title: Development of a manualized protocol of massage therapy for clinical trials in osteoarthritis.
abstract: BACKGROUND
  Clinical trial design of manual therapies may be especially challenging as techniques are often individualized and practitioner-dependent. This paper describes our methods in creating a standardized Swedish massage protocol tailored to subjects with osteoarthritis of the knee while respectful of the individualized nature of massage therapy, as well as implementation of this protocol in two randomized clinical trials.
  
  
  METHODS
  The manualization process involved a collaborative process between methodologic and clinical experts, with the explicit goals of creating a reproducible semi-structured protocol for massage therapy, while allowing some latitude for therapists' clinical judgment and maintaining consistency with a prior pilot study.
  
  
  RESULTS
  The manualized protocol addressed identical specified body regions with distinct 30- and 60-min protocols, using standard Swedish strokes. Each protocol specifies the time allocated to each body region. The manualized 30- and 60-min protocols were implemented in a dual-site 24-week randomized dose-finding trial in patients with osteoarthritis of the knee, and is currently being implemented in a three-site 52-week efficacy trial of manualized Swedish massage therapy. In the dose-finding study, therapists adhered to the protocols and significant treatment effects were demonstrated.
  
  
  CONCLUSIONS
  The massage protocol was manualized, using standard techniques, and made flexible for individual practitioner and subject needs. The protocol has been applied in two randomized clinical trials. This manualized Swedish massage protocol has real-world utility and can be readily utilized both in the research and clinical settings.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT00970008 (18 August 2009).
authors.affiliation: Department of Pediatrics, Yale University School of Medicine, 2 Church Street South, New Haven, CT 06519, USA. ather.ali@yale.edu
authors.forename: Ather
authors.initials: A
authors.lastname: Ali
authors.forename: Janet
authors.initials: J
authors.lastname: Kahn
authors.forename: Lisa
authors.initials: L
authors.lastname: Rosenberger
authors.forename: Adam I
authors.initials: AI
authors.lastname: Perlman
mesh_terms: D002985:Clinical Protocols / Q000592:standards; D006801:Humans; D007719:Knee Joint / Q000503:physiopathology*; D008405:Massage / Q000379:methods* / Q000592:standards; D009515:New Jersey; D020370:Osteoarthritis, Knee / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D012107:Research Design / Q000592:standards; D013997:Time Factors; D016896:Treatment Outcome