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 |
| Protocol serial number | 08/NIR02/80 |
| Sponsor | Nursing Midwifery and Allied Health Professions Research Unit (UK) |
| Funder | Multiple Sclerosis Trust (UK) |
- 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
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 |
|---|---|
| Doreen.mcclurg@gcal.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pilot study, two-group randomised controlled clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Constipation scoring system, undertaken at the end of the intervention period (week 4) and 4 weeks later (week 8). |
| Key secondary outcome measure(s) |
1. Neurogenic Bowel Dysfunction Score |
| Completion date | 01/11/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- Scotland
Study participating centre
Nursing Midwifery and Allied Health Professions Research Unit (NMAHPRU)
Glasgow
G4 0BA
United Kingdom
G4 0BA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
