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; Kirsteen Goodman; Suzanne Hagen; Fiona Harris; Sean Treweek; Anton Emmanuel; Christine Norton; Maureen Coggrave; Selina Doran; John Norrie; Peter Donnan; Helen Mason; Sarkis Manoukian

doi:10.1186/s13063-017-1890-y

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 journal › Article › peer-review

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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 language	English
Article number	150
Pages (from-to)	1-9
Number of pages	9
Journal	Trials
Volume	18
DOIs	https://doi.org/10.1186/s13063-017-1890-y
Publication status	Published - 29 Mar 2017

Keywords

Journal article
Multiple sclerosis
Constipation
Abdominal massage
Randomised controlled trial

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10.1186/s13063-017-1890-yLicence: CC BY

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© The Author(s). 2017. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Final published version, 1.07 MBLicence: CC BY

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McClurg, D., Goodman, K., Hagen, S., Harris, F., Treweek, S., Emmanuel, A., Norton, C., Coggrave, M., Doran, S., Norrie, J., Donnan, P., 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, 1-9. Article 150. https://doi.org/10.1186/s13063-017-1890-y

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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 = "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.",

keywords = "Journal article, Multiple sclerosis , Constipation , Abdominal massage , Randomised controlled trial",

author = "Doreen McClurg and Kirsteen Goodman and Suzanne Hagen and Fiona Harris and Sean Treweek and Anton Emmanuel and Christine Norton and Maureen Coggrave and Selina Doran and John Norrie and Peter Donnan and Helen Mason and Sarkis Manoukian",

note = "The trial was funded by the United Kingdom National Health Service through the National Institute for Health Research Health Technology Assessment programme, open call project number HTA 12/127.",

year = "2017",

month = mar,

day = "29",

doi = "10.1186/s13063-017-1890-y",

language = "English",

volume = "18",

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McClurg, D, Goodman, K, Hagen, S, Harris, F, Treweek, S, Emmanuel, A, Norton, C, Coggrave, M, Doran, S, Norrie, J, Donnan, P, 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, vol. 18, 150, pp. 1-9. https://doi.org/10.1186/s13063-017-1890-y

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. / McClurg, Doreen (Lead / Corresponding author); Goodman, Kirsteen; Hagen, Suzanne et al.
In: Trials, Vol. 18, 150, 29.03.2017, p. 1-9.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Abdominal massage for neurogenic bowel dysfunction in people with multiple sclerosis (AMBER - Abdominal Massage for Bowel Dysfunction Effectiveness Research)

T2 - study protocol for a randomised controlled trial

AU - McClurg, Doreen

AU - Goodman, Kirsteen

AU - Hagen, Suzanne

AU - Harris, Fiona

AU - Treweek, Sean

AU - Emmanuel, Anton

AU - Norton, Christine

AU - Coggrave, Maureen

AU - Doran, Selina

AU - Norrie, John

AU - Donnan, Peter

AU - Mason, Helen

AU - Manoukian, Sarkis

N1 - The trial was funded by the United Kingdom National Health Service through the National Institute for Health Research Health Technology Assessment programme, open call project number HTA 12/127.

PY - 2017/3/29

Y1 - 2017/3/29

N2 - 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.

AB - 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.

KW - Journal article

KW - Multiple sclerosis

KW - Constipation

KW - Abdominal massage

KW - Randomised controlled trial

U2 - 10.1186/s13063-017-1890-y

DO - 10.1186/s13063-017-1890-y

M3 - Article

C2 - 28356133

SN - 1745-6215

VL - 18

SP - 1

EP - 9

JO - Trials

JF - Trials

M1 - 150

ER -

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

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