title: N of 1, two contemporary arm, randomised controlled clinical trial for bilateral epicondylitis: a new study design.
abstract: OBJECTIVE
  To investigate the use of a novel study design in analysis of bilateral elbow pain.
  
  
  METHODS
  N of 1, two contemporary arm, open label, randomised controlled clinical trial.
  
  
  METHODS
  A clinical epidemiologist at a university hospital in Pavia, Italy.
  
  
  METHODS
  Two elbows with epicondylitis.
  
  
  METHODS
  Autologous platelet lysate versus "wait and see" strategy.
  
  
  METHODS
  Visual analogue scale for pain on elbow extension and resisted wrist extension.
  
  
  RESULTS
  Over six months' follow-up, the patient experienced bilateral improvement in pain, but higher in the treated arm, with a drop in visual analogue scale for pain from 28 to 4 for right (control) arm (drop of 24 points) and from 67 to 10.5 for left (treated) arm (drop of 56.5 points).
  
  
  CONCLUSIONS
  Platelet lysate might (or might not) work. Competing interests and lack of blinding might be relevant issues in the interpretation of trial results. However, the new study design can be applied to a number of conditions such as bilateral sport or trauma injuries, bilateral otitis, or any condition affecting chiral organs or limbs.
authors.affiliation: Fondazione IRCCS Policlinico San Matteo, Viale Golgi 2, 27100 Pavia, Italy. l.scudeller@smatteo.pv.it
authors.forename: Luigia
authors.initials: L
authors.lastname: Scudeller
authors.forename: Claudia
authors.initials: C
authors.lastname: Del Fante
authors.forename: Cesare
authors.initials: C
authors.lastname: Perotti
authors.forename: Claudio Francesco
authors.initials: CF
authors.lastname: Pavesi
authors.forename: Davide
authors.initials: D
authors.lastname: Coscia
authors.forename: Valeria
authors.initials: V
authors.lastname: Scotti
authors.forename: Carmine
authors.initials: C
authors.lastname: Tinelli
mesh_terms: D000305:Adrenal Cortex Hormones / Q000008:administration & dosage / Q000009:adverse effects; D000328:Adult; D032762:Autoexperimentation; D001792:Blood Platelets; D005260:Female; D006801:Humans; D007267:Injections; D007558:Italy; D010147:Pain Measurement; D053657:Platelet-Rich Plasma / Q000502:physiology; D012107:Research Design; D013716:Tennis Elbow / Q000503:physiopathology / Q000628:therapy*; D016896:Treatment Outcome; D057832:Watchful Waiting
chemical_list: D000305:Adrenal Cortex Hormones