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Performance-Enhancing Effects of Platelet-Rich Plasma (PRP) Injections

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ClinicalTrials.gov Identifier: NCT01200875
Recruitment Status : Completed
First Posted : September 14, 2010
Results First Posted : December 6, 2016
Last Update Posted : August 6, 2018
Sponsor:
Collaborator:
Partnership for Clean Competition
Information provided by (Responsible Party):
Jason L. Dragoo, Stanford University

Study Description
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Brief Summary:

Platelet-Rich Plasma (PRP) has been banned in competitive athletes because some people think it may enhance athletic performance. However, there is very little published research to support or undermine this point of view. The purposes of this study are: (1) To assess the effects of local platelet-rich plasma (PRP) therapy on systemic levels of growth factors with suspected or known performance-enhancing effects; and (2) To understand whether the effect of PRP therapy on these growth factors differs between intramuscular and intratendinous PRP injections.

This research study is looking for 40 people who are receiving platelet-rich plasma therapy for a tendon or muscle injury. The study involves collecting seven blood samples (2 teaspoons each) from each patient, before and after the PRP treatment. Blood samples may be donated at any location of the patient's choosing, and participants will be paid for their time.


Condition or disease Intervention/treatment
Tendinopathy Rheumatic Diseases Procedure: Ultrasound-guided platelet-rich-plasma (PRP) injection Procedure: Platelet-Rich Plasma (PRP)

Detailed Description:

To understand the short-term systemic effects of local PRP injections, we will measure the serum concentrations of six growth factors before and during the four days following PRP injection: human growth hormone (hGH), IGF-1, basic FGF, PDGF-BB, VEGF, and IGFBP-3. These molecules are of particular interest because they may have stimulatory effects that enhance athletic performance, and because they have been banned in competitive athletes by the World Anti-Doping Agency (WADA).

We aim to recruit 40 patients who are receiving ultrasound-guided intratendinous (IT) or intramuscular (IM) PRP injections. Blood will be drawn immediately before (baseline); 15 minutes after; and 3, 24, 48, 72 and 96 hours after receiving PRP therapy. A fraction of the therapeutic PRP preparation will be isolated for growth factor analysis. Serum concentrations of growth factors will be quantified by ELISA. Statistical analyses will be conducted to assess the change in each growth factor following PRP injection. To understand the impact of injection site on systemic growth factors, changes in concentration will also be compared between the intratendinous and intramuscular groups.

Study subjects will participate in the following steps: (1) Initial diagnostic visit with Orthopaedic Surgeon, (2) Blood collection as part of PRP therapy, (3) Ultrasound-guided PRP therapy administered by Stanford radiologist, and (4) Blood collection for the study. Steps (1) through (3) are all part of the standard of care, which the patient will have chosen independently of the study. In step (4), blood samples will be collected by venipuncture at various time points and assayed for growth factor concentrations. Less than 10 mL (2 teaspoons) of blood will be collected at each of seven time points over five consecutive days. In order to minimize inconvenience to the patient we will meet patients at a location of their choosing, such as the patient's home or office, for blood collection on days 2-5. Participants will be compensated after all seven blood samples have been donated.

Study Design
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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effect of Intramuscular and Intratendinous Platelet-Rich Plasma Injections on Systemic Concentrations of Performance-Enhancing Growth Factors
Study Start Date : July 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : May 2013
Groups and Cohorts
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Intervention Details:
  • Procedure: Ultrasound-guided platelet-rich-plasma (PRP) injection
    One ultrasound-guided intratendinous or intramuscular PRP injection
  • Procedure: Platelet-Rich Plasma (PRP)
    One ultrasound-guided PRP injection
    Other Names:
    • PRP
    • Platelet Rich Plasma
    • Platelet-Rich-Plasma

Outcome Measures
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Primary Outcome Measures :
  1. Blood Growth Factor Concentrations [ Time Frame: 5 days following PRP injection ]

Biospecimen Retention:   Samples Without DNA
Blood serum, blood plasma, and platelet-rich-plasma (PRP)

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients receiving intramuscular or intratendinous platelet-rich-plasma (PRP) for treatment of muscle or tendon injury.
Criteria

Inclusion Criteria:

  • Male and female patients 18-50 years old, receiving ultrasound-guided intratendinous or intramuscular PRP injections

Exclusion Criteria:

  • History of cancer, diabetes, hormone-replacement therapy, or abnormal nutritional habits.

  • Contraindications for PRP therapy itself:

    • preexisting coagulation defects including thrombocytopenia
    • hypofibrinogenemia
    • anticoagulation medications
    • hypersensitivity to bovine products, which may be used for platelet activation.
Contacts and Locations
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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): NCT01200875


Locations
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United States, New York
New York University Langone Orthopedic Hospital
New York, New York, United States, 10010
Sponsors and Collaborators
Stanford University
Partnership for Clean Competition
Investigators
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Study Director: Dr. Christina Herrero New York University Langone Orthopedic Hospital
Principal Investigator: Dr. Jason L. Dragoo Stanford University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jason L. Dragoo, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01200875    
Other Study ID Numbers: SU-08032010-6646
18963 ( Other Identifier: Stanford IRB )
First Posted: September 14, 2010    Key Record Dates
Results First Posted: December 6, 2016
Last Update Posted: August 6, 2018
Last Verified: August 2018
Keywords provided by Jason L. Dragoo, Stanford University:
PRP
platelet rich plasma
platelet
growth hormone
tendonitis
tendinosis
 tendinopathy
enthesopathy
muscle
sport
tendon
Additional relevant MeSH terms:
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Rheumatic Diseases
Tendinopathy
Collagen Diseases
Musculoskeletal Diseases
 Connective Tissue Diseases
Muscular Diseases
Tendon Injuries
Wounds and Injuries