title: Randomised controlled study in the primary healthcare sector to investigate the effectiveness and safety of auriculotherapy for the treatment of uncomplicated chronic rachialgia: a study protocol.
abstract: BACKGROUND
  Uncomplicated chronic rachialgia is a highly prevalent complaint, and one for which therapeutic results are contradictory. The aim of the present study is to evaluate the effectiveness and safety of treatment with auriculopressure, in the primary healthcare sector, carried out by trained healthcare professionals via a 30-hour course.
  
  
  METHODS
  The design consists of a multi-centre randomized controlled trial, with placebo, with two parallel groups, and including an economic evaluation. Patients with chronic uncomplicated rachialgia, whose GP is considering referral for auriculopressure sensory stimulation, are eligible for inclusion. Sampling will be by consecutive selection, and randomised allocation to one of the two study arms will be determined using a centralised method, following a 1:1 plan (true auriculopressure; placebo auriculopressure). The implants (true and placebo) will be replaced once weekly, and the treatment will have a duration of 8 weeks. The primary outcome measure will be the change in pain intensity, measured on a visual analogue scale (VAS) of 100 mm, at 9 weeks after beginning the treatment. A follow up study will be performed at 6 months after beginning treatment. An assessment will also be made of the changes measured in the Spanish version of the McGill Pain Questionnaire, of the changes in the Lattinen test, and of the changes in quality of life (SF-12). Also planned is an analysis of cost-effectiveness and also, if necessary, a cost-benefit analysis.
  
  
  CONCLUSIONS
  This study will contribute to developing evidence on the use of auriculotherapy using Semen vaccariae [wang bu liu xing] for the treatment of uncomplicated chronic rachialgia.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN01897462.
authors.affiliation: Pain Treatment Unit, Primary Healthcare Centre, Dos Hermanas, Spain. jorgef.vas.sspa@juntadeandalucia.es
authors.forename: Jorge
authors.initials: J
authors.lastname: Vas
authors.forename: Inmaculada
authors.initials: I
authors.lastname: Aguilar
authors.forename: M Angeles
authors.initials: MA
authors.lastname: Campos
authors.forename: Camila
authors.initials: C
authors.lastname: Méndez
authors.forename: Emilio
authors.initials: E
authors.lastname: Perea-Milla
authors.forename: Manuela
authors.initials: M
authors.lastname: Modesto
authors.forename: Paloma
authors.initials: P
authors.lastname: Caro
authors.forename: Francisco
authors.initials: F
authors.lastname: Martos
authors.forename: Antonio J
authors.initials: AJ
authors.lastname: García-Ruiz
mesh_terms: D020831:Acupuncture, Ear / Q000191:economics* / Q000379:methods*; D000328:Adult; D001416:Back Pain / Q000191:economics* / Q000628:therapy*; D002908:Chronic Disease; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D011320:Primary Health Care / Q000191:economics* / Q000379:methods*; D012107:Research Design; D013122:Spinal Diseases / Q000191:economics / Q000628:therapy; D016896:Treatment Outcome