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

Aspetar

Status and phase: Completed; Phase 2

Conditions: Acute Hamstring Muscle Strain Injury

Treatments: Biological: Platelet Rich Plasma (PRP); Biological: Platelet Poor Plasma (PPP)

Study type: Interventional

Funder types: Other

Identifiers

NCT01812564

GF012

Details and patient eligibility

About

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)

Enrollment: 90 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups, including a placebo group

PPP

Placebo Comparator group

Description:

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)

Treatment:

Biological: Platelet Poor Plasma (PPP)

PRP

Active Comparator group

Description:

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)

Treatment:

Biological: Platelet Rich Plasma (PRP)

Physiotherapy

No Intervention group

Description:

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)