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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Aspetar
ClinicalTrials.gov Identifier:
NCT01812564
First received: February 6, 2013
Last updated: September 26, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Acute Hamstring Muscle Strain Injury
Biological: Platelet Poor Plasma (PPP)
Biological: Platelet Rich Plasma (PRP)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Utilization of Growth Factors Preparations in the Management of Acute Hamstring Muscle Strain Injury

Further study details as provided by Aspetar:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Time to return to full sports activity; either training or match play.


Secondary Outcome Measures:
  • Recurrent hamstring lesions. [ Time Frame: 2 months after return to play, 1 year after return to play. ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • (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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • MRI scoring. [ Time Frame: 3 weeks after date of injury. ] [ Designated as safety issue: No ]
  • Hamstring strength [ Time Frame: At time of return to play (The expected average return to play time is 27 days) ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: November 2009
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)


  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01812564

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