title: Efficacy and safety of ginger-salt-indirect moxibustion for urge urinary incontinence after stroke: protocol for a pilot multicentre randomised controlled trial.
abstract: BACKGROUND
  Ginger-salt-indirect moxibustion is widely applied to treat urge urinary incontinence after stroke, which is a common complication in stroke survivors. Moxa cone moxibustion and moxa box moxibustion are the main techniques of ginger-salt-indirect moxibustion. Our previous study had shown that ginger-salt-indirect moxibustion using moxa cones was feasible and effective for urination disorders post-stroke. This pilot study aims to assess the feasibility of conducting research to evaluate the efficacy and safety of ginger-salt-indirect moxibustion for patients with post-stroke urge urinary incontinence.
  
  
  METHODS
  This is a multicentre, prospective, single-blinded, pilot randomised controlled trial. 120 eligible patients will be randomly allocated to three groups. Treatment group A (n=40) will receive moxa cone moxibustion and routine care; treatment group B (n=40) will receive moxa box moxibustion and routine care; control group (n=40) will only receive routine care for stroke recovery. The entire moxibustion treatment will consist of a total of 28 sessions during the course of 4 weeks. The primary outcome measure will be the increase in mean volume per void assessed at week 4 from the first moxibustion session (baseline). Secondary outcome measures will include mean frequency of urination per day and quality of life assessments measured by completion of the Incontinence Quality of Life Questionnaire and Barthel Index. All outcome measures will be assessed at baseline and at 4 and 16 weeks from baseline. Adverse events in the three groups will be recorded to assess the safety of moxibustion.
  
  
  BACKGROUND
  Research ethics was approved by the Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine Affiliated to the Capital Medical University (ref: 2013BL-094). Written informed consent will be obtained from all participants. Study results will be published in peer reviewed journals.
  
  
  BACKGROUND
  ISRCTN 44706974.
authors.affiliation: Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing, China.
authors.forename: Linpeng
authors.initials: L
authors.lastname: Wang
authors.affiliation: Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing, China.
authors.forename: Lichen
authors.initials: L
authors.lastname: Wang
authors.affiliation: Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing, China.
authors.forename: Guangxia
authors.initials: G
authors.lastname: Shi
authors.affiliation: Research Center of Clinical Epidemiology Affiliated to Peking University, Beijing, China.
authors.forename: Lin
authors.initials: L
authors.lastname: Zeng
authors.affiliation: Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing, China.
authors.forename: Yi
authors.initials: Y
authors.lastname: Yang
authors.affiliation: Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing, China.
authors.forename: Tao
authors.identifier: http://orcid.org/0000-0002-8349-9091
authors.initials: T
authors.lastname: Zhang
authors.affiliation: Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing, China.
authors.forename: Huilin
authors.initials: H
authors.lastname: Liu
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D020939:Zingiber officinale; D006801:Humans; D008297:Male; D008875:Middle Aged; D009071:Moxibustion / Q000009:adverse effects / Q000379:methods*; D010865:Pilot Projects; D016037:Single-Blind Method; D012965:Sodium Chloride; D020521:Stroke / Q000150:complications*; D016896:Treatment Outcome; D053202:Urinary Incontinence, Urge / Q000209:etiology / Q000628:therapy*
chemical_list: D012965:Sodium Chloride