title: Abdominal massage for neurogenic bowel dysfunction in people with multiple sclerosis (AMBER - Abdominal Massage for Bowel Dysfunction Effectiveness Research): study protocol for a randomised controlled trial.
abstract: Multiple sclerosis (MS) is a life-long condition primarily affecting younger adults. Neurogenic bowel dysfunction (NBD) occurs in 50-80% of these patients and is the term used to describe constipation and faecal incontinence, which often co-exist. Data from a pilot study suggested feasibility of using abdominal massage for the relief of constipation, but the effectiveness remains uncertain.
  
  
  
  This is a multi-centred patient randomised superiority trial comparing an experimental strategy of once daily abdominal massage for 6 weeks against a control strategy of no massage in people with MS who have stated that their constipation is bothersome. The primary outcome is the Neurogenic Bowel Dysfunction Score at 24 weeks. Both groups will receive optimised advice plus the MS Society booklet on bowel management in MS, and will continue to receive usual care. Participants and their clinicians will not be blinded to the allocated intervention. Outcome measures are primarily self-reported and submitted anonymously. Central trial staff who will manage and analyse the trial data will be unaware of participant allocations. Analysis will follow intention-to-treat principles.
  
  
  
  This pragmatic randomised controlled trial will demonstrate if abdominal massage is an effective, cost-effective and viable addition to the treatment of NBD in people with MS.
  
  
  
  ClinicalTrials.gov, ISRCTN85007023 . Registered on 10 June 2014.
authors.affiliation: NMAHP RU, Glasgow Caledonian University, A603 Govan Mbeki Building, Glasgow, G4 0BA, UK. Doreen.mcclurg@gcu.ac.uk.
authors.forename: Doreen
authors.identifier: 0000-0002-2872-1702
authors.initials: D
authors.lastname: McClurg
authors.affiliation: NMAHP RU, Glasgow Caledonian University, A603 Govan Mbeki Building, Glasgow, G4 0BA, UK.
authors.forename: Kirsteen
authors.initials: K
authors.lastname: Goodman
authors.affiliation: NMAHP RU, Glasgow Caledonian University, A603 Govan Mbeki Building, Glasgow, G4 0BA, UK.
authors.forename: Suzanne
authors.initials: S
authors.lastname: Hagen
authors.affiliation: NMAHP RU, Stirling University, Stirling, UK.
authors.forename: Fional
authors.initials: F
authors.lastname: Harris
authors.affiliation: Centre for Healthcare Randomised Trials (CHaRT) Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
authors.forename: Sean
authors.initials: S
authors.lastname: Treweek
authors.affiliation: University College Hospital, University College London, London, UK.|National Hospital for Neurology and Neurosurgery, University College London, London, UK.
authors.forename: Anton
authors.initials: A
authors.lastname: Emmanuel
authors.affiliation: King's College London, London University College, London, UK.
authors.forename: Christine
authors.initials: C
authors.lastname: Norton
authors.affiliation: King's College London, London University College, London, UK.
authors.forename: Maureen
authors.initials: M
authors.lastname: Coggrave
authors.affiliation: NMAHP RU, Glasgow Caledonian University, A603 Govan Mbeki Building, Glasgow, G4 0BA, UK.
authors.forename: Selina
authors.initials: S
authors.lastname: Doran
authors.affiliation: Centre for Healthcare Randomised Trials (CHaRT) Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
authors.forename: John
authors.initials: J
authors.lastname: Norrie
authors.affiliation: Tayside Clinical Trials Unit, University of Dundee, Dundee, UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Donnan
authors.affiliation: Yunus Centre for Social Business and Health, Glasgow Caledonian University, Glasgow, UK.
authors.forename: Helen
authors.initials: H
authors.lastname: Mason
authors.affiliation: Yunus Centre for Social Business and Health, Glasgow Caledonian University, Glasgow, UK.
authors.forename: Sarkis
authors.initials: S
authors.lastname: Manoukian
mesh_terms: D000005:Abdomen; D002985:Clinical Protocols; D003248:Constipation / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D003672:Defecation; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D007422:Intestines / Q000294:innervation*; D008297:Male; D008405:Massage / Q000379:methods*; D009103:Multiple Sclerosis / Q000150:complications* / Q000175:diagnosis / Q000503:physiopathology; D055496:Neurogenic Bowel / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D020127:Recovery of Function; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom
keywords: Abdominal massage; Constipation; Multiple sclerosis; Randomised controlled trial