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

Phase 2

Completed

• Conditions: Acute Hamstring Muscle Strain Injury
• Interventions: Biological: Platelet Poor Plasma (PPP); Biological: Platelet Rich Plasma (PRP)

• Registration Number: NCT01812564
• Lead Sponsor: Aspetar

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2013-02-06
• Study First Submitted QC: 2013-03-13
• Study First Posted: 2013-03-18
• Primary Completion: 2013-10
• Study Completion: 2014-10
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-13
• Last Update Posted: 2015-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PPP	Platelet Poor Plasma (PPP)	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)
PRP	Platelet Rich Plasma (PRP)	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)

Primary Outcome Measures

Name	Time	Method
Time to Return to 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.	Time to return to full sports activity; either training or match play.

Secondary Outcome Measures

Name	Time	Method
Recurrent hamstring lesions.	2 months after return to play, 1 year after return to play.

Trial Locations

Locations (1)

Aspetar; Qatar Orthopaedic and Sports Medicine Hospital; 🇶🇦 Doha, Qatar