Use of Platelet Rich Plasma in the Management of Acute Hamstring Muscle Strain Injury

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the therapeutic benefit of utilizing complex growth factor preparations (Platelet Rich Plasma (PRP) in the management of acute hamstring injuries. The hypothesis is that the time to return to sport is shorter in the patient group treated with Complex Growth Factor Preparations (PRP) in combination with exercise therapy in comparison with 2 control groups: the patient group treated with Platelet Poor Plasma (PPP) injections in combination with exercise therapy (control injection AND usual care). the patient group treated with exercise therapy (usual care)

Official Title
-----------------
Clinical Utilization of Growth Factors Preparations in the Management of Acute Hamstring Muscle Strain Injury

Conditions
-----------------
Acute Hamstring Muscle Strain Injury

Intervention / Treatment
-----------------
* Biological: Platelet Poor Plasma (PPP)
* Biological: Platelet Rich Plasma (PRP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute onset posterior thigh pain MRI confirmed Grade I, II hamstring lesions < 5 days from injury Able to perform Physiotherapy at ASPETAR (5 sessions/week) Available for follow-up Male Age > 18 years Exclusion Criteria: Diabetes, immuno-compromised state Overlying skin infection Re-injury or Chronic ongoing hamstring injury Unwilling to comply with follow up Contraindication to MRI Needle Phobia Bleeding disorder or other medical contraindication to injection Medication increasing bleeding risk (e.g. Plavix) Concurrent other injury inhibiting rehabilitation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: PPP<br>Placebo: Platelet Poor Plasma Under sterile conditions, patients will receive under ultrasound guidance 3 times, 1 cc injection of PPP each, administered by a sports medicine physician (total 3 cc PPP). Following the completion of the injections (treatment or control) physiotherapy will commence. Physiotherapy protocols will be based on current ASPETAR best practice models (usual care) | Biological: Platelet Poor Plasma (PPP)<br> <br> |
| Active Comparator: PRP<br>Biological: Platelet Rich Plasma Under sterile ultrasound conditions, patients will receive under ultrasound guidance 3 times, 1 cc injection of PRP each, administered by a sports medicine physician (total 3 cc PRP). Following the completion of the injections (treatment or control) physiotherapy will commence. Physiotherapy protocols will be based on current ASPETAR best practice models (usual care) | Biological: Platelet Rich Plasma (PRP)<br> <br> |
| No Intervention: Physiotherapy<br>These patients will not receive an injection. Following the inclusion physiotherapy will commence. Physiotherapy protocols will be based on current ASPETAR best practice models (usual care) | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Return to Play | Time to return to full sports activity; either training or match play. | Patients will be followed for the duration of time to return to play with an expected average of 27 days and up to 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent hamstring lesions. |  | 2 months after return to play, 1 year after return to play. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Platelet rich plasma, Interventional, Randomized, Double-blind