Platelet-Rich Plasma in Acute Muscle Injuries

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: April 8, 2019

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.

Interventions

  • Biological: PRP
    • Platelet-Rich Plasma
  • Other: Traumeel
    • Homeophatic Treatment

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Return to play (recovery period)
    • Time Frame: average of 3-6 weeks. Until play again a football match (training or competition)
    • Days elapsed since muscular injury apperars until the return to play
  • Pain intensity
    • Time Frame: 3 months since the injury
    • 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).

Secondary Measures

  • Incidence of Recurrences
    • Time Frame: Less than 6 months since the first injury
    • 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).
  • Number of adverse effects
    • Time Frame: Through study completion, an average of 1 year
    • Any reaction with the product injected

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of the Basque Country (UPV/EHU)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Javier González Iglesias, Medical Doctor (orthopedic surgeon) – University of the Basque Country (UPV/EHU)
  • Overall Official(s)
    • Javier Gonzalez Iglesias, Dr, Principal Investigator, Basque Health System – Osakidetza

Citations Reporting on Results

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.

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