Abdominal Massage for Bowel Dysfunction

Abdominal Massage for Neurogenic Bowel Dysfunction in People With Multiple Sclerosis (AMBER Abdominal Massage for Bowel Dysfunction Effectiveness Research).

CompletedNot a drug-phase studyMS (type not specified)NCT03166007ISRCTN85007023

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Abdominal massage

Given to everyone in the trial

  • Optimised bowel care

What it measured

Main measures

  • Change from Baseline to 24 weeks Neurogenic Bowel Dysfunction Score (NBDs)

    Baseline - 24 weeks

    Bladder, bowel and sexual function

  • Neurogenic bowel dysfunction score

    Bladder, bowel and sexual function

Other measures (12)

  • Neurogenic Bowel Dysfunction Questionnaire (NBD PROM) - change in Score from Baseline to 24 weeks

    Baseline - 24 weeks

    Bladder, bowel and sexual functionQuality of life (reported by participants)

  • Constipation Symptoms (Constipation Scoring System (CSS)) - change in Score from Baseline to 24 weeks

    Baseline - 24 weeks

    Bladder, bowel and sexual function

  • Bowel Symptoms (7 day diary) - change in Score from Baseline to 24 weeks

    Baseline - 24 weeks

    Bladder, bowel and sexual function

  • Radio Opaque Marker transit tests - change in Score from Baseline to 24 weeks

    Baseline - 24 weeks

  • Adherence to massage schedule (7 day diary) - change in Score from Baseline to 24 weeks

    Baseline - 24 weeks

    Quality of life (reported by participants)

  • Bladder Function (Qualiveen Questionnaire Short Form) - change in Score from Baseline to 24 weeks

    Baseline - 24 weeks

    Bladder, bowel and sexual function

  • Health Status (EQ-5D-5L Health Questionnaire) - change in Score from Baseline to 24 weeks

    Baseline - 24 weeks

    Quality of life (reported by participants)

  • Change of medication (Concomitant Medication Form)

    Over the study duration (24 weeks)

  • Patient Resource Questionnaire - cost and use of NHS services (£)

    Baseline, 1-6weeks, 12 weeks, 18 weeks and 24 weeks

  • Patient Resource Questionnaire - cost to the patients and their families/carers (£)

    Baseline, 1-6weeks, 12 weeks, 18 weeks and 24 weeks

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

* Male or female over the age of 18 years; * Diagnosis of MS (in a stable phase i.e. no MS relapse for 3 months); * No major change of medication for 1 month e.g. introduction of disease modifying medications; * Individual is bothered by their bowel dysfunction, and; * Must not have used abdominal massage for at least 2 months.

Exclusion criteria

* Individuals who are unable to undertake the massage themselves or do not have a carer willing to do it; * Individuals who are unable to understand the study processes; * Individuals who have contraindications to abdominal massage e.g. history of abdominal/pelvic cancer, hiatus, inguinal or umbilical hernia, rectal prolapse, Inflammatory Bowel Disease, pregnancy and past history of volvulus. * Recent abdominal scars, abdominal wounds or skin disorders that may make abdominal massage uncomfortable.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The aim of the AMBER trial is to determine the effectiveness and cost effectiveness of abdominal massage as part of the adjunct to bowel care in people with Multiple Sclerosis who have problems with their bowel i.e. faecal incontinence and/or constipation.

Papers

Loading reviews and guidelines…

History

    1. Started

      Jun 2014

    2. Main results due

      Jan 2017

    3. Finished

      Mar 2017

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