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

NCT01812564 | Completed Phase 2

• 1 other identifier: GF012
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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)

Conditions

Acute Hamstring Muscle Strain Injury

Keywords

Platelet rich plasma; Interventional; Randomized; Double-blind

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Recurrent hamstring lesions.

  2 months after return to play, 1 year after return to play.

Other Outcomes (12)

• 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).

  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)

Study Arms (3)

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)

Biological: Platelet Poor Plasma (PPP)

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)

Biological: Platelet Rich Plasma (PRP)

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)

Interventions

Platelet Poor Plasma (PPP) BIOLOGICAL

PPP

Platelet Rich Plasma (PRP) BIOLOGICAL

PRP

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aspetar: lead

Study Sites (1)

Aspetar; Qatar Orthopaedic and Sports Medicine Hospital

Doha, 29222, Qatar

Location

Related Publications (10)

• 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.

  PMID: 22144005 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.

  PMID: 20068208 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.

  PMID: 21200168 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.

  PMID: 20973348 BACKGROUND

• 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.

  PMID: 38729628 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.

  PMID: 29084725 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.

  PMID: 26843538 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.

  PMID: 26305004 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.

  PMID: 26136179 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.

  PMID: 25037201 DERIVED

Study Officials

• Hakim Chalabi, MD

  Aspetar

  STUDY DIRECTOR

• Bruce Hamilton, MD

  Aspetar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2013
• First Posted: March 18, 2013
• Study Start: November 1, 2009
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2014
• Last Updated: January 14, 2015

Record last verified: 2015-01

Locations

QA (1)