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

NCT03122119 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: PRP SIJ Injection Ultrasound
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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, and 6 months 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)."

Conditions

Chronic Low Back Pain; Sacroiliitis; Sacroiliac; Backache; Platelet Rich Plasma; Platelet; Injection Site; Ultrasound Therapy; Complications; Treatment

Keywords

Sacroiliac; Joint Injection; Platelet Rich Plasma; Ultrasound; Low Back Pain

Outcome Measures

Primary Outcomes (2)

• Numeric Rating Scale for Pain (NRS)

  Defined as a numeric scale for pain from 0 to 10. 0 demonstrates no pain and 10 demonstrates severe pain or significant impact on activities of daily living.

  Change from baseline compared to 6 months post injection

• Oswestry Disability Index (ODI)

  Standardized questionnaire which asks 10 questions to assess impact on activities of daily living. Minimum score is 0, maximum score is 50. Higher scores mean worse outcome or more impact on function.

  Change from baseline compared to 6 months post injection

Study Arms (1)

Platelet Rich Plasma Joint Injection

EXPERIMENTAL

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

Interventions

Platelet Rich Plasma Joint Injection DRUG

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.

Also known as: PRP Joint Injection, PRP

Platelet Rich Plasma Joint Injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Star Spine and Sport: lead

Study Sites (1)

Star Spine and Sport

Golden, Colorado, 80401, United States

Location

Related Publications (22)

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  BACKGROUND

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MeSH Terms

Conditions

Sacroiliitis; Back Pain; Low Back Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Douglas Hemler, Prinical Investigator
• Organization: Star Spine and Sports

dhemler@starcolorado.com

3035701834

Study Officials

• Douglas Hemler, MD

  Star Spine and Sport, Rocky Vista University College of Osteopathic Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 16, 2017
• First Posted: April 20, 2017
• Study Start: May 1, 2017
• Primary Completion: March 1, 2020
• Study Completion: September 1, 2022
• Last Updated: April 28, 2023
• Results First Posted: April 28, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)