Intradiscal Platelet Rich Plasma
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|ClinicalTrials.gov Identifier: NCT04544709|
Recruitment Status : Recruiting
First Posted : September 10, 2020
Last Update Posted : September 10, 2020
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- Numeric Rating Scale Median [ Time Frame: 5 years ]Change in median Numeric Rating Scale pain score
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
|Contact: Shellie Cunningham, BSfirstname.lastname@example.org|
|Contact: Talmage Morrisemail@example.com|
|United States, Utah|
|University of Utah Orthopaedic Center||Recruiting|
|Salt Lake City, Utah, United States, 84108|
|Contact: Shellie S Cunningham, BS 801-587-5488 firstname.lastname@example.org|