title: Using a partially randomized patient preference study design to evaluate the therapeutic effect of acupuncture and cupping therapy for fibromyalgia: study protocol for a partially randomized controlled trial.
abstract: BACKGROUND
  Conducting randomized controlled trials on traditional Chinese non-drug therapies has been limited by factors such as patient preference to specific treatment modality. The aim of this study is to investigate the feasibility of applying a partially randomized patient preference (PRPP) trial model in evaluating the efficacy of two types of traditional Chinese medicine therapies, acupuncture and cupping, for fibromyalgia while accounting for patients' preference of either therapeutic modality.
  
  
  METHODS
  This protocol was approved by the Institutional Ethics Committee of affiliated Dongfang Hospital, Beijing University of Chinese Medicine (approval number: 2013052104-2). One hundred participants with fibromyalgia will be included in this study. Diagnosis of fibromyalgia will be based on the American College of Rheumatology criteria. Before treatment, participants will be interviewed for their preference toward acupuncture or cupping therapy. Fifty participants with no preference will be randomly assigned to one of the two groups and another 50 participants with strong preference to either acupuncture or cupping will receive what they choose. For acupuncture and cupping therapy, the main acupoints used will be tender points (Ashi). Treatment will be three times a week for 5 consecutive weeks with a follow-up period of 12 weeks. Outcome measures will be qualitative (patient expectation and satisfaction) and quantitative (pain intensity, quality of life, depression assessment).
  
  
  BACKGROUND
  NCT01869712 (in clinicaltrials.gov, on 22nd May 2013).
authors.affiliation: Beijing University of Chinese Medicine, Bei San Huan Dong Lu 11, Chaoyang District, Beijing 100029, China. huijuancao327@hotmail.com.
authors.forename: Hui-Juan
authors.initials: HJ
authors.lastname: Cao
authors.forename: Jian-Ping
authors.initials: JP
authors.lastname: Liu
authors.forename: Hui
authors.initials: H
authors.lastname: Hu
authors.forename: Nissi S
authors.initials: NS
authors.lastname: Wang
mesh_terms: D015670:Acupuncture Therapy; D002681:China; D002985:Clinical Protocols; D003863:Depression / Q000523:psychology / Q000628:therapy; D005240:Feasibility Studies; D005356:Fibromyalgia / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D006801:Humans; D008516:Medicine, Chinese Traditional / Q000379:methods*; D010147:Pain Measurement; D057240:Patient Preference; D017060:Patient Satisfaction; D018579:Patient Selection; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome