Muscle Injury
Conditions
Keywords
Platelet-Rich Plasma, hamstrings, cuadriceps, football players
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.
Interventions
BIOLOGICALPRP
Platelet-Rich Plasma
OTHERTraumeel
Homeophatic Treatment
Sponsors
University of the Basque Country (UPV/EHU)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The patient doesn't know the treatment. The person who analyze the data (outcomes assessor) doesn't know the treatment.
Intervention model description
Two homogeneus groups with 1:1 possibilities to receive PRP or a homeopathic product.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Return to play (recovery period) | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Recurrences | 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 | Through study completion, an average of 1 year | Any reaction with the product injected |
Countries
Spain
Outcome results
None listed