title: Effects of acupuncture on patients with fibromyalgia: study protocol of a multicentre randomized controlled trial.
abstract: BACKGROUND
  Fibromyalgia is a multidimensional disorder for which treatment as yet remains unsatisfactory. Studies of an acupuncture-based approach, despite its broad acceptance among patients and healthcare staff, have not produced sufficient evidence of its effectiveness in treating this syndrome. The present study aims to evaluate the effectiveness of individualized acupuncture for patients with fibromyalgia, with respect to reducing their pain and level of incapacity, and improving their quality of life.
  
  
  METHODS
  Randomized controlled multicentre study, with 156 outpatients, aged over 17 years, diagnosed with fibromyalgia according to American College of Rheumatology criteria, either alone or associated with severe depression, according to the criteria of the Diagnostic and Statistical Manual for Mental Disorders. The participants will be randomly assigned to receive either "True acupuncture" or "Sham acupuncture". They will be evaluated using a specific measurement system, constituted of the Fibromyalgia Impact Questionnaire and the Hamilton rating scale for depression. Also taken into consideration will be the clinical and subjective pain intensity, the patient's family structure and relationships, psychological aspects, quality of life, the duration of previous temporary disability, the consumption of antidepressant, analgesic and anti-inflammatory medication, and the potential effect of factors considered to be predictors of a poor prognosis. All these aspects will be examined by questionnaires and other suitably-validated instruments. The results obtained will be analysed at 10 weeks, and 6 and 12 months from the start of treatment.
  
  
  CONCLUSIONS
  This trial will utilize high quality trial methodologies in accordance with CONSORT guidelines. It may provide evidence for the effectiveness of acupuncture as a treatment for fibromyalgia either alone or associated with severe depression.
  
  
  BACKGROUND
  ISRCTN trial number ISRCTN60217348 (19 October 2010).
authors.affiliation: Pain Treatment Unit, Doña Mercedes Primary Health Care Centre, Dos Hermanas, Spain. jorgef.vas.sspa@juntadeandalucia.es
authors.forename: Jorge
authors.initials: J
authors.lastname: Vas
authors.forename: Manuela
authors.initials: M
authors.lastname: Modesto
authors.forename: Inmaculada
authors.initials: I
authors.lastname: Aguilar
authors.forename: Koldo
authors.initials: K
authors.lastname: Santos-Rey
authors.forename: Nicolás
authors.initials: N
authors.lastname: Benítez-Parejo
authors.forename: Francisco
authors.initials: F
authors.lastname: Rivas-Ruiz
mesh_terms: D015670:Acupuncture Therapy; D003863:Depression / Q000175:diagnosis / Q000188:drug therapy / Q000209:etiology; D004185:Disability Evaluation; D005356:Fibromyalgia / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D006801:Humans; D010146:Pain / Q000209:etiology; D059408:Pain Management; D010147:Pain Measurement; D011788:Quality of Life; D020127:Recovery of Function; D012107:Research Design; D012720:Severity of Illness Index; D013030:Spain; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome