Condition category
Nervous System Diseases
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status

Plain English Summary

Background and study aims?
Multiple sclerosis (MS) is a common life-long neurological condition primarily affecting younger adults. It causes a wide range of symptoms, including problems with muscle movement, balance and vision. Loss of normal bowel function, otherwise called neurogenic bowel dysfunction (NBD) occurs in 60% of these patients. This condition is called by damage to the nerves controlling defaecation and results in constipation and faecal incontinence (FI). Constipation can cause pain, and prolonged and difficult passing of stool. It can also, if left untreated, led to impaction (solid, immobile block of faeces in the rectum) which often needs to be treated in hospital. FI has devastating consequences for a person socially and psychologically. NBD can also result in a number of complications such as haemorrhoids, rectal prolapse, anal tear, and the worsening of urinary symptoms or limb spasticity. Treatment of the condition is a step-wise process. Patients are first advised on diet and fluid intake and treated with laxatives or constipating medication. If this proves unsuccessful, rectal interventions such as use of fingers to stimulate the bowel and suppositories are used. Finally, more expensive and invasive treatment can be used; this includes rectal irrigation (washing out the rectum with fluid), and surgery. Bowel care can play a significant part in the lives of patients with MS with some reporting spending hours trying to go to the toilet. Constipation is mainly caused by a decrease in the rate that food moves along the colon. In people with MS there is little effective or evidence based advice on management of bowel dysfunction. We did, however, conduct an initial study that suggested that it is of potential benefit as part of a package of care.

Who can participate?
Adults (18 or over) who have been diagnosed with MS and are willing give themselves a massage or have a carer able to so for them.

What does the study involve?
Patients are allocated at random to either an intervention group (abdominal massage and optimised bowel care) or a control group (optimised bowel care). Optimised means the participants usual bowel care and small non-medicinal changes, if warranted, following discussions with the nurse e.g. fluid intake. The intervention group are seen once for one hour at their routine out-patient clinic appointment. In addition to discussions of current bowel management they and or their carer are provided with an information pack and an abdominal massage training DVD. The nurse will undertake the massage on the participant and show them and/or the carer how to do it. The massage takes around 10 minutes and consists of 4 standard strokes: stroking, effleurage, palmar kneading and vibration. During the following 6 weeks home massage will be recommended as part of their usual bowel care programme, and weekly telephone calls will be made by the researcher to discuss the massage and bowel care. Telephone back-up during office hours will also be provided. The control group are also seen once for one hour at their routine out-patient clinic appointment. The nurse will discuss current bowel management, provide them with the information pack (minus the massage information) and will arrange to telephone them weekly during the following 6 week period to discuss bowel care.

What are the possible benefits and risks of participating?
There are no risks from the intervention per se. The benefits are an additional treatment which does not involve drugs etc, and can be part of a self-management program.

Where is the study run from?
Glasgow Caledonian University (UK)

When is study starting and how long is it expected to run for?
July 2014 to June 2017

Who is funding the study?
The Health Technology Assessment (HTA) Programme (UK)

Who is the main contact?
Dr Doreen McClurg

Trial website

Contact information



Primary contact

Dr Doreen McClurg


Contact details

Glasgow Caledonian University
Cowcaddens Road
G4 0BA
United Kingdom
+44 (0)141 331 8105

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Abdominal massage for neurogenic bowel dysfunction in people with multiple sclerosis: Abdominal Massage for Bowel Dysfunction Effectiveness Research (AMBER)



Study hypothesis

Abdominal massage with advice on bowel management is more effective for the relief of symptoms compared to advice alone

Ethics approval

West of Scotland Rec 4, 11/06/2014, ref. 14/WS/0111

Study design

2 group parallel design RCT

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the following contact details to request a patient information sheet: Dr Doreen McClurg, NMAHP RU, Glasgow Caledonian University, G4 0BA, or telephone 0141 331 9105 or email


Multiple sclerosis/bowel disorders


This is a two group study where patients are allocated at random to either:
1. The intervention group - patients and/or their carers receive training in abdominal massage and optimised bowel care
2. Control group - patients receive optimised bowel care only

Intervention type



Not Applicable

Drug names

Primary outcome measures

Neurogenic bowel dysfunction score

Secondary outcome measures

1. Constipation scoring System
2. Qualiveen questionnaire
3. SF 22
4. EQ 5D
5. Bowel diary
6. Transit study tests (one centre)

All questionnaire outcome data will be collected at baseline, and at 6 and 24 weeks. A massage diary will be completed during weeks 1-6 which will record when the massage was undertaken. A bowel diary will be completed by all patients during the week before the intervention starts, Week 6 and week 24.

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Diagnosis of MS
2. Over the age of 18
3. No contraindications to abdominal massage e.g. pelvic cancer, hiatus, inguinal or umbilical hernia, rectal prolapse, irritable bowel disease and pregnancy, skin disease
4. Willing to undertake massage or have a carer able to undertake the massage

Participant type


Age group




Target number of participants


Participant exclusion criteria

MS relapse

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

G4 0BA
United Kingdom

Sponsor information


Glasgow Caledonian University (UK)

Sponsor details

c/o Paul Flowers
Interim Associate Dean Research
Professor of Sexual Health Psychology
Chartered Psychologist
HCPC Registered Health Psychologist
Institute for Applied Health Research
School of Health and Life Sciences
Glasgow Caledonian University
Cowcaddens Road
United Kingdom
+44 (0)141 331 8617

Sponsor type




Funder type


Funder name

The Health Technology Assessment (HTA) Programme - 12/112 (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes