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

Doreen McClurg (Lead / Corresponding author), Kirsteen Goodman, Suzanne Hagen, Fiona Harris, Sean Treweek, Anton Emmanuel, Christine Norton, Maureen Coggrave, Selina Doran, John Norrie, Peter Donnan, Helen Mason, Sarkis Manoukian

    Research output: Contribution to journalArticlepeer-review

    6 Citations (Scopus)
    151 Downloads (Pure)

    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 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.

    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.

    Trial registration: ClinicalTrials.gov, ISRCTN85007023 . Registered on 10 June 2014.

    Original languageEnglish
    Article number150
    Pages (from-to)1-9
    Number of pages9
    JournalTrials
    Volume18
    DOIs
    Publication statusPublished - 29 Mar 2017

    Keywords

    • Journal article
    • Multiple sclerosis
    • Constipation
    • Abdominal massage
    • Randomised controlled trial

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