Use of Platelet Rich Plasma in the Management of Acute Hamstring Muscle Strain Injury
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ClinicalTrials.gov Identifier: NCT01812564 |
Recruitment Status :
Completed
First Posted : March 18, 2013
Last Update Posted : January 14, 2015
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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)
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Hamstring Muscle Strain Injury | Biological: Platelet Poor Plasma (PPP) Biological: Platelet Rich Plasma (PRP) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 90 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Clinical Utilization of Growth Factors Preparations in the Management of Acute Hamstring Muscle Strain Injury |
Study Start Date : | November 2009 |
Actual Primary Completion Date : | October 2013 |
Actual Study Completion Date : | October 2014 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: 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) |
Biological: Platelet Poor Plasma (PPP) |
Active Comparator: 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) |
Biological: Platelet Rich Plasma (PRP) |
No Intervention: Physiotherapy
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) |
- Time to Return to Play [ Time Frame: 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.
- Recurrent hamstring lesions. [ Time Frame: 2 months after return to play, 1 year after return to play. ]
- Pain during walking, jogging, running, sprinting, acceleration and during training. [ Time Frame: Once every 7 days from the inclusion date until the time to return to play. (The expected average return to play time is 27 days) ]
- Pain with isometric contraction against resistance assessed with the visual analogue scale(VAS). [ Time Frame: Once every 7 days from the inclusion date until the time to return to play. (The expected average return to play time is 27 days) ]
- Length and width of pain area during palpation and location of pain on palpation. [ Time Frame: Once every 7 days from the inclusion date until the time to return to play. (The expected average return to play time is 27 days) ]
- Passive straight leg raising test. [ Time Frame: Once every 7 days from the inclusion date until the time to return to play. (The expected average return to play time is 27 days) ]
- Full knee extension test at rest. [ Time Frame: Once every 7 days from the inclusion date until the time to return to play. (The expected average return to play time is 27 days) ]
- 90 degrees hip flexion test. [ Time Frame: Once every 7 days from the inclusion date until the time to return to play. (The expected average return to play time is 27 days) ]
- (Painful) resisted knee flexion test at 90 degrees. [ Time Frame: Once every 7 days from the inclusion date until the time to return to play. (The expected average return to play time is 27 days) ]
- Pain with resisted hip extension test at 30 degrees. [ Time Frame: Once every 7 days from the inclusion date until the time to return to play. (The expected average return to play time is 27 days) ]
- Slump test. [ Time Frame: Once every 7 days from the inclusion date until the time to return to play. (The expected average return to play time is 27 days) ]
- MRI scoring. [ Time Frame: 3 weeks after date of injury. ]
- Hamstring strength [ Time Frame: At time of return to play (The expected average return to play time is 27 days) ]
- Adverse effects. [ Time Frame: Once every 7 days from the inclusion date until the time to return to play (the expected average return to play time is 27 days), 2 months after return to play, at the end of the sport season, and at 1 year after return to play. ]

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01812564
Qatar | |
Aspetar; Qatar Orthopaedic and Sports Medicine Hospital | |
Doha, Qatar, 29222 |
Study Director: | Hakim Chalabi, MD | Aspetar | |
Principal Investigator: | Bruce Hamilton, MD | Aspetar |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Aspetar |
ClinicalTrials.gov Identifier: | NCT01812564 |
Other Study ID Numbers: |
GF012 |
First Posted: | March 18, 2013 Key Record Dates |
Last Update Posted: | January 14, 2015 |
Last Verified: | January 2015 |
Platelet rich plasma Interventional Randomized Double-blind |
Wounds and Injuries Sprains and Strains |