title: Shock wave therapy associated with eccentric strengthening versus isolated eccentric strengthening for Achilles insertional tendinopathy treatment: a double-blinded randomised clinical trial protocol.
abstract: There is no consensus regarding the treatment of Achilles insertional tendinopathies. Eccentric training remains the main choice in the conservative treatment of this illness; however, the good results in the management of non-insertional Achilles tendinopathy were not replicated in the insertional condition. Low energy shock wave therapy has been described as an alternative to these patients, but has yet to be empirically tested.
  
  
  
  Shock wave therapy, adjunctive to the eccentric strengthening protocol, will improve measures of pain and function.
  
  
  
  Double blind, placebo-controlled, parallel groups, randomised clinical trial.
  
  
  
  93 patients with a diagnosis of chronic insertional tendinopathy, referred from primary or secondary healthcare services, will be assessed and enrolled in this study. They will be divided into two groups (randomised by sequentially numbered identical envelopes, which will be administered serially to participants), one containing the combination of low energy shock wave and eccentric exercises, as treatment and the other comprehending the exercises and the placebo treatment (an apparatus placed in the therapeutic head). The assessments will occur in 2, 4, 6, 12 and 24 weeks. Patients will be evaluated primarily by the Victorian Institute of Sport Assessment-Achilles questionnaire and secondarily by the visual analogue scale, Algometry, the American Orthopedic Foot and Ankle Society scale, the Foot and Ankle Outcome Score and the 12-item Short Form Health Survey. We will use comparison of two proportions via relative frequency analysis, the Pearson Correlation the χ2test and the analysis of variance for statistical analyses.
  
  
  
  This study intends to demonstrate if the association of the eccentric exercise programme with the shock wave therapy can produce good results regarding the treatment of the Achilles insertional tendinopathy. In an attempt to prevent the high costs and complications associated with the surgical intervention, we will try to prove this combination as a viable therapeutic option in the conservative management of this prevalent condition. The strengths of the study are the design and the novelty of the combination of methods. The main limitation is the short follow-up course.
  
  
  
  The study is registered in the Clinical Trials database (protocol number: 8094833648737701) and was approved by the University Ethics Committee (number: 1373481).
  
  
  
  8094833648737701 (NCT02757664); Pre-results.
authors.affiliation: Department of Orthopaedics, Universidade Federal de Sao Paulo, Sao Paulo, SP, Brazil.
authors.forename: Nacime Salomão Barbachan
authors.initials: NS
authors.lastname: Mansur
authors.affiliation: Orthopedics and Traumatology-Division of Hand Surgery and Upper Limb, Federal University of São Paulo (UNIFESP/EPM), São Paulo, SP, Brazil.
authors.forename: Flávio
authors.initials: F
authors.lastname: Faloppa
authors.affiliation: Orthopedics and Traumatology-Division of Hand Surgery and Upper Limb, Federal University of São Paulo (UNIFESP/EPM), São Paulo, SP, Brazil.
authors.forename: João Carlos
authors.initials: JC
authors.lastname: Belloti
authors.affiliation: Department of Orthopaedics, Universidade Federal de Sao Paulo, Sao Paulo, SP, Brazil.
authors.forename: Sheila J McNeill
authors.initials: SJ
authors.lastname: Ingham
authors.affiliation: Orthopedics and Traumatology-Division of Hand Surgery and Upper Limb, Federal University of São Paulo (UNIFESP/EPM), São Paulo, SP, Brazil.
authors.forename: Fabio Teruo
authors.initials: FT
authors.lastname: Matsunaga
authors.affiliation: Department of Orthopaedics, Universidade Federal de Sao Paulo, Sao Paulo, SP, Brazil.
authors.forename: Paulo Roberto Dias Dos
authors.initials: PR
authors.lastname: Santos
authors.affiliation: Department of Orthopaedics, Universidade Federal de Sao Paulo, Sao Paulo, SP, Brazil.
authors.forename: Bruno Schiefer Dos
authors.initials: BS
authors.lastname: Santos
authors.affiliation: Department of Orthopaedics, Universidade Federal de Sao Paulo, Sao Paulo, SP, Brazil.
authors.forename: Oreste Lemos
authors.initials: OL
authors.lastname: Carrazzone
authors.affiliation: Department of Orthopaedics, Universidade Federal de Sao Paulo, Sao Paulo, SP, Brazil.
authors.forename: Gabriel
authors.initials: G
authors.lastname: Peixoto
authors.affiliation: Department of Orthopaedics, Universidade Federal de Sao Paulo, Sao Paulo, SP, Brazil.
authors.forename: Bruno Takeshi
authors.initials: BT
authors.lastname: Aoyama
authors.affiliation: Department of Orthopaedics, Universidade Federal de Sao Paulo, Sao Paulo, SP, Brazil.
authors.forename: Marcel Jun Sugawara
authors.initials: MJ
authors.lastname: Tamaoki
mesh_terms: D000125:Achilles Tendon; D000700:Analgesics / Q000627:therapeutic use; D002908:Chronic Disease; D017679:Cryotherapy; D004311:Double-Blind Method; D000074059:Extracorporeal Shockwave Therapy / Q000379:methods*; D006801:Humans; D055070:Resistance Training / Q000379:methods*; D052256:Tendinopathy / Q000534:rehabilitation*; D016896:Treatment Outcome
chemical_list: D000700:Analgesics
keywords: achilles; eccentric; insertional; shock wave; tendinopathy