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

Primary Purpose

Acute Hamstring Muscle Strain Injury

Status
Completed
Phase
Phase 2
Locations
Qatar
Study Type
Interventional
Intervention
Platelet Poor Plasma (PPP)
Platelet Rich Plasma (PRP)
Sponsored by
Aspetar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Hamstring Muscle Strain Injury focused on measuring Platelet rich plasma, Interventional, Randomized, Double-blind

Eligibility Criteria

18 Years - 50 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Aspetar; Qatar Orthopaedic and Sports Medicine Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

No Intervention

Arm Label

PPP

PRP

Physiotherapy

Arm Description

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 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)

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)

Outcomes

Primary Outcome Measures

Time to Return to Play
Time to return to full sports activity; either training or match play.

Secondary Outcome Measures

Recurrent hamstring lesions.

Full Information

First Posted
February 6, 2013
Last Updated
January 13, 2015
Sponsor
Aspetar
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1. Study Identification

Unique Protocol Identification Number
NCT01812564
Brief Title
Use of Platelet Rich Plasma in the Management of Acute Hamstring Muscle Strain Injury
Official Title
Clinical Utilization of Growth Factors Preparations in the Management of Acute Hamstring Muscle Strain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aspetar

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Hamstring Muscle Strain Injury
Keywords
Platelet rich plasma, Interventional, Randomized, Double-blind

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PPP
Arm Type
Placebo Comparator
Arm Description
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)
Arm Title
PRP
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Physiotherapy
Arm Type
No Intervention
Arm Description
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)
Intervention Type
Biological
Intervention Name(s)
Platelet Poor Plasma (PPP)
Intervention Type
Biological
Intervention Name(s)
Platelet Rich Plasma (PRP)
Primary Outcome Measure Information:
Title
Time to Return to Play
Description
Time to return to full sports activity; either training or match 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.
Secondary Outcome Measure Information:
Title
Recurrent hamstring lesions.
Time Frame
2 months after return to play, 1 year after return to play.
Other Pre-specified Outcome Measures:
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
(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)
Title
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)
Title
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)
Title
MRI scoring.
Time Frame
3 weeks after date of injury.
Title
Hamstring strength
Time Frame
At time of return to play (The expected average return to play time is 27 days)
Title
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.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hakim Chalabi, MD
Organizational Affiliation
Aspetar
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bruce Hamilton, MD
Organizational Affiliation
Aspetar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aspetar; Qatar Orthopaedic and Sports Medicine Hospital
City
Doha
ZIP/Postal Code
29222
Country
Qatar

12. IPD Sharing Statement

Citations:
PubMed Identifier
22144005
Citation
Ekstrand J, Healy JC, Walden M, Lee JC, English B, Hagglund M. Hamstring muscle injuries in professional football: the correlation of MRI findings with return to play. Br J Sports Med. 2012 Feb;46(2):112-7. doi: 10.1136/bjsports-2011-090155. Epub 2011 Dec 5.
Results Reference
background
PubMed Identifier
20068208
Citation
de Vos RJ, Weir A, van Schie HT, Bierma-Zeinstra SM, Verhaar JA, Weinans H, Tol JL. Platelet-rich plasma injection for chronic Achilles tendinopathy: a randomized controlled trial. JAMA. 2010 Jan 13;303(2):144-9. doi: 10.1001/jama.2009.1986.
Results Reference
background
PubMed Identifier
21200168
Citation
Hamilton BH, Best TM. Platelet-enriched plasma and muscle strain injuries: challenges imposed by the burden of proof. Clin J Sport Med. 2011 Jan;21(1):31-6. doi: 10.1097/JSM.0b013e318205a658.
Results Reference
background
PubMed Identifier
20973348
Citation
Hamilton B, Knez W, Eirale C, Chalabi H. Platelet enriched plasma for acute muscle injury. Acta Orthop Belg. 2010 Aug;76(4):443-8.
Results Reference
background
PubMed Identifier
29084725
Citation
Whiteley R, van Dyk N, Wangensteen A, Hansen C. Clinical implications from daily physiotherapy examination of 131 acute hamstring injuries and their association with running speed and rehabilitation progression. Br J Sports Med. 2018 Mar;52(5):303-310. doi: 10.1136/bjsports-2017-097616. Epub 2017 Oct 30.
Results Reference
derived
PubMed Identifier
26843538
Citation
Jacobsen P, Witvrouw E, Muxart P, Tol JL, Whiteley R. A combination of initial and follow-up physiotherapist examination predicts physician-determined time to return to play after hamstring injury, with no added value of MRI. Br J Sports Med. 2016 Apr;50(7):431-9. doi: 10.1136/bjsports-2015-095073. Epub 2016 Feb 3.
Results Reference
derived
PubMed Identifier
26305004
Citation
Wangensteen A, Almusa E, Boukarroum S, Farooq A, Hamilton B, Whiteley R, Bahr R, Tol JL. MRI does not add value over and above patient history and clinical examination in predicting time to return to sport after acute hamstring injuries: a prospective cohort of 180 male athletes. Br J Sports Med. 2015 Dec;49(24):1579-87. doi: 10.1136/bjsports-2015-094892. Epub 2015 Aug 24.
Results Reference
derived
PubMed Identifier
26136179
Citation
Hamilton B, Tol JL, Almusa E, Boukarroum S, Eirale C, Farooq A, Whiteley R, Chalabi H. Platelet-rich plasma does not enhance return to play in hamstring injuries: a randomised controlled trial. Br J Sports Med. 2015 Jul;49(14):943-50. doi: 10.1136/bjsports-2015-094603.
Results Reference
derived
PubMed Identifier
25037201
Citation
De Vos RJ, Reurink G, Goudswaard GJ, Moen MH, Weir A, Tol JL. Clinical findings just after return to play predict hamstring re-injury, but baseline MRI findings do not. Br J Sports Med. 2014 Sep;48(18):1377-84. doi: 10.1136/bjsports-2014-093737. Epub 2014 Jul 18.
Results Reference
derived

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

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