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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PPP | Placebo Comparator | 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) |
|
| PRP | Active Comparator | 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) |
|
| Physiotherapy | No Intervention | 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet Poor Plasma (PPP) | Biological |
| ||
| Platelet Rich Plasma (PRP) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Return to Play | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent hamstring lesions. | 2 months after return to play, 1 year after return to play. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain during walking, jogging, running, sprinting, acceleration and during training. | 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). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hakim Chalabi, MD | Aspetar | Study Director |
| Bruce Hamilton, MD | Aspetar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aspetar; Qatar Orthopaedic and Sports Medicine Hospital | Doha | 29222 | Qatar |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22144005 | Background | 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. | |
| 20068208 | Background | 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. |
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|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 3 weeks after date of injury. |
| Hamstring strength | At time of return to play (The expected average return to play time is 27 days) |
| Adverse effects. | 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. |
| 21200168 | Background | 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. |
| 20973348 | Background | Hamilton B, Knez W, Eirale C, Chalabi H. Platelet enriched plasma for acute muscle injury. Acta Orthop Belg. 2010 Aug;76(4):443-8. |
| 38729628 | Derived | Zein MI, Mokkenstorm MJK, Cardinale M, Holtzhausen L, Whiteley R, Moen MH, Reurink G, Tol JL; Qatari and Dutch Hamstring Study Group. Baseline clinical and MRI risk factors for hamstring reinjury showing the value of performing baseline MRI and delaying return to play: a multicentre, prospective cohort of 330 acute hamstring injuries. Br J Sports Med. 2024 Jul 1;58(14):766-776. doi: 10.1136/bjsports-2023-107878. |
| 29084725 | Derived | 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. |
| 26843538 | Derived | 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. |
| 26305004 | Derived | 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. |
| 26136179 | Derived | 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. |
| 25037201 | Derived | 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. |