Clinical trial NCT03166007: Abdominal Massage for Bowel Dysfunction
Official title: Abdominal Massage for Neurogenic Bowel Dysfunction in People With Multiple Sclerosis (AMBER Abdominal Massage for Bowel Dysfunction Effectiveness Research).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Neurogenic Bowel Dysfunction
Abdominal massage
Lead sponsor: Glasgow Caledonian University
Sponsor class: OTHER
First posted: 2017-05-24
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Neurogenic bowel dysfunction (NBD: constipation and/or faecal incontinence) is common in people with multiple sclerosis (MS) and is rated as the most severe impact of their disease/injury, above wheelchair dependence. Despite this, current treatment options are limited, poorly evaluated and complex.

This research aims to find out whether abdominal massage can help improve the symptoms of NBD in these patients. A small study has already shown that it is possible for patients or carers to perform abdominal massage and in some cases this helped the patient with their symptoms. A larger study is now required to confirm the results one way or another.

Patients with Multiple Sclerosis who attend one of the participating study centres who are bothered by constipation and or faecal incontinence will be asked to take part if they fit the other requirements for the trial. Those who agree to take part will be allocated at random to one of two groups, one will receive advice on the management of bowel dysfunction (called optimised bowel care), and the other will receive the same advice and will be taught how to do the abdominal massage (called abdominal massage and optimised bowel care). Both groups will visit a specialist nurse for 1 additional hour after their normal clinical appointment, or at an agreed time, to receive optimised bowel care advice. The patients in the intervention group +/or their carers will receive training on abdominal massage and a DVD/copy of demonstration of the massage for home use. All patients will also be called weekly for 6 weeks to discuss their bowel care.

The investigators will measure the results of treatment after 6 and 24 weeks. The investigators are primarily interested in whether patients in the intervention group (receiving optimized bowel care \& abdominal massage) have had more of an improvement in their NBD score at 24 weeks after they start the study that the control group (receiving optimized bowel care only). The investigators also want to find out how bad the constipation and bowel symptoms are, how much this affects their life and if they have any problems with their bladder. The investigators will also measure the costs of the treatments and any costs to the patient and their family, and balance these against any benefits of the intervention treatment.

During the trial the investigators will assess how well the optimized bowel care and abdominal massage training was delivered by speaking with nurses and listening to recordings of some of the telephone calls. The investigators will talk to the patients to find how they perceive the treatment they received and how they got on during the treatment period and once the treatment finished. The investigators will explore how the treatment delivery and patient's perceptions impact on the patients NBD symptoms.

The investigators have worked out from previous research that if 200 patients take part and most complete the trial, there will be enough data to successfully compare the treatments to find out if one is better than the other. Individual participation will be entirely voluntary and the investigators do not believe there are any risks associated with taking part.

Eligibility 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.

Primary outcomes:
measure: Change from Baseline to 24 weeks Neurogenic Bowel Dysfunction Score (NBDs)
timeFrame: Baseline - 24 weeks
Secondary outcomes:
measure: Neurogenic Bowel Dysfunction Questionnaire (NBD PROM) - change in Score from Baseline to 24 weeks
timeFrame: Baseline - 24 weeks
measure: Constipation Symptoms (Constipation Scoring System (CSS)) - change in Score from Baseline to 24 weeks
timeFrame: Baseline - 24 weeks
measure: Bowel Symptoms (7 day diary) - change in Score from Baseline to 24 weeks
timeFrame: Baseline - 24 weeks
measure: Radio Opaque Marker transit tests - change in Score from Baseline to 24 weeks
timeFrame: Baseline - 24 weeks
measure: Adherence to massage schedule (7 day diary) - change in Score from Baseline to 24 weeks
timeFrame: Baseline - 24 weeks
measure: Bladder Function (Qualiveen Questionnaire Short Form) - change in Score from Baseline to 24 weeks
timeFrame: Baseline - 24 weeks
measure: Health Status (EQ-5D-5L Health Questionnaire) - change in Score from Baseline to 24 weeks
timeFrame: Baseline - 24 weeks
measure: Change of medication (Concomitant Medication Form)
timeFrame: Over the study duration (24 weeks)
measure: Patient Resource Questionnaire - cost and use of NHS services (£)
timeFrame: Baseline, 1-6weeks, 12 weeks, 18 weeks and 24 weeks
measure: Patient Resource Questionnaire - cost to the patients and their families/carers (£)
timeFrame: Baseline, 1-6weeks, 12 weeks, 18 weeks and 24 weeks
measure: Patient Resource Questionnaire - incremental costs, QALYs and incremental cost per QALY derived by the economic model (£)
timeFrame: Baseline, 1-6weeks, 12 weeks, 18 weeks and 24 weeks
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Glasgow Caledonian University - NMAHP RU
state: Glasgow city of
Study officials:
affiliation: Glasgow Caledonian University
name: Doreen McClurg
role: PRINCIPAL_INVESTIGATOR
References:
citation: McClurg D, Harris F, Goodman K, Doran S, Hagen S, Treweek S, Norton C, Coggrave M, Norrie J, Rauchhaus P, Donnan P, Emmanuel A, Manoukian S, Mason H. Abdominal massage plus advice, compared with advice only, for neurogenic bowel dysfunction in MS: a RCT. Health Technol Assess. 2018 Oct;22(58):1-134. doi: 10.3310/hta22580.