NCT01851044.
| Trial name or title | The effect of platelet rich plasma on lateral epicondylitis the treatment of lateral epicondylitis: the effect of platelet rich plasma on healing ‐ a randomised controlled double blinded trial |
| Methods | Study design: randomised controlled trial Random sequence generation: not reported Allocation concealment: not reported Masking: double blind (subject, investigator, outcome assessor) |
| Participants | Location: University of Tampere Target sample size (N): 120 Inclusion criteria: symptoms for > 3 months; primary conservative treatment (physiotherapy, NSAIDs etc.) has been tried Exclusion criteria: significant systemic diseases; any surgical operation on the affected elbow |
| Interventions |
PRP: 9 mL autologous venous blood centrifuged using the Arthrex ACP® Double Syringe System and 2 mL PRP injected to the proximal insertion of the extensor carpi radialis brevis muscle Controls or placebo or no intervention (standard care): saline injections (1 arm) and whole blood injections (1 arm) |
| Outcomes | Primary outcomes: pain (VAS scale) and DASH score Secondary outcomes: grip strength (Jamar); need for NSAIDs; duration of the potential sick leave due to lateral epicondylitis Timing of outcomes measurement: 52 weeks |
| Starting date |
Main ID: NCT01851044
Date of registration: May 2013 Last refreshed on: May 2013 Date of first enrolment: not reported Status: |
| Contact information | Name: Olli Leppänen Address: Hatanpää City Hospital, Tampere, Finland Telephone: +358 405 866581 Email: olli.v.leppanen@uta.fi Affiliation: University of Tampere |
| Notes |
Abbreviations
> = greater/more than < = less/fewer than ≥ = greater/more than or equal to ≤ = less/fewer than or equal to ACL = anterior cruciate ligament ACP = autologous conditioned plasma ASES = American Shoulder and Elbow Surgeons' scoring system ASPETAR = Qatar's Orthopaedic and Sports Medicine Hospital BMI = body:mass index CM = Constant‐Murley score DASH = Disabilities of the Arm Shoulder and Hand questionnaire EQ‐5D = Euroqol 5D a standardised instrument for measuring quality of life HADS = Hospital Anxiety and Depression Scale Hgb = haemoglobin LEFS = Lower extremity Function Scale MRI = magnetic resonance imaging NCS = numeric rating scale NSAIDs = non‐steroidal anti‐inflammatories PPP = platelet poor plasma PRP = platelet‐rich plasma SF‐12 = the Short Form health survey SLAP = Superior Labral Anterior and Posterior lesions US = ultrasound VAS = visual analogue scale VISA‐A = Victorian Institute of Sports Assessment ‐ Achilles questionnaire WORC = Western Ontario Rotator Cuff outcome measure