Acute Hamstring Muscle Strain Injury Clinical Trial
Official title:
Clinical Utilization of Growth Factors Preparations in the Management of Acute Hamstring Muscle Strain Injury
| Verified date | January 2015 |
| Source | Aspetar |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Qatar: Council of Health |
| Study type | Interventional |
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)
| Status | Completed |
| Enrollment | 90 |
| Est. completion date | October 2014 |
| Est. primary completion date | October 2013 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years to 50 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Qatar | Aspetar; Qatar Orthopaedic and Sports Medicine Hospital | Doha |
| Lead Sponsor | Collaborator |
|---|---|
| Aspetar |
Qatar,
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. — View Citation
Ekstrand J, Healy JC, Waldén M, Lee JC, English B, Hägglund 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. — View 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. — View 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. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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) | No | |
| Other | 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) | No | |
| Other | 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) | No | |
| Other | 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) | No | |
| Other | 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) | No | |
| Other | 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) | No | |
| Other | (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) | No | |
| Other | 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) | No | |
| Other | 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) | No | |
| Other | MRI scoring. | 3 weeks after date of injury. | No | |
| Other | Hamstring strength | At time of return to play (The expected average return to play time is 27 days) | No | |
| Other | 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. | No | |
| Primary | 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. | No |
| Secondary | Recurrent hamstring lesions. | 2 months after return to play, 1 year after return to play. | No |