Randomised controlled trial, process evaluation and economic analysis comparing abdominal massage plus advice to advice only for neurogenic bowel dysfunction

Research output: Contribution to journalArticle

Accepted/In press

View graph of relations

Original languageEnglish
JournalNIHR
StateAccepted/In press - 29 Mar 2018

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.

Keywords

  • abdominal massage , neurogenic bowel dysfunction, multiple sclerosis