Abdominal massage plus advice, compared with advice only, for neurogenic bowel dysfunction in MS: a RCT

Doreen McClurg, Fiona Harris, Kirsteen Goodman, Selina Doran, Suzanne Hagen, Shaun Treweek, Christine Norton, Maureen Coggrave, John Norrie, Petra Rauchhaus, Peter Donnan, Anton Emmanuel, Sarkis Manoukian, Helen Mason

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Abstract

Background: 50-80% of people with multiple sclerosis (PwMS) experience neurogenic bowel dysfunction (NBD - constipation and faecal incontinence) which impacts on quality of life and can lead to hospitalisation.

Objectives: To determine the effectiveness and cost effectiveness of abdominal massage plus advice on bowel symptoms on PwMS compared to advice only. A process evaluation investigated factors that impacted upon effectiveness and possible implementation.

Design: A randomised controlled trial with process evaluation and health economic components. Outcome analysis was undertaken blind.

Setting: 12 UK hospitals in the
Participants: PwMS who had ‘bothersome’ NBD


Intervention: Following individualised training, abdominal massage was undertaken daily for 6 weeks (Intervention Group). Advice on good bowel management as per the MS Society Advice Booklet was provided to both groups. All participants received weekly telephone calls from the research nurse.

Main Outcome Measures: The primary outcome was the difference between the Intervention and Control Groups in change in the Neurogenic Bowel Dysfunction (NBD) Score from Baseline to Week 24. Secondary outcomes were measured via a bowel diary, adherence diary, the Constipation Scoring System, patient resource questionnaire and the EQ-5D-5L.

Results: 189 participants were randomised (99 in the control and 90 in the intervention group) and intention-to-treat analysis performed. Mean age was 52 years (SD 10.83), 81% (n=154) were female, 11% (n=21) were wheelchair dependent. Fifteen from the Intervention Group and five from the Control Group were lost to follow up.

The change in NBD Score by Week 24 demonstrated no significant difference between Groups (mean difference total score -1.64, 95% CI -3.32 to 0.04, p=0.0558); there was a

significant difference between groups in change in the frequency of stool evacuation per week (mean difference 0.62, 95% CI 0.03 to 1.21, p=0.039), and in the number of times per week participants felt they emptied their bowels completely (mean difference 1.08, 95% CI
0.41 to 1.76, p=0.002) in favour of the Intervention Group.
Three-quarters of participant interviewees reported benefits e.g. less difficulty passing stool, more complete evacuations, less bloated, improved appetite, and 85% continued with the massage. A cost utility analysis conducted from an NHS and patient cost perspective found in the imputed sample with bootstrapping a mean incremental outcome effect of the intervention relative to usual care of -.002 QALYs (95% CI -.029 to .027). In the same imputed sample with bootstrapping the mean incremental cost effect of the intervention relative to usual care was £56.50 (95% CI -372.62 to £415.68).
No adverse events were reported. Limitations include unequal randomisation and drop-out, and the possibility of ineffective massage technique.

Conclusion: The increment in the primary outcome favoured the intervention group but it was small and not statistically significant and the economic analysis identified that the intervention was dominated by the control group. Given the small improvement in the primary outcome, but not in terms of QUALYS, a low cost version of the intervention might be considered worthwhile by some patients.

Future Work: Research is required to establish possible mechanisms of action and modes of massage delivery.
Original languageEnglish
Number of pages166
JournalHealth Technology Assessment
Volume22
Issue number58
DOIs
Publication statusPublished - 31 Oct 2018

Fingerprint

Neurogenic Bowel
Massage
Multiple Sclerosis
Cost-Benefit Analysis
Constipation
Costs and Cost Analysis
Control Groups
Fecal Incontinence
Pamphlets
Wheelchairs
Intention to Treat Analysis
Quality-Adjusted Life Years
Lost to Follow-Up
Appetite
Random Allocation
Research
Telephone
Hospitalization
Randomized Controlled Trials
Nurses

Keywords

  • abdominal massage
  • neurogenic bowel dysfunction
  • multiple sclerosis

Cite this

McClurg, Doreen ; Harris, Fiona ; Goodman, Kirsteen ; Doran, Selina ; Hagen, Suzanne ; Treweek, Shaun ; Norton, Christine ; Coggrave, Maureen ; Norrie, John ; Rauchhaus, Petra ; Donnan, Peter ; Emmanuel, Anton ; Manoukian, Sarkis ; Mason, Helen. / Abdominal massage plus advice, compared with advice only, for neurogenic bowel dysfunction in MS: a RCT. In: Health Technology Assessment. 2018 ; Vol. 22, No. 58.
@article{3df943c9d0054e35a1b3229c6e387eb8,
title = "Abdominal massage plus advice, compared with advice only, for neurogenic bowel dysfunction in MS: a RCT",
abstract = "Background: 50-80{\%} of people with multiple sclerosis (PwMS) experience neurogenic bowel dysfunction (NBD - constipation and faecal incontinence) which impacts on quality of life and can lead to hospitalisation.Objectives: To determine the effectiveness and cost effectiveness of abdominal massage plus advice on bowel symptoms on PwMS compared to advice only. A process evaluation investigated factors that impacted upon effectiveness and possible implementation.Design: A randomised controlled trial with process evaluation and health economic components. Outcome analysis was undertaken blind.Setting: 12 UK hospitals in theParticipants: PwMS who had ‘bothersome’ NBDIntervention: Following individualised training, abdominal massage was undertaken daily for 6 weeks (Intervention Group). Advice on good bowel management as per the MS Society Advice Booklet was provided to both groups. All participants received weekly telephone calls from the research nurse.Main Outcome Measures: The primary outcome was the difference between the Intervention and Control Groups in change in the Neurogenic Bowel Dysfunction (NBD) Score from Baseline to Week 24. Secondary outcomes were measured via a bowel diary, adherence diary, the Constipation Scoring System, patient resource questionnaire and the EQ-5D-5L.Results: 189 participants were randomised (99 in the control and 90 in the intervention group) and intention-to-treat analysis performed. Mean age was 52 years (SD 10.83), 81{\%} (n=154) were female, 11{\%} (n=21) were wheelchair dependent. Fifteen from the Intervention Group and five from the Control Group were lost to follow up.The change in NBD Score by Week 24 demonstrated no significant difference between Groups (mean difference total score -1.64, 95{\%} CI -3.32 to 0.04, p=0.0558); there was a significant difference between groups in change in the frequency of stool evacuation per week (mean difference 0.62, 95{\%} CI 0.03 to 1.21, p=0.039), and in the number of times per week participants felt they emptied their bowels completely (mean difference 1.08, 95{\%} CI0.41 to 1.76, p=0.002) in favour of the Intervention Group.Three-quarters of participant interviewees reported benefits e.g. less difficulty passing stool, more complete evacuations, less bloated, improved appetite, and 85{\%} continued with the massage. A cost utility analysis conducted from an NHS and patient cost perspective found in the imputed sample with bootstrapping a mean incremental outcome effect of the intervention relative to usual care of -.002 QALYs (95{\%} CI -.029 to .027). In the same imputed sample with bootstrapping the mean incremental cost effect of the intervention relative to usual care was £56.50 (95{\%} CI -372.62 to £415.68).No adverse events were reported. Limitations include unequal randomisation and drop-out, and the possibility of ineffective massage technique.Conclusion: The increment in the primary outcome favoured the intervention group but it was small and not statistically significant and the economic analysis identified that the intervention was dominated by the control group. Given the small improvement in the primary outcome, but not in terms of QUALYS, a low cost version of the intervention might be considered worthwhile by some patients.Future Work: Research is required to establish possible mechanisms of action and modes of massage delivery.",
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Abdominal massage plus advice, compared with advice only, for neurogenic bowel dysfunction in MS: a RCT. / McClurg, Doreen; Harris, Fiona; Goodman, Kirsteen; Doran, Selina; Hagen, Suzanne; Treweek, Shaun; Norton, Christine; Coggrave, Maureen; Norrie, John; Rauchhaus, Petra ; Donnan, Peter; Emmanuel, Anton; Manoukian, Sarkis; Mason, Helen.

In: Health Technology Assessment, Vol. 22, No. 58, 31.10.2018.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Abdominal massage plus advice, compared with advice only, for neurogenic bowel dysfunction in MS: a RCT

AU - McClurg, Doreen

AU - Harris, Fiona

AU - Goodman, Kirsteen

AU - Doran, Selina

AU - Hagen, Suzanne

AU - Treweek, Shaun

AU - Norton, Christine

AU - Coggrave, Maureen

AU - Norrie, John

AU - Rauchhaus, Petra

AU - Donnan, Peter

AU - Emmanuel, Anton

AU - Manoukian, Sarkis

AU - Mason, Helen

N1 - Acceptance in SAN Query to author re expected pub date, not found online ET 29/7/19 > transpires that paper published in Oct 2018, with different title to that on AAM. Title field amended. >> AAM title =" Randomised controlled trial, process evaluation and economic analysis comparing abdominal massage plus advice to advice only for neurogenic bowel dysfunction" 9/8/19 DC Pub date - used last date in month as full pub date needed by Pure. ET 18/11/19 Note non-compliance result - due to access requirement (0 embargo). ET Applied 'no exception' as issue was access date for zero embargo. ET 18/11/19

PY - 2018/10/31

Y1 - 2018/10/31

N2 - Background: 50-80% of people with multiple sclerosis (PwMS) experience neurogenic bowel dysfunction (NBD - constipation and faecal incontinence) which impacts on quality of life and can lead to hospitalisation.Objectives: To determine the effectiveness and cost effectiveness of abdominal massage plus advice on bowel symptoms on PwMS compared to advice only. A process evaluation investigated factors that impacted upon effectiveness and possible implementation.Design: A randomised controlled trial with process evaluation and health economic components. Outcome analysis was undertaken blind.Setting: 12 UK hospitals in theParticipants: PwMS who had ‘bothersome’ NBDIntervention: Following individualised training, abdominal massage was undertaken daily for 6 weeks (Intervention Group). Advice on good bowel management as per the MS Society Advice Booklet was provided to both groups. All participants received weekly telephone calls from the research nurse.Main Outcome Measures: The primary outcome was the difference between the Intervention and Control Groups in change in the Neurogenic Bowel Dysfunction (NBD) Score from Baseline to Week 24. Secondary outcomes were measured via a bowel diary, adherence diary, the Constipation Scoring System, patient resource questionnaire and the EQ-5D-5L.Results: 189 participants were randomised (99 in the control and 90 in the intervention group) and intention-to-treat analysis performed. Mean age was 52 years (SD 10.83), 81% (n=154) were female, 11% (n=21) were wheelchair dependent. Fifteen from the Intervention Group and five from the Control Group were lost to follow up.The change in NBD Score by Week 24 demonstrated no significant difference between Groups (mean difference total score -1.64, 95% CI -3.32 to 0.04, p=0.0558); there was a significant difference between groups in change in the frequency of stool evacuation per week (mean difference 0.62, 95% CI 0.03 to 1.21, p=0.039), and in the number of times per week participants felt they emptied their bowels completely (mean difference 1.08, 95% CI0.41 to 1.76, p=0.002) in favour of the Intervention Group.Three-quarters of participant interviewees reported benefits e.g. less difficulty passing stool, more complete evacuations, less bloated, improved appetite, and 85% continued with the massage. A cost utility analysis conducted from an NHS and patient cost perspective found in the imputed sample with bootstrapping a mean incremental outcome effect of the intervention relative to usual care of -.002 QALYs (95% CI -.029 to .027). In the same imputed sample with bootstrapping the mean incremental cost effect of the intervention relative to usual care was £56.50 (95% CI -372.62 to £415.68).No adverse events were reported. Limitations include unequal randomisation and drop-out, and the possibility of ineffective massage technique.Conclusion: The increment in the primary outcome favoured the intervention group but it was small and not statistically significant and the economic analysis identified that the intervention was dominated by the control group. Given the small improvement in the primary outcome, but not in terms of QUALYS, a low cost version of the intervention might be considered worthwhile by some patients.Future Work: Research is required to establish possible mechanisms of action and modes of massage delivery.

AB - Background: 50-80% of people with multiple sclerosis (PwMS) experience neurogenic bowel dysfunction (NBD - constipation and faecal incontinence) which impacts on quality of life and can lead to hospitalisation.Objectives: To determine the effectiveness and cost effectiveness of abdominal massage plus advice on bowel symptoms on PwMS compared to advice only. A process evaluation investigated factors that impacted upon effectiveness and possible implementation.Design: A randomised controlled trial with process evaluation and health economic components. Outcome analysis was undertaken blind.Setting: 12 UK hospitals in theParticipants: PwMS who had ‘bothersome’ NBDIntervention: Following individualised training, abdominal massage was undertaken daily for 6 weeks (Intervention Group). Advice on good bowel management as per the MS Society Advice Booklet was provided to both groups. All participants received weekly telephone calls from the research nurse.Main Outcome Measures: The primary outcome was the difference between the Intervention and Control Groups in change in the Neurogenic Bowel Dysfunction (NBD) Score from Baseline to Week 24. Secondary outcomes were measured via a bowel diary, adherence diary, the Constipation Scoring System, patient resource questionnaire and the EQ-5D-5L.Results: 189 participants were randomised (99 in the control and 90 in the intervention group) and intention-to-treat analysis performed. Mean age was 52 years (SD 10.83), 81% (n=154) were female, 11% (n=21) were wheelchair dependent. Fifteen from the Intervention Group and five from the Control Group were lost to follow up.The change in NBD Score by Week 24 demonstrated no significant difference between Groups (mean difference total score -1.64, 95% CI -3.32 to 0.04, p=0.0558); there was a significant difference between groups in change in the frequency of stool evacuation per week (mean difference 0.62, 95% CI 0.03 to 1.21, p=0.039), and in the number of times per week participants felt they emptied their bowels completely (mean difference 1.08, 95% CI0.41 to 1.76, p=0.002) in favour of the Intervention Group.Three-quarters of participant interviewees reported benefits e.g. less difficulty passing stool, more complete evacuations, less bloated, improved appetite, and 85% continued with the massage. A cost utility analysis conducted from an NHS and patient cost perspective found in the imputed sample with bootstrapping a mean incremental outcome effect of the intervention relative to usual care of -.002 QALYs (95% CI -.029 to .027). In the same imputed sample with bootstrapping the mean incremental cost effect of the intervention relative to usual care was £56.50 (95% CI -372.62 to £415.68).No adverse events were reported. Limitations include unequal randomisation and drop-out, and the possibility of ineffective massage technique.Conclusion: The increment in the primary outcome favoured the intervention group but it was small and not statistically significant and the economic analysis identified that the intervention was dominated by the control group. Given the small improvement in the primary outcome, but not in terms of QUALYS, a low cost version of the intervention might be considered worthwhile by some patients.Future Work: Research is required to establish possible mechanisms of action and modes of massage delivery.

KW - abdominal massage

KW - neurogenic bowel dysfunction

KW - multiple sclerosis

U2 - 10.3310/hta22580

DO - 10.3310/hta22580

M3 - Article

VL - 22

JO - Health Technology Assessment

JF - Health Technology Assessment

SN - 1366-5278

IS - 58

ER -