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

This study is currently recruiting participants.
Verified June 2011 by Stanford University
Sponsor:
Collaborator:
Partnership for Clean Competition
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01200875
First received: September 2, 2010
Last updated: June 10, 2011
Last verified: June 2011
History of Changes
  Purpose

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 Intervention
Tendinopathy
Rheumatic Diseases
 Procedure: Ultrasound-guided platelet-rich-plasma (PRP) injection
Procedure: Platelet-Rich Plasma (PRP)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Tendinitis
U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Blood growth factor concentrations [ Time Frame: 5 days following PRP injection ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood serum, blood plasma, and platelet-rich-plasma (PRP)


Estimated Enrollment: 40
Study Start Date: July 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01200875

Contacts
Contact: Amy S Wasterlain (718) 644-5731 awasterl@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Amy S Wasterlain     718-644-5731     awasterl@stanford.edu    
Principal Investigator: Dr. Jason L. Dragoo            
Sub-Investigator: Amy Sarah Wasterlain            
Sponsors and Collaborators
Stanford University
Partnership for Clean Competition
Investigators
Sub-Investigator: Amy Sarah Wasterlain Stanford University
Principal Investigator: Dr. Jason L. Dragoo Stanford University
  More Information

No publications provided by Stanford University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Jason L. Dragoo, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT01200875     History of Changes
Other Study ID Numbers: SU-08032010-6646, 18963
Study First Received: September 2, 2010
Last Updated: June 10, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
tendinopathy
PRP
platelet rich plasma
platelet
growth hormone
tendonitis
 tendinosis
enthesopathy
muscle
sport
tendon

Additional relevant MeSH terms:
Rheumatic Diseases
Tendinopathy
Musculoskeletal Diseases
Connective Tissue Diseases
Muscular Diseases
 Tendon Injuries
Wounds and Injuries
Performance-Enhancing Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013