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 measure
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 (if study stopped)
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
Funders
Funder type
Charity
Funder name
Multiple Sclerosis Trust (UK)
Alternative name(s)
MS, MS Trust
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
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
Basic results (scientific)
Publication list
1. 2011 results in www.ncbi.nlm.nih.gov/pubmed/20940182
Publication citations
-
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.