Pain (NRS) [ Time Frame: Baseline, change from baseline immediately post injection, and change from baseline at 2 weeks, 4 weeks, 3 months, 6 months, 9 months, and 1 year post-injection ]Defined as a numeric scale for pain from 1 to 10. 1 demonstrates minimal pain and 10 demonstrates severe pain or significant impact on activities of daily living.
- Oswestry Disability Index (ODI) [ Time Frame: Baseline, change from baseline immediately post injection, and change from baseline at 2 weeks, 4 weeks, 3 months, 6 months, 9 months, and 1 year post-injection ]Standardized questionnaire which asks 10 questions to assess impact on activities of daily living.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03122119
|United States, Colorado|
|Star Spine and Sport|
|Golden, Colorado, United States, 80401|
|Principal Investigator:||Douglas Hemler, MD||Star Spine and Sport, Rocky Vista University College of Osteopathic Medicine|