title: Moxibustion for the treatment of pressure ulcers: study protocol for a pilot, multicentre, randomised controlled trial.
abstract: BACKGROUND
  Pressure ulcers are common in the elderly and immobile. Currently, there are few proven effective treatments for pressure ulcers. This trial aims to evaluate the feasibility, efficacy and safety of moxibustion for pressure ulcers.
  
  
  METHODS
  This is a multicentre, two-armed, parallel-design randomised controlled trial (RCT). 30 eligible patients with pressure ulcers will be randomised in a ratio of 1:1 to the treatment group and control group. The participants in the treatment group will undergo indirect moxibustion for 30 min before application of a dressing, one session daily, five sessions weekly for 4 weeks. The patients in the control group will only receive a dressing, applied in the same way as in the treatment group. Both groups will be followed up for 3 months. The primary outcome measures will be wound surface area (WSA) and proportion of ulcers healed within trial period (PUHTP). The secondary outcomes will be the Pressure Ulcer Scale for Healing (PUSH Tool), visual analogue scale (VAS) and adverse events. All outcomes will be evaluated at the beginning of the study, at the end of the second week, at 4 weeks after randomisation and at 1 and 3 months after treatment cessation.
  This trial has undergone ethical scrutiny and been approved by the ethics review boards of First Affiliated Hospital of Heilongjiang University of Chinese Medicine and Second Affiliated Hospital of Heilongjiang University of Chinese Medicine (Permission number: HZYEYLP2014). The results of this study will provide clinical evidence for the feasibility, efficacy and safety of moxibustion for pressure ulcers.
  
  
  BACKGROUND
  ChiCTR-TRC-13003959.
authors.affiliation: Department of Acupuncture and Moxibustion, Second Affiliated Hospital of Heilongjiang University of Chinese Medicine, Harbin, People's Republic of China.
authors.forename: Qin-hong
authors.initials: QH
authors.lastname: Zhang
authors.affiliation: Department of Acupuncture and Moxibustion, First Affiliated Hospital of Heilongjiang University of Chinese Medicine, Harbin, People's Republic of China.
authors.forename: Jin-huan
authors.initials: JH
authors.lastname: Yue
authors.affiliation: Department of Acupuncture and Moxibustion, Second Affiliated Hospital of Heilongjiang University of Chinese Medicine, Harbin, People's Republic of China.
authors.forename: Chao-ran
authors.initials: CR
authors.lastname: Li
authors.affiliation: Department of Acupuncture and Moxibustion, Second Affiliated Hospital of Heilongjiang University of Chinese Medicine, Harbin, People's Republic of China Department of Acupuncture and Moxibustion, First Affiliated Hospital of Heilongjiang University of Chinese Medicine, Harbin, People's Republic of China.
authors.forename: Zhong-ren
authors.initials: ZR
authors.lastname: Sun
mesh_terms: D000328:Adult; D001458:Bandages; D006801:Humans; D009071:Moxibustion; D010865:Pilot Projects; D003668:Pressure Ulcer / Q000628:therapy*; D012107:Research Design; D012867:Skin / Q000473:pathology*; D016896:Treatment Outcome; D014945:Wound Healing
keywords: WOUND MANAGEMENT; bedsores; moxibustion; pressure ulcers; randomized controlled trial