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

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01200875
• Collaborator: Partnership for Clean Competition (Other)
• Enrollment: 25
• Location: 1
• Duration (Months): 34
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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	Phase
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

• 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: Jul 1, 2010
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: May 1, 2013

Outcome Measures

Primary Outcome Measures

1. Blood Growth Factor Concentrations [5 days following PRP injection]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	New York University Langone Orthopedic Hospital	New York	New York	United States	10010

Sponsors and Collaborators

• Stanford University
• Partnership for Clean Competition

Investigators

• Study Director: Dr. Christina Herrero, New York University Langone Orthopedic Hospital
• Principal Investigator: Dr. Jason L. Dragoo, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jason L. Dragoo, Associate Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT01200875
• Other Study ID Numbers: SU-08032010-6646; 18963
• First Posted: Sep 14, 2010
• Last Update Posted: Aug 6, 2018
• Last Verified: Aug 1, 2018

• Keywords provided by Jason L. Dragoo, Associate Professor, Stanford University: PRP; platelet rich plasma; platelet; growth hormone; tendonitis; tendinosis; tendinopathy; enthesopathy; muscle; sport; tendon
• Additional relevant MeSH terms: Rheumatic Diseases; Tendinopathy; Collagen Diseases

Study Results

Participant Flow

Arm/Group Title	PRP Injection (All Patients)
Arm/Group Description	All patients receiving local ultrasound-guided intratendinous PRP injection at our institution between July 2010 and December 2011 were screened for eligibility to participate in the study, and 25 patients were ultimately enrolled.
Period Title: Overall Study
STARTED	25
COMPLETED	25
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Treatment Arm
Arm/Group Description	All patients receiving local ultrasound-guided intratendinous PRP injection at our institution between July 2010 and December 2011 were screened for eligibility to participate in the study, and 25 patients were ultimately enrolled.
Overall Participants	25
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.5 (11.3)
Sex: Female, Male (Count of Participants)
Female	19 76%
Male	6 24%
Region of Enrollment (participants) [Number]
United States	25 100%

Outcome Measures

1. Primary Outcome

Title	Blood Growth Factor Concentrations
Time Frame	5 days following PRP injection

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PRP Injection (All Patients)
Arm/Group Description	All patients receiving local ultrasound-guided intratendinous PRP injection at our institution between July 2010 and December 2011 were screened for eligibility to participate in the study, and 25 patients were ultimately enrolled.
Measure Participants	25
Mean (95% Confidence Interval) [IGF-1 fold-change from baseline @ 24h]	1.078

Adverse Events

Arm/Group Title	Treatment Arm
Arm/Group Description	All patients receiving local ultrasound-guided intratendinous PRP injection at our institution between July 2010 and December 2011 were screened for eligibility to participate in the study, and 25 patients were ultimately enrolled.
All Cause Mortality
	Treatment Arm
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Treatment Arm
	Affected / at Risk (%)	# Events
Total	0/25 (0%)
Other (Not Including Serious) Adverse Events
	Treatment Arm
	Affected / at Risk (%)	# Events
Total	0/25 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.