Platelet-Rich Plasma in Acute Muscle Injuries

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Muscle Injury

Intervention / Treatment
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* Biological: PRP
* Other: Traumeel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two homogeneus groups with 1:1 possibilities to receive PRP or a homeopathic product.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet-Rich Plasma<br>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<br>* Platelet-Rich Plasma<br>|
| Other: Traumel ®<br>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<br>* Homeophatic Treatment<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cuadriceps, football players, hamstrings, Platelet-Rich Plasma