Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet-Rich Plasma | Experimental | 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. |
|
| Traumel ® | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRP | Biological | Platelet-Rich Plasma |
| |
| Traumeel |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Javier Gonzalez Iglesias, Dr | Basque Health System - Osakidetza | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Javier Gonzalez Iglesias | Bilbao | Bizkaia | 48415 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23885648 | Result | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C433370 | Traumeel S |
Not provided
Not provided
Not provided
Two homogeneus groups with 1:1 possibilities to receive PRP or a homeopathic product.
Not provided
Not provided
The patient doesn't know the treatment. The person who analyze the data (outcomes assessor) doesn't know the treatment.
| Other |
Homeophatic Treatment |
|
Any reaction with the product injected |
| Through study completion, an average of 1 year |