Clinical trial NCT01812564: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Hamstring Muscle Strain Injury
Keywords: Platelet rich plasma
Interventional
Randomized
Double-blind
Lead sponsor: Aspetar
Sponsor class: OTHER
First posted: 2013-03-18
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


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

Primary outcomes:
measure: Time to Return to Play
timeFrame: 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 outcomes:
measure: Recurrent hamstring lesions.
timeFrame: 2 months after return to play, 1 year after return to play.
Other outcomes:
measure: Pain during walking, jogging, running, sprinting, acceleration and during training.
timeFrame: 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)
measure: Pain with isometric contraction against resistance assessed with the visual analogue scale(VAS).
timeFrame: 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)
measure: Length and width of pain area during palpation and location of pain on palpation.
timeFrame: 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)
measure: Passive straight leg raising test.
timeFrame: 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)
measure: Full knee extension test at rest.
timeFrame: 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)
measure: 90 degrees hip flexion test.
timeFrame: 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)
measure: (Painful) resisted knee flexion test at 90 degrees.
timeFrame: 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)
measure: Pain with resisted hip extension test at 30 degrees.
timeFrame: 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)
measure: Slump test.
timeFrame: 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)
measure: MRI scoring.
timeFrame: 3 weeks after date of injury.
measure: Hamstring strength
timeFrame: At time of return to play (The expected average return to play time is 27 days)
measure: Adverse effects.
timeFrame: 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.
Locations:
city: Doha
country: Qatar
facility: Aspetar; Qatar Orthopaedic and Sports Medicine Hospital
Study officials:
affiliation: Aspetar
name: Hakim Chalabi, MD
role: STUDY_DIRECTOR
affiliation: Aspetar
name: Bruce Hamilton, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.