The AMBER study Abdominal Massage for Neurogenic Bowel Dysfunction in People with Multiple Sclerosis Background Objective Study Design and AMBER Study Centres Bowel dysfunction (constipation and/or faecal incontinence) is common in people with multiple sclerosis (MS), and is rated as the most severe impact of their disease above wheelchair dependence 1. Despite this, current treatment options are limited, poorly evaluated and complex 2. A feasibility study (funded by the MS Trust) demonstrated that it is possible for patients or carers to perform abdominal massage and in some cases this reduced the participant’s symptoms 3. The objective of this study is to determine if abdominal massage, undertaken by a carer or the patient themselves, is an effective and cost effective treatment of constipation in people with MS. Qualitative interviews with staff and patients will further validate the findings of the study. 9 months left for recruitment and results of the trial will be published in summer If you are interested in hearing more about the AMBER study please do get in touch with the AMBER study team. We would love to hear your thoughts. We do not want bowel issues to become a “taboo” subject. Lets talk about poo! Website: Contact Details: Kirsteen Goodman, NMHAP Research Unit, Glasgow Caledonian University, Glasgow, G4 0BA References 1.Nortvedt MW, Riise T, Frugard J, Mohn J, Bakke A, Myhr (2007) Prevalence of bladder, bowel and sexual problems among multiple sclerosis patients two to five years after diagnosis. Multiple Sclerosis. 13: Coggrave M, Wiesel PH, Norton C (2006) Management of faecal incontinence and constipation in adults with central neurological diseases. The Cochrane Database of systematic reviews, Issue 2. Art. No. CD DOI: / CD pub3 3.McClurg D, Hagen S, Hawkins S, Lowe-Strong A. (2011) Abdominal Massage for the Relief of Constipation in People with Multiple Sclerosis. Multiple Sclerosis. 17(2): AMBER study centres open to recruitment First patient was randomised on 22 nd Jan At the time of writing, 99 people with MS have been randomised (aim to recruit 200). 37 people with MS have completed the study (reached the 24 week follow up). No Serious Adverse Events. 44 interviews have been completed for the qualitative part of the study (both staff and patient interviews). Patients have high compliance with the bowel diary completion and data return of all CRFS. To date, the AMBER study has recruited ahead of schedule. Figure 1: Actual recruitment versus predicted in AMBER. The AMBER Study is A UK collaborative study funded by the National Institute for Health Research, Health Technology Assessment Programme (Project: 12/127/12) and sponsored by Glasgow Caledonian University (CI: Dr Doreen McClurg). Ethical approval was granted by the West of Scotland Research Ethics Committee. Site identifies person with MS, screens, confirms eligibility and arranges baseline visit (completes bowel dairy 7 days prior to visit). Consent, Baseline Questionnaires and Case Report Form (CRF) completion. Participant randomised to either “Intervention” (abdominal massage and advice) or “Control” (advice only). Massage training is provided and training DVD and materials given to participant to take home. During weeks 1 -6 the participant will receive follow up telephone calls from the site researcher and they will complete weekly bowel diaries, patient resource forms and QoL Qu Booklet (week 6 only). At weeks 12, 18 and 24 a patient resource form is completed. The end of study follow up occurs at week 24 during which they will complete one final bowel diary and the Qol Qu booklet. Primary outcome is the difference between the intervention and the control group in the change in NBD score at 24 weeks. Results What is next?