Abdominal massage for bowel dysfunction in people with multiple sclerosis

ISRCTN ISRCTN85007023
DOI https://doi.org/10.1186/ISRCTN85007023
ClinicalTrials.gov number NCT03166007
Secondary identifying numbers 12/127
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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
doreen.mcclurg@gcu.ac.uk

Contact information

Dr Doreen McClurg
Scientific

NMAHP RU
Glasgow Caledonian University
Cowcaddens Road
Glasgow
G4 0BA
United Kingdom

Phone +44 (0)141 331 8105
Email doreen.mcclurg@gcu.ac.uk

Study information

Study design2 group parallel design RCT
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant 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 Doreen.mcclurg@gcu.ac.uk
Scientific titleAbdominal massage for neurogenic bowel dysfunction in people with multiple sclerosis: Abdominal Massage for Bowel Dysfunction Effectiveness Research (AMBER)
Study acronymAMBER
Study hypothesisAbdominal 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
ConditionMultiple sclerosis/bowel disorders
InterventionThis 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 typeOther
Primary outcome measureNeurogenic bowel dysfunction score
Secondary outcome measures1. 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 study start date01/07/2014
Overall study end date30/06/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants200
Participant inclusion criteria1. 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 exclusion criteriaMS relapse
Recruitment start date01/07/2014
Recruitment end date30/06/2017

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

NMAHP RU
Glasgow
G4 0BA
United Kingdom

Sponsor information

Glasgow Caledonian University (UK)
University/education

c/o Paul Flowers, PhD, AcSS
Institute for Applied Health Research
School of Health and Life Sciences
Glasgow Caledonian University
Cowcaddens Road
Glasgow
G4 OBA
Scotland
United Kingdom

Phone +44 (0)141 331 8617
Email P.Flowers@gcu.ac.uk
ROR logo "ROR" https://ror.org/03dvm1235

Funders

Funder type

Government

Health Technology Assessment Programme
Government organisation / National government
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 29/03/2017 Yes No
Results article results 01/10/2018 Yes No
HRA research summary 28/06/2023 No No

Editorial Notes

31/07/2019: ClinicalTrials.gov number added.
31/10/2018: Publication reference added.
31/03/2017: Publication reference added.