Abdominal Massage for Bowel Dysfunction

NCT03166007 | Completed DMC

• 1 other identifier: 12/127
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Neurogenic Bowel Dysfunction; Abdominal massage

Outcome Measures

Primary Outcomes (1)

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

  NBDs is a 10 item questionnaire covering frequency of bowel movements, headache, perspiration or discomfort during defecation; medication for constipation or faecal incontinence; time spent on defecation; frequency of digital stimulation or evacuation; frequency of faecal incontinence; flatus incontinence; and perianal skin problems. Maximum score is 47 with over 14 considered severe.

  Baseline - 24 weeks

Secondary Outcomes (11)

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

  Baseline - 24 weeks

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

  Baseline - 24 weeks

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

  Baseline - 24 weeks

• 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

Study Arms (2)

Optimised bowel care + abdominal massage

EXPERIMENTAL

In addition to optimised bowel care as described below for the control group, the Intervention Nurse will teach the participant and/or their carer in the intervention arm how to deliver the abdominal massage. This will include viewing the massage DVD and the abdominal massage training booklet, as well as the demonstration of the technique on the participant by the Intervention Nurse.

Behavioral: Abdominal massage; Behavioral: Optimised bowel care

Optimised bowel care

ACTIVE COMPARATOR

During a 1 hour outpatient appointment, the participants' existing bowel care routine will be reviewed and optimised. For example, explaining the necessity of adequate fluid intake. No change in medication will be advocated.

Behavioral: Optimised bowel care

Interventions

Abdominal massage BEHAVIORAL

The participant should be supine and in a relaxed atmosphere, though this may depend on level of disability. The massage comprises 4 basic strokes (10minutes); Stroking from the small of the back over the iliac crest and down both sides of the pelvis towards the groin; Effleurage follows the direction of the ascending colon across the transverse colon and down the descending colon. This is repeated several times with increasing pressure; Palmar kneading tracks down the descending colon up the ascending colon and down the descending colon once again. Effleurage is repeated and continued with a relaxing transverse stroke over the abdomen; Vibration over the abdominal wall to relieve flatus concludes the massage session. The participants in this group will receive one telephone call per week for 6 weeks and again at 24 weeks to further discuss their bowel management.

Optimised bowel care + abdominal massage

Optimised bowel care BEHAVIORAL

During a 1 hour outpatient appointment, the participants' existing bowel care routine will be reviewed and optimised. For example, explaining the necessity of adequate fluid intake. No change in medication will be advocated. The participants in this group will also receive one telephone call per week during the following 6 week period to further discuss their bowel management and again at 24 week time point.

Optimised bowel care; Optimised bowel care + abdominal massage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Glasgow Caledonian University: lead

Study Sites (1)

Glasgow Caledonian University - NMAHP RU

Glasgow, Glasgow City of, G4 0BA, United Kingdom

Location

Related Publications (2)

• Todd CL, Johnson EE, Stewart F, Wallace SA, Bryant A, Woodward S, Norton C. Conservative, physical and surgical interventions for managing faecal incontinence and constipation in adults with central neurological diseases. Cochrane Database Syst Rev. 2024 Oct 29;10(10):CD002115. doi: 10.1002/14651858.CD002115.pub6.

  PMID: 39470206 DERIVED

• 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.

  PMID: 30375324 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Doreen McClurg

  Glasgow Caledonian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: May 24, 2017
• Study Start: June 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: March 1, 2017
• Last Updated: May 24, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)