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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
Sponsor:
Information provided by (Responsible Party):
Aspetar

Study Description
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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)

Condition or disease Intervention/treatment Phase
Acute Hamstring Muscle Strain Injury Biological: Platelet Poor Plasma (PPP) Biological: Platelet Rich Plasma (PRP) Phase 2

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Recurrent hamstring lesions. [ Time Frame: 2 months after return to play, 1 year after return to play. ]

Other Outcome Measures:
  1. 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) ]
  2. 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) ]
  3. 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) ]
  4. 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) ]
  5. 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) ]
  6. 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) ]
  7. (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) ]
  8. 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) ]
  9. 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) ]
  10. MRI scoring. [ Time Frame: 3 weeks after date of injury. ]
  11. Hamstring strength [ Time Frame: At time of return to play (The expected average return to play time is 27 days) ]
  12. 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. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Qatar
Aspetar; Qatar Orthopaedic and Sports Medicine Hospital
Doha, Qatar, 29222
Sponsors and Collaborators
Aspetar
Investigators
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Study Director: Hakim Chalabi, MD Aspetar
Principal Investigator: Bruce Hamilton, MD Aspetar
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by Aspetar:
Platelet rich plasma
Interventional
Randomized
Double-blind
Additional relevant MeSH terms:
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Wounds and Injuries
Sprains and Strains