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Intradiscal Platelet Rich Plasma

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04544709
Recruitment Status : Recruiting
First Posted : September 10, 2020
Last Update Posted : September 10, 2020
Sponsor:
Information provided by (Responsible Party):
Zack McCormick, University of Utah

Brief Summary:
To assess changes in pain and function in patients with discogenic low back pain after a standard of care intradiscal injection of Platelet-Rich Plasma (PRP).

Condition or disease Intervention/treatment Phase
Discogenic Pain Low Back Pain Chronic Pain Drug: Low back intradiscal injection of platelet rich plasma (PRP) Phase 4

Detailed Description:

Low back pain is one of a few conditions which affects all individuals through the lifespan. The etiology of low back pain is multifactorial and in many cases self-limiting, however it also is the leading cause for working age adults to be disabled with more than $87 billion spent on low back pain disorders in 2013 Lumbar disc herniation and internal disc disruption are two causes more common in these younger age groups reaching 39-42% with a predicted probability above 60% until age 50y. While the natural history of disc herniation suggests most individuals will return to a prior level of function in 3-6 months, there is a high rate of recurrent episodes which can cause short-term disability. Continued pain from a discogenic source can lead to decreased activity levels and accelerate degenerative changes in the disc and facet joints as described by Kirkaldy-Willis.

Current guidelines for treatment of axial low back pain from discogenic sources including those with radiculopathy include a 6-12-week course of conservative care including medications, therapy, acupuncture, chiropractic and exercise before an interventional paradigm of injections and/or surgical treatment. For those individuals who do not improve with conservative care and have predominately axial pain, options are limited as success rates from epidural steroid injections and surgery are 50% or less. Other treatments include chymopapain injection, intradiscal electrothermal annuloplasty (IDET), nucleoplasty, methylene blue injection, ozone injection , fibrin sealant injections. All of which have 50% or less likelihood of reducing pain more than 50%, although much of this data is from uncontrolled or prospective case-control studies only.

Platelet- rich plasma (PRP) injections stand apart from those listed above in that they are purported to be "regenerative" interventions for the diseased lumbar disc. PRP is a concentrated injectant of growth factors and anabolic factors which have in vitro and animal studies that have demonstrated upregulated proteoglycan synthesis and nucleus pulposus proliferation, restoration of disc height, healing of annular puncture wounds and anti-inflammatory effect with down regulation of TNF-alpha and IL-1. There has been limited clinical trials in humans on the effect of intradiscal PRP, including 3 trials of which 1 is a RCT and 2 are prospective series. Efficacy of intra-discal injection has shown statistically significant benefits in reduction in pain, improvement in physical function at follow-up points from 3-24 months. Each of these trials have limited sample sizes, short duration follow-up and lack of a standardized PRP preparation, making the generalizability difficult.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intradiscal Platelet-Rich Plasma Injection for Chronic Discogenic Low Back Pain
Actual Study Start Date : February 14, 2019
Estimated Primary Completion Date : February 14, 2023
Estimated Study Completion Date : July 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Discogenic Low Back Pain
Patient with Refractory Discogenic Low back pain who will be scheduled for platelet rich plasma injection as standard of care.
Drug: Low back intradiscal injection of platelet rich plasma (PRP)
SOC Intradiscal Lumbar PRP Procedure : A small amount of blood is drawn from you, then it is spun in a centrifuge to obtain only the platelets and few other cells. After being spun the small amount of platelets will be injected into the specific disc that is believed to be causing pain in an attempt to help reduce inflammation and pain at the site. The injection will be done under fluoroscopic guidance (x-ray) that allows very careful and precise placement of the needle.




Primary Outcome Measures :
  1. Numeric Rating Scale for Pain at 2 month Follow-up [ Time Frame: 2 months ]
    Proportion of participants with >80% and >50% decrease in back pain on the Numeric Rating Scale pain score at the 2-month follow-up assessment.


Secondary Outcome Measures :
  1. Numeric Rating Scale Median [ Time Frame: 5 years ]
    Change in median Numeric Rating Scale pain score



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Age greater than 18 years of age at day of enrollment.
  2. Clinical diagnosis of refractory discogenic low back pain for >3 months.
  3. Magnetic resonance imaging pathology consistent with clinical symptoms/signs or positive lumbar provocative discography according to SIS/IASP standards at one or two levels.
  4. Back pain greater than leg pain with an intensity of at least 4/10 or higher using the Numerical Rating Scale (NRS).
  5. Pain duration of more than 12 weeks despite trial of conservative therapy (medications, physical therapy, or chiropractic care) for 2 months.

Exclusion Criteria:

  1. Refusal to participate, provide consent, or provide follow-up information for the 24-month duration of the study.
  2. Contraindications to intradiscal injection of PRP (active infection, bleeding disorders, current anticoagulant or antiplatelet medication use, allergy to iodinated contrast, penicillin or clindamycin and pregnancy or breastfeeding).
  3. More than 2 levels of clinical or discogram proven pain.
  4. Non-discogenic source of low back pain as identified by separate diagnostic blocks.
  5. Negative lumbar provocation discography.
  6. Active moderate to severe lumbar radiculopathy.
  7. Intradural disc herniation.
  8. Spinal fracture within the past 6 months.
  9. Steroid injection in the spine within the last 30 days.
  10. Any intradiscal injection other than contrast dye or anesthetic in the last 30 days.
  11. Prior fusion at level considered to be the source of the pain.
  12. Prior lumbar spine surgery within the last 6 months.
  13. AP diameter of spinal canal less than or equal to 9mm at level to be treated.
  14. Severe uncontrolled medical condition.
  15. Moderate to severe hepatic dysfunction.
  16. Severe psychological illness.
  17. History of Inflammatory arthritis.
  18. Malignancy within past 5 years except basal cell or squamous cell skin cancer.
  19. Current use of equal to greater than 30mg morphine-equivalent per day of opioid use.
  20. A history of alcohol or drug abuse within past 5 years.
  21. Use of any investigational drug within past 30 days.
  22. A known allergy or sensitivity to citrate (used for processing PRP).
  23. Severe anaphylactic/anaphylactoid reaction to any medications used.
  24. Pending litigation involving subject's back pain.
  25. No insurance coverage for any subsequent tests or procedures.
  26. Disc protrusion greater than 5mm from base of vertebral body.
  27. Greater than 50% disc height loss at involved level(s).
  28. Inability or unwillingness to continue rehabilitation protocols.

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): NCT04544709


Contacts
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Contact: Shellie Cunningham, BS 801-587-5488 shellie.cunningham@hsc.utah.edu
Contact: Talmage Morris 801-213-1283 talmage.morris@hsc.utah.edu

Locations
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United States, Utah
University of Utah Orthopaedic Center Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Shellie S Cunningham, BS    801-587-5488    shellie.cunningham@hsc.utah.edu   
Sponsors and Collaborators
University of Utah
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Responsible Party: Zack McCormick, Zachary McCormick, MD FAAPMR, Associate Professor, Director of Clinical Spine Research, Director of Interventional Spine and Musculoskeletal Medicine Fellowship, University of Utah
ClinicalTrials.gov Identifier: NCT04544709    
Other Study ID Numbers: IRB 117455
First Posted: September 10, 2020    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020
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 Zack McCormick, University of Utah:
Platelet Rich Plasma
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Chronic Pain
Pain
Neurologic Manifestations