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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

Citation
McClurg D, Goodman K, Hagen S, Harris FM, Treweek S, Emmanuel A, Norton C, Coggrave M, Doran S, Norrie J, Donnan PT, Mason H & Manoukian S (2017) 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, Trials, 18, Art. No.: 150.

Abstract
Background 

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. 
Methods/design 
This is a multi-centred patient randomised superiority trial comparing an experimental strategy of once daily abdominal massage for 6weeks 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 24weeks. 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. 
Discussion 
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.

Keywords
Multiple sclerosis; Constipation; Abdominal massage; Randomised controlled trial

StatusPublished
AuthorsMcClurg Doreen, Goodman Kirsteen, Hagen Suzanne, Harris Fiona Margaret, Treweek Shaun, Emmanuel Anton, Norton Christine, Coggrave Maureen, Doran Selina, Norrie John, Donnan Peter T, Mason Helen, Manoukian Sarkis
Publication date29/03/2017
Publication date online29/03/2017
Date accepted by journal10/03/2017
PublisherBioMed Central
ISSN 1745-6215
LanguageEnglish

Journal
Trials: Volume 18 (2017)

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