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Completed

NCT Number: NCT01812564

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

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)

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Key information

Conditions

Acute Hamstring Muscle Strain Injury

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Aspetar; Qatar Orthopaedic and Sports Medicine Hospital

Doha, 29222, Qatar

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet Poor Plasma (PPP)

Biological

Platelet Rich Plasma (PRP)

Biological

Primary outcomes

  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 outcomes

  1. Recurrent hamstring lesions.

    Time frame: 2 months after return to play, 1 year after return to play.

Other outcomes

  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.

Sponsors and collaborators

Lead sponsor

Aspetar

Other

Registry information

Official study title

Clinical Utilization of Growth Factors Preparations in the Management of Acute Hamstring Muscle Strain Injury

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Mar 18, 2013
Registry last updated
Jan 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.