Randomized Clinical Trial About the Therapeutic Use of Platelet-Rich Plasma (PRP) for the Treatment of Acute Muscular Injuries in Football Players.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Muscle Injury
- Sponsor
- University of the Basque Country (UPV/EHU)
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Pain intensity
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
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.
Investigators
Javier González Iglesias
Medical Doctor (orthopedic surgeon)
University of the Basque Country (UPV/EHU)
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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).
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
Secondary Outcomes
- Number of adverse effects(Through study completion, an average of 1 year)
- Incidence of Recurrences(Less than 6 months since the first injury)