Platelet-Rich Plasma in Acute Muscle Injuries

Randomized Clinical Trial About the Therapeutic Use of Platelet-Rich Plasma (PRP) for the Treatment of Acute Muscular Injuries in Football Players.

OBJECTIVE: To evaluate the effect of Platelet Rich Plasma (PRP) injection in muscle injuries. The investigators check football players in the acute phase of hamstrings or quadriceps injuries.

Efficacy and safety are evaluated. There are two intramuscular infiltration of PRP (Ortho pras ® system) or a homeopathic product (Traumeel ®) in each of the football players. The number of days between the date of injury and the return to play, the pain, the recurrence and the adverse reactions are registered.

Study Overview

• Status: Completed
• Conditions: Muscle Injury
• Intervention / Treatment: Biological: PRP; Other: Traumeel

Detailed Description

STUDY DESIGN: Randomized Clinical Trial.

METHODS:

41 football players are included in the study. It is used randomly PRP injection or a homeopathic product in muscle injuries (hamstring), in the early stage (first 48-72 hours).

One week later, the investigators do a second infiltration with the same product, always ultrasound guided. 3-4 weeks after the injury, different variables are evaluated: the injurie with ultrasounds , self-perception test, muscle strength, flexibility, jump and run. It is compared the elapsed time in days in each of the groups: RETURN TO PLAY.

Furthermore, the PAIN, RECURRENCE RATE and ADVERSE REACTIONS are evaluated.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Bizkaia
    • Bilbao, Bizkaia, Spain, 48415
      • Javier Gonzalez Iglesias

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Over 18 years old.
• Acute muscular Injury Type 3a-3b (Múnich classification) in hamstring muscles
• Informed consent signed

Exclusion Criteria:

• Hamstring injury (last 6 months).
• Previous infiltration in hamstring.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Platelet-Rich Plasma; 24-72 hours after having a muscular lesion, the doctor injects an intramuscular ecoguided infiltration of 6-7 ml of PRP . After 4-5 days from the injury the patient starts physiotherapy adapted by stages, according to the muscular group affected. After 7 days from the first infiltration, the patient will recived the second infiltration of 6-7 ml of PRP.	Biological: PRP; Platelet-Rich Plasma
Other: Traumel ®; 24-72 hours after having a muscular lesion, the doctor injects an intramuscular ecoguided infiltration of 4 ml of a homeopathic product (Traumeel ®) After 4-5 days from the date of injury, the patient starts physiotherapy adapted by stages, according to the muscular group affected. After 7 days from the first infiltration, the patient will receive the second infiltration of 4 ml of a homeopathic product.	Other: Traumeel; Homeophatic Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return to play (recovery period)	Days elapsed since muscular injury apperars until the return to play	average of 3-6 weeks. Until play again a football match (training or competition)
Pain intensity	Pain after the muscle injury, and after the injections, with: -Funtional outcomes: pain (0 no pain; 10 unbearable pain) at rest, walking and going up and down the stairs. The Brief Pain Inventory - Short Form. Pain intensity (0, no pain - 10 unbearable) and interferences with the daily activities (0, does not interfere; 10, completely interferes).	3 months since the injury

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Recurrences	Recurrence: other injury in the same muscle group during the 6 months after the first injury Complication: other injurie or disease in other location of the body (no in the same muscular group).	Less than 6 months since the first injury
Number of adverse effects	Any reaction with the product injected	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: University of the Basque Country (UPV/EHU)
• Investigators: Principal Investigator: Javier Gonzalez Iglesias, Dr, Basque Health System - Osakidetza

Publications and helpful links

General Publications

• Gonzalez-Iglesias J. [Therapeutic potential of platelet rich plasma. Reflections on its research and development]. Rev Esp Cir Ortop Traumatol. 2013 Jul-Aug;57(4):237-9. doi: 10.1016/j.recot.2013.04.001. Epub 2013 May 28. No abstract available. Spanish.

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2016
• Primary Completion (Actual): April 8, 2019
• Study Completion (Actual): January 8, 2020

Study Registration Dates

• First Submitted: September 13, 2018
• First Submitted That Met QC Criteria: September 16, 2018
• First Posted (Actual): September 18, 2018

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 19, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: hamstrings; Platelet-Rich Plasma; cuadriceps; football players
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: PRP-MUSCULO-2014-2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No