Abdominal massage for bowel dysfunction in people with multiple sclerosis
| ISRCTN | ISRCTN85007023 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85007023 |
| ClinicalTrials.gov (NCT) | NCT03166007 |
| Protocol serial number | 12/127 |
| Sponsor | Glasgow Caledonian University (UK) |
| Funder | Health Technology Assessment Programme |
- Submission date
- 17/06/2014
- Registration date
- 26/06/2014
- Last edited
- 31/07/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
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
doreen.mcclurg@gcu.ac.uk
Contact information
Scientific
NMAHP RU
Glasgow Caledonian University
Cowcaddens Road
Glasgow
G4 0BA
United Kingdom
| Phone | +44 (0)141 331 8105 |
|---|---|
| doreen.mcclurg@gcu.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | 2 group parallel design RCT |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Abdominal massage for neurogenic bowel dysfunction in people with multiple sclerosis: Abdominal Massage for Bowel Dysfunction Effectiveness Research (AMBER) |
| Study acronym | AMBER |
| Study objectives | Abdominal massage with advice on bowel management is more effective for the relief of symptoms compared to advice alone |
| Ethics approval(s) | West of Scotland Rec 4, 11/06/2014, ref. 14/WS/0111 |
| Health condition(s) or problem(s) studied | Multiple sclerosis/bowel disorders |
| Intervention | 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 | Other |
| Primary outcome measure(s) |
Neurogenic bowel dysfunction score |
| Key secondary outcome measure(s) |
1. Constipation scoring System |
| Completion date | 30/06/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 200 |
| Key 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 |
| Key exclusion criteria | MS relapse |
| Date of first enrolment | 01/07/2014 |
| Date of final enrolment | 30/06/2017 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
G4 0BA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2018 | Yes | No | |
| Protocol article | protocol | 29/03/2017 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
31/07/2019: ClinicalTrials.gov number added.
31/10/2018: Publication reference added.
31/03/2017: Publication reference added.