NCT01812564.
| Trial name or title | Use of platelet rich plasma in the management of acute hamstring muscle strain injury |
| Methods | Study design: randomised trial Random sequence generation: not reported Allocation concealment: not reported Masking: double blind (subject, investigator, outcome assessor) |
| Participants | Location: Target sample size (N): 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; immunocompromised 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 |
| Interventions |
PRP: complex growth factor preparations (PRP) in combination with exercise therapy Controls or placebo or no intervention (standard care): 2 groups: 1) PPP injections in combination with exercise therapy (control injection and usual care) and 2) exercise therapy (usual care) |
| Outcomes | Primary outcomes: time to return to play Secondary outcomes: recurrent hamstring lesions; pain during walking, jogging, running, sprinting, acceleration and during training; pain with isometric contraction against resistance assessed with the VAS; length and width of pain area during palpation and location of pain on palpation; passive straight leg raising test; full knee extension test at rest; 90 degrees hip flexion test; (painful) resisted knee flexion test at 90 degrees; pain with resisted hip extension test at 30 degrees; slump test; MRI scoring; hamstring strength; adverse effects Timing of outcomes measurement: every 7 days, 3 weeks after injury (MRI), 2 months, 1 year |
| Starting date |
Main ID: NCT01812564
Date of registration: 6 February 2013 Last refreshed on: 13 March 2013 Date of first enrolment: November 2009 Status: recruiting participants |
| Contact information | Name: Johannes Tol, MD PhD Address: not reported Telephone: +97444132142 Email: johannes.tol@aspetar.com Affiliation: ASPETAR |
| Notes |