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Effectiveness of Ultrasound Guided Platelet Rich Plasma Injections in the Sacroiliac Joint

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03122119
Recruitment Status : Active, not recruiting
First Posted : April 20, 2017
Last Update Posted : September 3, 2019
Sponsor:
Information provided by (Responsible Party):
Douglas Hemler, Star Spine and Sport

Brief Summary:
This prospective study will be quantitatively analyzing the effectiveness of platelet-rich-plasma (PRP) injections into the sacroiliac (SI) joint in relieving sacroiliitis and low back pain originating from the SI joint. The effectiveness of PRP injections on joint pain has been well studied in the knee and shoulder. PRP injections are performed on the SI joint commonly, but there is little research documenting their effectiveness when compared to other interventions. This study will be a small pilot study to aid in closing this knowledge gap. Additionally, these injections will be performed under ultrasound guidance. Ultrasound has been proven to be of equal reliability to fluoroscopy and has the advantage of shorter time to administer and no radiation. There will be one arm to this study. The data collected will be compared to existing studies on corticosteroid SI joint injection. The experimental arm consists of the PRP injection. The PRP will be injected into the joint using the exact same technique via physical exam, special tests, and ultrasound guidance as performed in our previous studies. The outcomes will be measured with the Numeric Rating Scale for Pain (NRS) and the Oswestry Disability Index (ODI) prior to the injection, immediately post-injection, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, and 1 year post-injection. The investigators hypothesis is, "Platelet-Rich Plasma Injections in the Sacroiliac Joint using ultrasonography in conjunction with physical examination and Point of Maximal Tenderness will produce statistically significant pain relief for more than 3 months as measured by the Numeric Rating Scale for Pain (NRS) and Oswestry Disability Index (ODI)."

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other Names:
  • PRP Joint Injection
  • PRP




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of sacroiliitis
  • Age 18 to 80 years old
  • Chronic low back pain
  • SI joint pathology is the predominant source of pain
  • Positive Fortin Finger Test (PMT)
  • Joint anatomy is identifiable using ultrasonography
  • Patient has no other comorbidities that contraindicate the procedure
  • Patient has attempted physical therapy and corticosteroid injections with local anesthetic -Previous injections of lidocaine and corticosteroid provided at least minor immediate relief
  • Patient must not have had a corticosteroid injection in the SI joint within the last three months
  • Patient must consent to the procedure

Exclusion Criteria:

  • Patients under the age of 18 (Subjects under the age of 18 will not be included in this study due to the continued growth and development of their joints and unstudied effects on children.)
  • Over the age of 80
  • Multiple pain sources and multifactorial pain sources that complicated or confound diagnosing the SI joint as the primary and predominant pain generator that may contribute to low back pain (including but not limited to: lumbar diagnosis, lumbar radiculopathy, intra or extra-articular hip pathology to include acetabulum and femoral head, lumbo-sacral joint pathology, intervertebral disk disease, spondylolisthesis/spondylosis/spondylolysis of lumbar vertebra)
  • Immunosuppressed/immune compromised
  • Underlying comorbidities that contraindicate the procedure (including but not limited to polycythemia, coagulation disorder, or malignancy).

Information from the National Library of Medicine

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


Locations
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United States, Colorado
Star Spine and Sport
Golden, Colorado, United States, 80401
Sponsors and Collaborators
Star Spine and Sport
Investigators
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Principal Investigator: Douglas Hemler, MD Star Spine and Sport, Rocky Vista University College of Osteopathic Medicine

Publications:
Lennard T, Fortin J. Sacroiliac Joint Injection and Arthrographic Imaging Correlation In: Physiatric Procedures in Clinical Practice. Philadelphia: Hanley & Belfus, 1995. 242-253.
Hassan AS, El-Shafey AM, Ahmed HS, Hamed MS. Effectiveness of the intra-articular injection of platelet rich plasma in the treatment of patients with primary knee osteoarthritis. The Egyptian Rheumatologist. 2015;37(3):119-124.

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Responsible Party: Douglas Hemler, Principal Investigator, Star Spine and Sport
ClinicalTrials.gov Identifier: NCT03122119    
Other Study ID Numbers: PRP SIJ Injection Ultrasound
First Posted: April 20, 2017    Key Record Dates
Last Update Posted: September 3, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Douglas Hemler, Star Spine and Sport:
Sacroiliac
Joint Injection
Platelet Rich Plasma
Ultrasound
Low Back Pain
Additional relevant MeSH terms:
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Sacroiliitis
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Arthritis
Joint Diseases
Musculoskeletal Diseases