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ISRCTN
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ISRCTN01328898
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ClinicalTrials.gov identifier
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Public title
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Feasibility of abdominal massage for the alleviation of the symptoms of constipation in people with multiple sclerosis
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Scientific title
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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
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Acronym
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ABMIMS
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Serial number at source
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08/NIR02/80
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Study hypothesis
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Abdominal massage will relieve some of the symptoms of constipation in people with multiple sclerosis.
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Ethics approval
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Office for Research Ethics Committees Northern Ireland (ORECNI) 25th September 2008 (ref: 08/NIR02/80)
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Study design
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Pilot study, two-group randomised controlled clinical trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Multiple sclerosis
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Participants - inclusion criteria
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1. Constipation as defined by the Rome II criteria
2. Age range over 18 years, male or female
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Participants - exclusion criteria
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1. Bowel cancer
2. Stoma
3. Abdominal surgery (inside last year)
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Anticipated start date
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01/11/2008
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Anticipated end date
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01/11/2009
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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30
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Interventions
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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.
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Primary outcome measure(s)
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Constipation scoring system, undertaken at the end of the intervention period (week 4) and 4 weeks later (week 8).
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Secondary outcome measure(s)
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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).
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Sources of funding
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Multiple Sclerosis Trust (UK)
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Trial website
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Publications
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Contact name
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Dr
Doreen
McClurg
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Address
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Nursing Midwifery and Allied Health Professions Research Unit (NMAHPRU)
Glasgow Caledonian University
Buchanan House
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City/town
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Glasgow
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Zip/Postcode
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G4 0BA
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Country
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United Kingdom
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Tel
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+44 (0)141 331 8105
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Email
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Doreen.mclurg@gcal.ac.uk
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Sponsor
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Nursing Midwifery and Allied Health Professions Research Unit (UK)
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Address
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Glasgow Caledonian University
Buchanan House
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City/town
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Glasgow
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Zip/Postcode
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G4 OBA
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Country
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United Kingdom
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Sponsor website:
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http://www/nmahpru.gcal.ac.uk
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Date applied
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19/11/2008
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Last edited
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06/01/2009
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Date ISRCTN assigned
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05/01/2009
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