Feasibility of abdominal massage for the alleviation of the symptoms of constipation in people with multiple sclerosis

ISRCTN	ISRCTN01328898
DOI	https://doi.org/10.1186/ISRCTN01328898
Secondary identifying numbers	08/NIR02/80

Submission date: 19/11/2008
Registration date: 05/01/2009
Last edited: 07/12/2012

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 of protocol

Not provided at time of registration

Contact information

Dr Doreen McClurg
Scientific

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

Phone	+44 (0)141 331 8105
Email	Doreen.mcclurg@gcal.ac.uk

Study information

Study design	Pilot study, two-group randomised controlled clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	ABMIMS
Study objectives	Abdominal massage will relieve some of the symptoms of constipation in people with multiple sclerosis.
Ethics approval(s)	Office for Research Ethics Committees Northern Ireland (ORECNI) 25th September 2008 (ref: 08/NIR02/80)
Health condition(s) or problem(s) studied	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
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 study start date	01/11/2008
Completion date	01/11/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	30
Key inclusion criteria	1. Constipation as defined by the Rome II criteria 2. Age range over 18 years, male or female
Key exclusion criteria	1. Bowel cancer 2. Stoma 3. Abdominal surgery (inside last year)
Date of first enrolment	01/11/2008
Date of final enrolment	01/11/2009

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

Nursing Midwifery and Allied Health Professions Research Unit (NMAHPRU)

Glasgow
G4 0BA
United Kingdom

Sponsor information

Nursing Midwifery and Allied Health Professions Research Unit (UK)
Research organisation

Glasgow Caledonian University
Buchanan House
Glasgow
G4 OBA
United Kingdom

Website	http://www/nmahpru.gcal.ac.uk
"ROR"	https://ror.org/03dvm1235

Funders

Funder type

Charity

Multiple Sclerosis Trust (UK)
Private sector organisation / Other non-profit organizations

Alternative name(s): MS, MS Trust
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2011		Yes	No