Abdominal Massage for Bowel Dysfunction — AMBER  

Multiple Sclerosis Clinical Trial

Official title: Abdominal Massage for Neurogenic Bowel Dysfunction in People With Multiple Sclerosis (AMBER Abdominal Massage for Bowel Dysfunction Effectiveness Research).

Status Completed

Clinical Trial Summary

The aim of the AMBER trial is to determine the effectiveness and cost effectiveness of abdominal massage as part of the adjunct to bowel care in people with Multiple Sclerosis who have problems with their bowel i.e. faecal incontinence and/or constipation.

Clinical Trial Description

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. Despite this, current treatment options are limited, poorly evaluated and complex.

This research aims to find out whether abdominal massage can help improve the symptoms of NBD in these patients. A small study has already shown that it is possible for patients or carers to perform abdominal massage and in some cases this helped the patient with their symptoms. A larger study is now required to confirm the results one way or another.

Patients with Multiple Sclerosis who attend one of the participating study centres who are bothered by constipation and or faecal incontinence will be asked to take part if they fit the other requirements for the trial. Those who agree to take part will be allocated at random to one of two groups, one will receive advice on the management of bowel dysfunction (called optimised bowel care), and the other will receive the same advice and will be taught how to do the abdominal massage (called abdominal massage and optimised bowel care). Both groups will visit a specialist nurse for 1 additional hour after their normal clinical appointment, or at an agreed time, to receive optimised bowel care advice. The patients in the intervention group +/or their carers will receive training on abdominal massage and a DVD/copy of demonstration of the massage for home use. All patients will also be called weekly for 6 weeks to discuss their bowel care.

The investigators will measure the results of treatment after 6 and 24 weeks. The investigators are primarily interested in whether patients in the intervention group (receiving optimized bowel care & abdominal massage) have had more of an improvement in their NBD score at 24 weeks after they start the study that the control group (receiving optimized bowel care only). The investigators also want to find out how bad the constipation and bowel symptoms are, how much this affects their life and if they have any problems with their bladder. The investigators will also measure the costs of the treatments and any costs to the patient and their family, and balance these against any benefits of the intervention treatment.

During the trial the investigators will assess how well the optimized bowel care and abdominal massage training was delivered by speaking with nurses and listening to recordings of some of the telephone calls. The investigators will talk to the patients to find how they perceive the treatment they received and how they got on during the treatment period and once the treatment finished. The investigators will explore how the treatment delivery and patient's perceptions impact on the patients NBD symptoms.

The investigators have worked out from previous research that if 200 patients take part and most complete the trial, there will be enough data to successfully compare the treatments to find out if one is better than the other. Individual participation will be entirely voluntary and the investigators do not believe there are any risks associated with taking part. ;

Related Conditions & MeSH terms

• Gastrointestinal Diseases
• Intestinal Diseases
• Multiple Sclerosis
• Neurogenic Bowel
• Sclerosis

• NCT number: NCT03166007
• Study type: Interventional
• Source: Glasgow Caledonian University
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Completion date: March 2017