Condition category
Nervous System Diseases
Date applied
19/11/2008
Date assigned
05/01/2009
Last edited
07/12/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Doreen McClurg

ORCID ID

Contact details

Nursing Midwifery and Allied Health Professions Research Unit (NMAHPRU)
Glasgow Caledonian University
Buchanan House
Glasgow
G4 0BA
United Kingdom
+44 (0)141 331 8105
Doreen.mcclurg@gcal.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

08/NIR02/80

Study information

Scientific title

A randomised controlled pilot study to assess the feasibility of abdominal massage for the alleviation of the symptoms of constipation in people with multiple sclerosis

Acronym

ABMIMS

Study hypothesis

Abdominal massage will relieve some of the symptoms of constipation in people with multiple sclerosis.

Ethics approval

Office for Research Ethics Committees Northern Ireland (ORECNI) 25th September 2008 (ref: 08/NIR02/80)

Study design

Pilot study, two-group randomised controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Multiple sclerosis

Intervention

Following expressing an interest in the study, potential participants will be provided with verbal and written information concerning their involvement and informed consent will be obtained. Providing screening is satisfactory, participants will then be randomly allocated to a treatment and a control group. Baseline outcome measures will be undertaken at this point by a research assistant who will be blind to group allocation:
1. Constipation Scoring System
2. Neurogenic Bowel Dysfunction Score
3. Bowel Diary
4. 29-item Multiple Sclerosis Impact Scale (MSIS-29)
5. Qualiveen Questionnaire

The intervention group will then be visited in their own home, provided with advice on good bowel habits and they and/or their carers will be shown how to undertake abdominal massage. This will be undertaken daily for 15 minutes for 4 weeks. A DVD demonstrating the technique will be left, and they will be visited at least once a week by the clinician to provide further training and support.

The control group will be visited in their own home and provided with advice on good bowel habits. This group will be visited once a week for 4 weeks.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Constipation scoring system, undertaken at the end of the intervention period (week 4) and 4 weeks later (week 8).

Secondary outcome measures

1. Neurogenic Bowel Dysfunction Score
2. Bowel Diary
3. Qualiveen Questionnaire
4. 29-item Multiple Sclerosis Impact Scale (MSIS-29)

Outcome measures will be undertaken at the end of the intervention period (week 4) and 4 weeks later (week 8).

Overall trial start date

01/11/2008

Overall trial end date

01/11/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Constipation as defined by the Rome II criteria
2. Age range over 18 years, male or female

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Bowel cancer
2. Stoma
3. Abdominal surgery (inside last year)

Recruitment start date

01/11/2008

Recruitment end date

01/11/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nursing Midwifery and Allied Health Professions Research Unit (NMAHPRU)
Glasgow
G4 0BA
United Kingdom

Sponsor information

Organisation

Nursing Midwifery and Allied Health Professions Research Unit (UK)

Sponsor details

Glasgow Caledonian University
Buchanan House
Glasgow
G4 OBA
United Kingdom

Sponsor type

Research organisation

Website

http://www/nmahpru.gcal.ac.uk

Funders

Funder type

Charity

Funder name

Multiple Sclerosis Trust (UK)

Alternative name(s)

MS Trust

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

1. 2011 results in www.ncbi.nlm.nih.gov/pubmed/20940182

Publication citations

  1. Results

    McClurg D, Hagen S, Hawkins S, Lowe-Strong A, Abdominal massage for the alleviation of constipation symptoms in people with multiple sclerosis: a randomized controlled feasibility study., Mult. Scler., 2011, 17, 2, 223-233, doi: 10.1177/1352458510384899.

Additional files

Editorial Notes