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

January 13, 2015 updated by: Aspetar

Clinical Utilization of Growth Factors Preparations 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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Qatar
      • Doha, Qatar, 29222
        • Aspetar; Qatar Orthopaedic and Sports Medicine Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Secondary Outcome Measures

Outcome Measure
Time Frame
Recurrent hamstring lesions.
Time Frame: 2 months after return to play, 1 year after return to play.
2 months after return to play, 1 year after return to play.

Other Outcome Measures

Outcome Measure
Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)
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.
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)
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aspetar

Investigators

  • Study Director: Hakim Chalabi, MD, Aspetar
  • Principal Investigator: Bruce Hamilton, MD, Aspetar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

February 6, 2013

First Submitted That Met QC Criteria

March 13, 2013

First Posted (Estimate)

March 18, 2013

Study Record Updates

Last Update Posted (Estimate)

January 14, 2015

Last Update Submitted That Met QC Criteria

January 13, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GF012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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