Platelet-Rich Plasma in Acute Muscle Injuries
- Conditions
- Muscle Injury
- Interventions
- Other: TraumeelBiological: PRP
- Registration Number
- NCT03676205
- Lead Sponsor
- University of the Basque Country (UPV/EHU)
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- Over 18 years old.
- Acute muscular Injury Type 3a-3b (Múnich classification) in hamstring muscles
- Informed consent signed
- Hamstring injury (last 6 months).
- Previous infiltration in hamstring.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Traumel ® Traumeel 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. Platelet-Rich Plasma PRP 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.
- Primary Outcome Measures
Name Time Method 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).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
- Secondary Outcome Measures
Name Time Method Number of adverse effects Through study completion, an average of 1 year Any reaction with the product injected
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).
Trial Locations
- Locations (1)
Javier Gonzalez Iglesias
🇪🇸Bilbao, Bizkaia, Spain