title: Effectiveness of De Qi during acupuncture for the treatment of tinnitus: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Acupuncture has been used in China to treat tinnitus for a long time. There is debate as to whether or not De Qi is a key factor in achieving the efficacy of acupuncture. However, there is no sufficient evidence obtained from randomized controlled trials to confirm the role of De Qi in the treatment of acupuncture for tinnitus. This study aims to identify the effect of De Qi for patients who receive acupuncture to alleviate tinnitus by a prospective, double-blind, randomized, sham-controlled trial.
  
  
  METHODS
  This study compares two acupuncture groups (with or without manipulation) in 292 patients with a history of subjective tinnitus. The trial will be conducted in the Teaching Hospital of Chengdu University of Traditional Chinese Medicine. In the study, the patients will be randomly assigned into two groups according to a computer-generated randomization list and assessed prior to treatment. Then, they will receive 5 daily sessions of 30 minutes each time for 4 consecutive weeks and undergo a 12-week follow-up phase. The administration of acupuncture follows the guidelines for clinical research on acupuncture (WHO Regional Publication, Western Pacific Series Number 15, 1995), and is performed double-blind by physicians well-trained in acupuncture. The measures of outcome include the subjective symptoms scores and quantitative sensations of De Qi evaluated by Visual Analog Scales (VAS) and the Chinese version of the 'modified' Massachusetts General Hospital Acupuncture Sensation Scale (C-MMASS). Furthermore, adverse events are recorded and analyzed. If any subjects are withdrawn from the trial, intention-to-treat analysis (ITT) and per-protocol (PP) analysis will be performed.
  
  
  CONCLUSIONS
  The key features of this trial include the randomization procedures, large sample and the standardized protocol to evaluate De Qi qualitatively and quantitatively in the treatment of acupuncture for tinnitus. The trial will be the first study with a high evidence level in China to assess the efficacy of De Qi in the treatment of tinnitus in a randomized, double-blind, sham-controlled manner.
  
  
  BACKGROUND
  Chinese Clinical Trial Registry: ChiCTR-TRC-14004720 (6 May 2014).
authors.affiliation: Department of Otorhinolaryngology, Head and Neck Surgery of the Teaching Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan Province 610072, PR China. wangxie-ctu@163.com.
authors.forename: Hui
authors.initials: H
authors.lastname: Xie
authors.forename: Xinrong
authors.initials: X
authors.lastname: Li
authors.forename: Jiaqin
authors.initials: J
authors.lastname: Lai
authors.forename: Yanan
authors.initials: Y
authors.lastname: Zhou
authors.forename: Caiying
authors.initials: C
authors.lastname: Wang
authors.forename: Jiao
authors.initials: J
authors.lastname: Liang
mesh_terms: D015670:Acupuncture Therapy / Q000379:methods*; D000293:Adolescent; D000328:Adult; D001306:Auditory Pathways / Q000503:physiopathology; D001307:Auditory Perception; D002681:China; D002985:Clinical Protocols; D004311:Double-Blind Method; D005260:Female; D006309:Hearing; D006784:Hospitals, Teaching; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D058748:Pain Perception; D017288:Pain Threshold; D011446:Prospective Studies; D011788:Quality of Life; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D014012:Tinnitus / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D016896:Treatment Outcome; D055815:Young Adult