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 (Corresponding Author), Kirsteen Goodman , Suzanne Hagen, Fional Harris, Shaun Treweek, Anton Emmanuel, Christine Norton, Maureen Coggrave, Selina Doran, John Norrie, Peter Donnan, Helen Mason, Sarkis Manoukian

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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 languageEnglish
Article number150
JournalTrials
Volume18
DOIs
Publication statusPublished - 29 Mar 2017

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Neurogenic Bowel
Massage
Multiple Sclerosis
Constipation
Randomized Controlled Trials
Research
Fecal Incontinence
Pamphlets
Sclerosis
Young Adult
Outcome Assessment (Health Care)
Costs and Cost Analysis

Cite this

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 (Corresponding Author); Goodman , Kirsteen ; Hagen, Suzanne ; Harris, Fional; Treweek, Shaun; Emmanuel, Anton ; Norton, Christine; Coggrave, Maureen ; Doran, Selina; Norrie, John; Donnan, Peter; Mason, Helen; Manoukian, Sarkis .

In: Trials, Vol. 18, 150, 29.03.2017.

Research output: Contribution to journalArticle

McClurg, Doreen ; Goodman , Kirsteen ; Hagen, Suzanne ; Harris, Fional ; Treweek, Shaun ; Emmanuel, Anton ; Norton, Christine ; Coggrave, Maureen ; Doran, Selina ; Norrie, John ; Donnan, Peter ; Mason, Helen ; Manoukian, Sarkis . / 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. In: Trials. 2017 ; Vol. 18.
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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 = "BackgroundMultiple 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/designThis 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.DiscussionThis 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 registrationClinicalTrials.gov, ISRCTN85007023. Registered on 10 June 2014.",
author = "Doreen McClurg and Kirsteen Goodman and Suzanne Hagen and Fional Harris and Shaun 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.",
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T1 - 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

AU - McClurg, Doreen

AU - Goodman , Kirsteen

AU - Hagen, Suzanne

AU - Harris, Fional

AU - Treweek, Shaun

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 - BackgroundMultiple 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/designThis 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.DiscussionThis 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 registrationClinicalTrials.gov, ISRCTN85007023. Registered on 10 June 2014.

AB - BackgroundMultiple 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/designThis 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.DiscussionThis 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 registrationClinicalTrials.gov, ISRCTN85007023. Registered on 10 June 2014.

U2 - 10.1186/s13063-017-1890-y

DO - 10.1186/s13063-017-1890-y

M3 - Article

VL - 18

JO - Trials

JF - Trials

SN - 1745-6215

M1 - 150

ER -