Title: Abdominal massage for neurogenic bowel dysfunction in people with multiple sclerosis (AMBER Abdominal Massage for Bowel Dysfunction Effectiveness Research)
Funder: Chief Scientist Office (Scotland)

Abstract: Background: Neurogenic bowel dysfunction (NBD: constipation and/or faecal incontinence) is common in people with multiple sclerosis (MS) and is rated as the most severe impact of their disease/injury above wheelchair dependence(26). Despite this intervention options are limited poorly evaluated and complex. We offer robust research into an inexpensive adjunct to self-management. Design: A parallel group RCT based on a previous pilot study comparing abdominal massage and optimised bowel care (n=100) to optimised bowel care alone (n=100) in people with MS who have NBD. A Process evaluation component will follow a longitudinal case study design (4 5) which will explore 1)fidelity to the implementation 2)implementation contexts; 3)intervention optimisation and sustainability beyond the life of the funded projectSetting: The trial will take place in 10 UK MS centres. Each centre will have a local recruiter and Intervention Nurse. A trial manager based at the trial office will manage the research. A Project Management Group Trial Steering and Data Monitoring Committees will ensure adherence to research governance. Population: Adults with MS experiencing bothersome NBD and have not undertaken abdominal massage for 2 months.Health Technologies: abdominal massage for the relief of constipation. A pilot study of abdominal massage in people with MS (n=30) has been undertaken by the CI(17). This demonstrated trial feasibility and informed refinement of the abdominal massage protocol. Abdominal massage is routinely advocated in people with SCI but has no evidence base. Delayed transit colon time is the primary cause of NBD in people with ms The hypothesised mechanisms by which abdominal massage reduces constipation are a combination of direct colonic stimulation general relaxation and stimulating the parasympathetic nerves. In a subgroup of patients at one centre anal physiology tests will be undertaken which may have some predictive value. Transit study tests are part of these tests and all will be repeated at Week 24. Method: the recruiter will identify possible patients by reviewing their notes and a letter of introduction and an Expression of Interest Form will be posted 8 weeks before the patient’s routine clinic appointment. In addition patients may be approached at clinic by the PI. The trial manager will telephone those patients who express an interest to provide further information. A consent form baseline questionnaires and bowel diary will be posted for completion. Eligible consenting patients will be randomised. The Intervention Nurse will see participants at their clinic appointment for an additional 1 hour to deliver the intervention or at a more suitable time if preferred.Control Group (optimised bowel care): At the clinic appointment the participant’s usual bowel care will be reviewed and an Information Pack provided.. Intervention Group (optimised bowel care plus abdominal massage): In addition to the above the Intervention Nurse will teach the participant and/or their carer the abdominal massage and provide a massage training DVD. Participants will be advised to use the massage as an adjunct to their optimised bowel care and should last approximately 10 minutes. Telephone back up will be available during office hours. The Intervention Nurse will telephone all participants during Weeks 1-6 to discuss their bowel careOutcome measures (OCM 0 6 24 weeks).Staff at the 10 trial centres will not be involved with data collection. Improvement in symptoms are the most important clinical outcome in such a trial and therefore the outcome measures are self-completed questionnaires covering quality of life and neurogenic bowel dysfunction symptoms These will be posted to the participants from the trial office with a pre-paid SAE. Each participant will be given a unique trial number which will be used on the all data and data basesPrimary OCM: Neurogenic Bowel Dysfunction Score (NBDS)(24) records changes in NBD. Secondary OCM: Constipation Scoring System(23) measuring constipation symptoms; Qualiveen Questionnaire SF(22) measuring bladder function; the EQ-5D(25) measuring health status and a recently developed patient reported neurogenic bowel quality of life scale. A 7-day bowel diary will be completed prior and during the intervention and during Week 23. The participants will record when they do the massage. Transit study tests at base-line and Week 24 in a sub group of participants will be undertaken. A process evaluation and cost utility analysis will be also be undertaken. Sample size: The only published data available on the Neurogenic Bowel Dysfunction Score to inform sample size calculations is from our own pilot trial in the MS population. Based on data at 8 week follow-up a sample size of 60 per group would be indicated to detect a difference between groups of 4.21 (SD 7.02) at the 5% level of significance with 90% power. This sample size would also provide 80% power to detect a smaller difference of 3.70. To allow for drop-out of up to 20% we will inflate this sample size to 150. We have subsequently increased our sample size to 200 on the recommendation of the HTA reviewers (following removal of the SCI component).Analysis: Participants or the Intervention Nurse cannot be blinded to group allocation. However data will be gathered by participant-completed questionnaires and will be entered and analysed before unblinding. In an intention-to-treat analysis we will estimate the mean difference in NBDS score at 24 weeks between the intervention and control group using a general linear model. The process evaluation qualitative interviews will be analysed using Framework analysis and a realist evaluation of the context mechanisms and outcomes analysis. Project Timetable: Pre study - IRAS approval contract signing recruitment of trial manager and process evaluation researcher: 0-6 months study set up training day R&DMS study - 200 participants recruited by 10 sites over 12 month. Site one recruiting from month 6 site 10 recruiting from month 10. Recruitment completed at month 24 data collection completed by month 30 data input and analysis by month 36Team Expertise – members include experienced complex intervention trialists leading clinical experts and a CTU is providing trial support data management and statistical expertise


Research activity codes: 6.8 COMPLEMENTARY
Health categories: NEUROLOGICAL;ORAL AND GASTROINTESTINAL